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Chinese immigrant survivors of men's violence experience both significant mental health impacts from abuse and barriers to formal services. Therefore, we examined the preliminary efficacy of an innovative mobile-based empowerment-based intervention (self-compassion, health, and empowerment; SHE) that specifically focuses on abused Chinese immigrant women in the US. This pilot study used a two-arm randomized controlled design with repeated measures. A convenience sample (N = 50) of Chinese immigrant women who experienced past year intimate partner violence (IPV) were recruited online and randomly assigned to the intervention or control group (25 per group). We assessed IPV exposure, safety behaviors, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) symptoms, and self-compassion at baseline, post-intervention, and 8-week follow-up. Of 95 eligible participants, 50 (52.6%) agreed to participate and completed baseline data collection; intervention completion rate was 64%. We found a significant group and time interaction for self-judgment (a self-compassion component), with a significant reduction seen in the intervention group compared to the control group. Despite no other significant group differences observed over time, the intervention group showed consistent trends toward improvements in most outcome measures, including specific types of IPV (i.e., negotiation, psychological aggression, and sexual coercion), depressive and PTSD symptoms, self-compassion, and certain components of self-compassion (i.e., isolation and over-identification) when compared to the control group. Our findings suggest that the SHE intervention shows promise in improving the mental health well-being of Chinese immigrant survivors. However, a fully powered randomized controlled trial is warranted to determine its efficacy. Our intervention has the potential to be translated in the Chinese immigrant populations with the necessary organizational support. [ABSTRACT FROM AUTHOR]

Objectives: We investigated whether a specific exercise program for the neck–shoulder region reduces headache intensity, frequency, and duration, and how it influences neck disability among women with chronic headache compared to a control group. Design: Two-center randomized controlled trial. Subjects: 116 working-age women. Intervention: The exercise group (n = 57) performed a home-based program with six progressive exercise modules, over 6 months. The control group (n = 59) underwent six placebo-dosed transcutaneous electrical nerve stimulation sessions. Both groups performed stretching exercises. Main measures: The primary outcome was pain intensity of headache, assessed using the Numeric Pain Rating Scale. Secondary outcomes were frequency and duration of weekly headaches, and neck disability assessed using the Neck Disability Index. Generalized linear mixed models were used. Results: Mean pain intensity at baseline was 4.7 (95% CI 4.4 to 5.0) in the exercise group and 4.8 (4.5 to 5.1) in the control group. After 6 months the decrease was slight with no between-group difference. Headache frequency decreased from 4.5 (3.9 to 5.1) to 2.4 (1.8 to 3.0) days/week in the exercise group, and from 4.4 (3.6 to 5.1) to 3.0 (2.4 to 3.6) in the control group (between-group p = 0.017). Headache duration decreased in both groups, with no between-group difference. Greater improvement in the Neck Disability Index was found in the exercise group (between-group change −1.6 [95% CI −3.1 to −0.2] points). Conclusion: The progressive exercise program almost halved headache frequency. The exercise program could be recommended as one treatment option for women with chronic headache. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the effectiveness of solution-focused group counseling (SFGC) to reduce depressive symptoms and improve cognitive functions among Chinese rural older adults. Method: In a cluster randomized controlled trial, 290 participants were randomly assigned to a 12-session SFGC intervention or a control group. the Center for Epidemiological Studies Depression Scale and Mini-Mental State Examination was adopted to measure depressive symptoms and cognitive functions, respectively, at pretest and posttest. Results: Repeated measure ANOVAs showed a significant group by time effect for both measures. Paired sample t-tests showed that depressive symptoms significantly decreased in the intervention group, but not in the control group. Cognitive functions did not change in the intervention group, but significantly declined in the control group. Conclusions: Our findings support the feasibility and effectiveness of a culturally adapted SFGC for reducing depressive symptoms and protecting cognitive functions among the disadvantaged older adults in a developing country. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) on upper limb motor recovery during post-stroke rehabilitation. Design: Single-blind, randomized controlled trial. Setting: Four inpatient rehabilitation facilities. Subjects: A total of 204 stroke patients with unilateral upper limb motor impairment were randomly 1:1 allocated to TEAS or sham TEAS group. Baseline demographic and clinical characteristics were comparable between the two groups. Interventions: Both groups received conventional physical and occupational therapies. TEAS and sham TEAS therapy were administered to two acupoints (LI10 and TE5) with a pulse duration of 300 µ s at 2 Hz on the affected forearm for 30 times over 6 weeks. Outcome measures: The upper-extremity Fugl-Meyer score (primary outcome), manual muscle testing, modified Ashworth scale, Lindmark hand function score, and Barthel index were evaluated by blinded assessors at baseline, 2, 4, 6, 10, and 18 weeks. Results: The number of patients who completed the treatment was 99 and 97 in the TEAS and the sham group. No significant between-group difference was found in the Upper-Extremity Fugl-Meyer score, Modified Ashworth Scale, Lindmark hand function score, and Barthel Index after intervention and during follow-up. However, the TEAS group exhibited 0.29 (95% CI 0.02 to 0.55) greater improvements in Manual Muscle Testing of wrist extension than the sham group (p = 0.037) at 18 weeks. Conclusions: Administration of TEAS therapy to hemiplegic forearm could not improve the upper extremity motor recovery. However, TEAS on the forearm might provide potential benefits for strength improvement of the wrist [ABSTRACT FROM AUTHOR]

Children with low performance in early numeracy are at risk of facing learning difficulties in mathematics, but few trials have examined how this can be ameliorated. A total of 120 first-grade children (Mage = 6.4 years) were randomly assigned to an intervention or a control condition. The 14-week intervention targeted early numeracy skills and was delivered in small groups three times a week. Immediately after the initial 8-week intervention phase, moderate and positive effects were found on early numeracy (d = 0.19), word problem solving (d = 0.41), and approximate number sense (d = 0.35). However, only the effects on word problems were significant, and all effects disappeared after the children undertook a second 6-week intervention phase. Overall, results indicate that (a) early numeracy skills are malleable in low-performing children, but (b) frequent and long-term interventions are needed for the positive effects to last. [ABSTRACT FROM AUTHOR]

Objective: Specification of interventions and selection of controls are two methodological determinants for a successful acupuncture trial. However, current practice with respect to these two determinants is not fully understood. Thus, we conducted a cross-sectional survey to examine the specification of interventions and selection of controls among published randomized controlled trials (RCTs) of acupuncture. Study design and setting: We searched PubMed for acupuncture RCTs published in core clinical journals and complementary and alternative medicine (CAM) journals from January 2010 to December 2019 (10 years) and included RCTs that assessed treatment effects of acupuncture versus any type of control. We used network meta-analyses to explore whether there were differential treatment effects in patients with chronic pain when using sham acupuncture as a control versus using waiting list or no treatment. Results: Most of the 319 eligible RCTs specified well the style of acupuncture (86.8%), traditional acupuncture point locations (96.2%), type of needle stimulation (90.3%) and needle retention time (85.6%). However, other acupuncture details were less-frequently specified, including response sought (65.5%), needle manipulation (50.5%), number of needle insertions (21.9%), angle and direction of insertion (31.3%), patient posture (32.3%) and co-interventions (22.9%). Sham acupuncture (41.4%) was the most frequently used control, followed by waiting list or no treatment (32.9%). There was no differential treatment effect when using sham acupuncture versus waiting list/no treatment as a control (standardized mean difference = −0.15, 95% confidence interval: −0.91 to 0.62). Conclusion: Over a decade of research practice, important gaps have remained in the specification of acupuncture interventions, including response sought, needle manipulation, and co-interventions. While sham acupuncture has been widely used, waiting list or no treatment may also be considered as an appropriate control. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to examine the effectiveness of acupuncture in treating the symptoms and quality of life (QoL) of patients with moderate or severe acne vulgaris (AV). Methods: Participants were randomly assigned (1:1) to receive 12 treatment sessions of acupuncture or sham acupuncture over 4 weeks with 24 weeks of follow-up. The primary outcome was the change from baseline in the Skindex-16 scale total score at treatment completion. Secondary outcomes included Skindex-16 subscale score, Dermatology Life Quality Index scale total score, total lesion count and inflammatory lesion count, and visual analogue scale scores for itch and pain evaluation. Results: There was no statistically significant between-group difference for the primary outcome or any secondary outcomes after 4 weeks of treatment and at 16 and 28 weeks of follow-up, except for the Skindex-16 emotions subscale at week 4 (p = 0.026). No serious adverse events occurred in either group. Conclusion: Acupuncture may not effectively relieve the symptoms of patients with moderate or severe AV, or improve QoL. Given the limitations of a relatively short treatment course compared to other studies and the likelihood that sham acupuncture is not inert, further studies with treatment durations of 12 weeks or longer and a waitlist (no treatment) control or Western medicine-treated control group should be considered to evaluate the effects of acupuncture on AV. Trial registration number: ChiCTR-1900023649 (Chinese Clinical Trial Registry) [ABSTRACT FROM AUTHOR]

Despite increased prevalence of domestic violence and abuse (DVA), victimization through DVA often remains undetected in mental health care. To estimate the effectiveness of a system provider level training intervention by comparing the detection and referral rates of DVA of intervention community mental health (CMH) teams with rates in control CMH teams. We also aimed to determine whether improvements in knowledge, skills and attitudes to DVA were greater in clinicians working in intervention CMH teams than those working in control teams. We conducted a cluster randomized controlled trial in two urban areas of the Netherlands. Detection and referral rates were assessed at baseline and at 6 and 12 months after the start of the intervention. DVA knowledge, skills and attitudes were assessed using a survey at baseline and at 6 and 12 months after start of the intervention. Electronic patient files were used to identify detected and referred cases of DVA. Outcomes were compared between the intervention and control teams using a generalized linear mixed model. During the 12-month follow-up, detection and referral rates did not differ between the intervention and control teams. However, improvements in knowledge, skills and attitude during that follow-up period were greater in intervention teams than in control teams: β 3.21 (95% CI 1.18-4.60). Our trial showed that a training program on DVA knowledge and skills in CMH teams can increase knowledge and attitude towards DVA. However, our intervention does not appear to increase the detection or referral rates of DVA in patients with a severe mental illness. A low detection rate of DVA remains a major problem. Interventions with more obligatory elements and a focus on improving communication between CMH teams and DVA services are recommended. [ABSTRACT FROM AUTHOR]

Objectives: To determine if Cognitive Orientation to Occupational Performance was effective in improving performance and transfer of motor learning in children with developmental coordination disorder (with/without attention deficit hyperactivity disorder); and whether outcomes were maintained three months post-intervention. Design: Randomized waitlist-control trial (ClinicalTrials.gov ID: NCT02597751) Setting: BC Children's Hospital, Vancouver, Canada Subjects: Thirty-seven children with developmental coordination disorder and 41 children with co-occurring attention deficit hyperactivity disorder (all 8–12 years), randomized to treatment or waitlist groups. Interventions: One-hour of intervention once weekly for 10 weeks. Main Measures: (1) Canadian Occupational Performance Measure to measure self-perceived performance of motor goals (10-point scale); (2) Performance Quality Rating Scale to measure therapist-observed movement quality (10-point scale); and (3) Bruininks-Oseretsky Test of Motor Proficiency – 2nd ed. to measure overall motor skill ability/transfer of motor learning (percentile). Results: Both groups showed significant improvement (p < 0.001) in motor performance (developmental coordination disorder: pre: 2.7 ± 2.2, post: 7.0 ± 1.0; developmental coordination disorder with attention deficit hyperactivity disorder: pre: 2.3 ± 1.7, post: 7.0 ± 1.5) and movement quality (developmental coordination disorder: pre: 3.0 ± 1.5, post: 6.3 ± 1.7; developmental coordination disorder with attention deficit hyperactivity disorder: pre: 3.0 ± 1.9, post: 5.7 ± 2.3). Three months after treatment, children maintained their gains, but only children with developmental coordination disorder showed transfer of learning to overall motor skills (pre:12 ± 15, post:12 ± 12, follow-up:14 ± 20, p < 0.001). Conclusion: Intervention was similarly effective for children with developmental coordination disorder with/without attention deficit hyperactivity disorder in achieving and maintaining functional motor goals, but only children with developmental coordination disorder showed transfer of learning to other motor skills. [ABSTRACT FROM AUTHOR]

Objective: To study the long-term effectiveness of case-management rehabilitation intervention on vocational reintegration of patients after myocardial infarction (MI). Design: Blinded simple randomization was used to construct an intervention and control groups that were followed up for two years. Subjects and setting: 151 patients, aged 50.3 ± 5.9 years, who experienced uncomplicated MI and were enrolled in a cardiac rehabilitation program were recruited. Interventions: included an early referral to an occupational physician, tailoring an occupational rehabilitation program, based on individual patient needs, coordination with relevant parties, psychosocial intervention, intensive follow-up sessions during a two-year follow-up. Main measures: Return to work within six months of hospitalization and maintenance of employment at one and two years of follow-up. Results: Return-to-work (RTW) rate in the intervention group was 89% and nearly all maintained employment at one year of follow-up (92%) and two years of follow-up (87%). Moreover, almost all of them returned to and maintained their previous jobs. The corresponding figures were: 98%, 94% and 98%, respectively. The figures for the RTW and employment maintenance for the control group were: 74%, 75%, and 72%, respectively. Only about 75%, in this group kept their previous job. The case-management intervention was associated with increased odds of maintaining employment at follow-up of one year (OR = 5.89, 95% CI 1.42–24.30) and two years (OR = 3.12, 95% CI 1.01–10.03). Conclusions: The extended case-management rehabilitation intervention had a substantial positive impact on both the RTW of MI patients and their maintenance of employment at one and two years of follow-up. Trial Registration: This trial is registered at US National Institutes of Health #NCT04934735. [ABSTRACT FROM AUTHOR]

Objective: To determine the clinical effectiveness of adding virtual reality via the Nintendo Wii console and its Wii Balance Board to physiotherapy treatment in patients with total hip arthroplasty. Design: Randomized controlled trial. Setting: Clinical Hospital San Borja Arriaran, Santiago, Chile. Participants: A total of 73 patients over 50 years of age with total hip arthroplasty were randomly allocated to two groups. Interventions: The control group (n = 37) received 6 weeks of physiotherapy treatment; the intervention group (n = 36) received the same treatment plus virtual reality exercises with the Nintendo Wii console. Outcome measures: The two groups were assessed at baseline and after the 6 weeks of treatment. The primary outcome assessed was the function with the WOMAC questionnaire. The secondary outcomes were the Berg Balance Scale, distance covered with the six-minute walk test, and difference in weight load on the lower extremities. Results: A total of 73 patients, 37 patients in the control group (20 women; mean age of 70.9 ± 9.16 years) and 36 patients in the intervention group (18 women; mean age of 70.39 ± 9.02 years) were analyzed. At the end of the treatment, the difference between groups for the total WOMAC score was −10.4 points (p = 0.00), 4.7 points (p = 0.00) for the Berg Balance Scale, and 45.2 mt (p = 0.00) for the six-minute walk test All differences were in favor of the intervention group. Conclusions: In the short term, the addition of virtual reality via the Nintendo Wii and its Wii Balance Board platform showed statistically significant differences in the function of patients with total hip replacement, but these differences were not minimally clinically important. Trial registration : This research was registered in the Clinical Trials Registry of Australia and New Zealand, with reference ACTRN12618001252202. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019. Design: Randomized, controlled, parallel, double-blinded, three-arm clinical trial. Setting: Patients' homes through telerehabilitation devices. Subjects: Subjects with coronavirus disease 2019 in the acute phase. Interventions: Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group. Main measures: We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later. Results: From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables (p < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre–post intervention score: strength exercises group: 7.85 [6.82] – 4.54[4.82], breathing exercises group: 11.04 [6.49] – 5.32 [3.63], control group: 10.27 [6.49] – 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre–post intervention score: strength exercises group: 12.19 [4.42] – 13.58 [5.37], breathing exercises group: 11.18 [3.42] – 12.79 [4.00], control group: 10.45 [2.15] – 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale (R 2 = 0.548) and multidimensional dyspnoea-12 questionnaire (R 2 = 0.475). Conclusions: Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group. [ABSTRACT FROM AUTHOR]

Background: Chronic Achilles and patellar tendinopathy are a significant burden in physically active populations. High-volume image-guided injection (HVIGI) proposes to strip away associated neovascularity, disrupt painful nerve ingrowth, and facilitate rehabilitation. Purpose: To investigate the efficacy of HVIGI with and without steroid relative to placebo. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 62 participants were recruited between May 25, 2016, and March 5, 2020. Participants were men aged 18 to 55 years with Achilles or patellar tendinopathy of at least 6-month chronicity that had not improved with nonoperative management (including physical therapy and shockwave therapy), with ultrasound evidence of neovascularization, tendon thickening, and echogenic changes. They were assigned to the following groups: control (3 mL of subcutaneous 0.5% bupivacaine), HVIGI (10 mL of 0.5% bupivacaine and 30 mL of normal saline, ultrasound-guided between tendon and underlying fat pad), or HVIGI with steroid (HVIGIwSteroid; 0.25 mL of 100 mg/mL hydrocortisone). Clinicians and assessors were blinded. All participants were supervised through a pain-guided progressive loading program for 6 months postinjection. The main outcome measures were the Victoria Institute of Sport Assessments (VISA) for Achilles and patellar tendinopathy and the visual analog scale (VAS) for pain at 6 months postinjection. Results: The VISA score improved by a mean of 22.8 points (95% CI, 10.4-35.3 points; effect size [ES], 1.51) in the control group (n = 21), 18.6 points (95% CI, 9.1-28.0 points; ES, 1.31) in the HVIGI group (n = 21), and 18.5 points (95% CI, 3.4-33.6 points; ES, 0.88) in the HVIGIwSteroid group (n = 20). VAS pain improved by a mean of 15 points (interquartile range [IQR], -38.75, 8 points; ES, 0.39) in controls, 13 points (IQR,-34.0, 3.75 points; ES, 0.47) in the HVIGI group, and 27 points (IQR,-38.0, -1.0 points; ES, 0.54) in the HVIGIwSteroid group. The main effects were significant for time (P < .001) but not group (P ≥ .48), with no group x time interaction (P = .71). One participant was lost to follow-up from each group, multiple imputation was used for missing data points. No adverse events occurred. Conclusion: Study findings did not demonstrate superiority of HVIGI over control injection. [ABSTRACT FROM AUTHOR]

Frequent indoor tanning bed use is an established public health concern, yet research on tanning cessation interventions for frequent tanners is lacking. We describe the protocol for a brief, web-based tanning behavior change intervention and present evidence that it is acceptable and engaging to frequent indoor tanners. Lower tanning rates were not observed among participants receiving the intervention in a randomized controlled trial but participants’ interest in changing tanning increased. This intervention could be a useful approach to increasing frequent tanners’ interest in behavior change and openness to engaging within a more intensive, multi-component tanning cessation program. [ABSTRACT FROM AUTHOR]

Background: Although previous studies have reported good short-term results for superficial medial collateral ligament (sMCL) reconstruction, whether an augmented MCL repair is clinically equivalent remains unclear. Purpose/Hypothesis: The purpose of this study was to compare clinical outcomes between randomized groups that underwent sMCL augmentation repair and sMCL autograft reconstruction. The hypothesis was that there would be no significant differences in objective or subjective outcomes between groups. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were prospectively enrolled between 2013 and 2019 from 3 centers. Grade III sMCL injuries were confirmed via stress radiography. Patients were randomized to anatomic sMCL reconstruction versus augmented repair with surgical treatment, determined after examination under anesthesia confirmed sMCL incompetence. Postoperative visits occurred at 6 weeks and 6 months for repeat evaluation, with repeat stress radiography at final follow-up. Patient-reported outcome measures were obtained pre- and postoperatively at 6 months, 1 year, and final follow-up. The primary outcome measure was side-to-side difference on valgus stress radiographs at a minimum follow-up of 1 year. The two 1-sided t test procedure was used to test clinical equivalence for side-to-side difference in valgus gapping, and the Mann-Whitney U test was used to compare postoperative patient-reported outcome measures between groups. Results: A total of 54 patients were prospectively enrolled into this study. Of these, 50 patients had 6-month stress radiograph data, while 40 had 1-year postoperative valgus stress radiograph data. The mean (SD) patient age was 38.0 years (14.2), and body mass index was 25.0 (3.6). Preoperative valgus stress radiographs demonstrated 3.74 mm (1.1 mm) of increased side-to-side gapping overall, while it was 4.10 mm (1.46 mm) in the MCL augmentation group and 3.42 mm (0.55 mm) in the MCL reconstruction group. Postoperative valgus stress radiographs at an average of 6 months were obtained in 50 patients after surgery, which showed 0.21 mm (0.81 mm) for the MCL augmentation group and 0.19 mm (0.67 mm) for the MCL reconstruction group (P =.940). At final follow-up (minimum 1 year), median (interquartile range) Lysholm scores were significantly higher in the reconstruction group (90 [83-99]) as compared with the repair group (80 [67-92]) (P =.031). Final International Knee Documentation Committee (IKDC) scores were also significantly higher for the reconstruction group (85 [68-89]) versus the repair group (72 [60-78] (P =.039). Postoperative Tegner scores were not significantly different between the repair group (5 [3.5-6]) and the reconstruction group (5.5 [4-7]) (P =.123). Patient satisfaction was also not significantly different between repair (7.5 [5.75-9.25]) and reconstruction groups (9.0 [7-10]) (P =.184). Conclusion: This study found no difference in objective outcomes between an sMCL augmentation repair and a complete sMCL reconstruction at 1 year postoperatively, indicating equivalence between these procedures. Patient-reported clinical outcomes favored the reconstruction over a repair. In addition, this study demonstrated that anatomic-based treatment of MCL tears with an early knee motion program had a very low risk of graft attenuation and a low risk of arthrofibrosis. [ABSTRACT FROM AUTHOR]

Survivors of domestic and family violence (DFV) report poorer quality of life and worsening mental health. This study evaluated the effect of a counseling and education intervention on the mental health and help-seeking behaviors among pregnant women living with DFV. A parallel pilot randomized controlled trial was performed among 140 pregnant women attending an antenatal clinic of a tertiary hospital of Nepal. Using computer-generated random numbers, participants were randomized to the intervention group (a counseling session, an information booklet about DFV, and contact details of the counselor) or a control group (usual care plus a booklet containing contact details of local DFV support services). Outcome measures included mental health, quality of life (QOL), self-efficacy, social support, and safety planning behaviors. Analyses followed intention-to-treat, using the generalized estimating equation model. Intervention participants showed significant improvements in anxiety (β = −3.24, p <.001) and depression (β = −3.16, p <.001) at postintervention. Such improvements were also sustained at follow-up assessment (p <.001). Significant group and time interaction for QOL, social support, use of safety behaviors, and self-efficacy (p <.05) revealed a greater increase in these outcome measures among intervention participants at both follow-up assessments compared with the control group. This pilot integrated intervention showed promising outcomes in improving the mental health, social support, and the use of safety behaviors among women with DFV. This intervention could be incorporated into regular antenatal care as a strategy to identify and support victims of DFV. Larger controlled trials with longer follow-up are needed to support and expand on the current findings regarding the effectiveness of a psychosocial intervention targeting victims of DFV in resource-constrained settings. [ABSTRACT FROM AUTHOR]

Objective: To examine the effects of the provision of a cane, delivered to ambulatory people with chronic stroke, for improving walking and social participation. Design: Two-arm, randomized trial. Setting: Community-based. Participants: Ambulatory individuals with chronic stroke. Interventions: The experimental intervention was the provision of a single-point cane during one month. The control group received a placebo intervention. Outcome measures: Walking speed, step length, cadence, walking capacity, and walking confidence were measured without the cane to examine its rehabilitative effect. Walking speed was also measured with the cane for inclusiveness, and social participation was measured for examining carry over effects. Outcomes were measured at baseline, and after one and two months. Results: Fifty individuals were included. In the experimental group, mean age was 69 years (SD 14), and walking speed was 0.58 m/s (SD 0.17). In the control group, mean age was 68 years (SD 13), and walking speed was 0.63 m/s (SD 0.15). When walking without the cane, after one and after two months, there were no between-group differences in any measures. When walking with the cane, after one month, the experimental group walked 0.14 m/s (95% CI 0.05–0.23) faster than the control group and after two months, they were still walking 0.18 m/s (95% CI 0.06–0.30) faster. Conclusion: Use of a cane improved walking speed, only when participants walked with the cane. Use of cane for one month did not improve walking outcomes, when walking without the cane. People with stroke would need to continue to use the cane to maintain any benefits in walking speed. [ABSTRACT FROM AUTHOR]

Background: A strong recommendation against subacromial decompression surgery was issued in 2019. This leaves nonoperative care as the only treatment option, but recent studies suggest that the dose of strengthening exercise is not sufficient in current nonoperative care. At this point, it is unknown if adding more strengthening to current nonoperative care is of clinical value. Purpose: To assess the effectiveness of adding a large dose of shoulder strengthening to current nonoperative care for subacromial impingement compared with usual care alone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this double-blinded, pragmatic randomized controlled trial, we randomly allocated 200 consecutive patients referred to orthopaedic shoulder specialist care for long-standing shoulder pain (>3 months), aged 18 to 65 years and diagnosed with subacromial impingement using validated criteria, to the intervention group (IG) or control group (CG). Outcome assessors were blinded, and participants were blinded to the study hypothesis as well as to the treatment method in the other group. The CG received usual nonoperative care; the IG underwent the same plus an add-on intervention designed to at least double the total dose of shoulder strengthening. The primary outcome was the Shoulder Pain and Disability Index (SPADI; 0-100) at 4-month follow-up, with 10 points defined as the minimal clinically important difference. Secondary outcomes included shoulder strength, range of motion, health-related quality of life, and the Patient Acceptable Symptom State (PASS). Results: Intention-to-treat and per-protocol analyses showed no significant or clinically relevant between-group differences for any outcome. From baseline to 4-month follow-up, SPADI scores improved in both groups (intention-to-treat analysis; IG, –22.1 points; CG, –22.7 points; between-group mean difference, 0.6 points [95% CI, –5.5 to 6.6]). At 4 months after randomization, only 54% of the IG and 48% of the CG (P =.4127) reached the PASS. No serious adverse events were reported. Conclusion: Adding a large dose of shoulder strengthening to current nonoperative care for patients with subacromial impingement did not result in superior shoulder-specific patient-reported outcomes. Moreover, approximately half of all randomized patients did not achieve the PASS after 4 months of nonoperative care, leaving many of these patients with unacceptable symptoms. This study showed that adding more exercise is not a viable solution to this problem. Registration: NCT02747251 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Background: Few randomized controlled trials with a midterm follow-up have compared matrix-assisted autologous chondrocyte transplantation (MACT) with microfracture (MFx) for knee cartilage lesions. Purpose: To compare the structural, clinical, and safety outcomes at midterm follow-up of MACT versus MFx for treating symptomatic knee cartilage lesions. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 48 patients aged between 18 and 50 years, with 1- to 4-cm2 International Cartilage Repair Society (ICRS) grade III to IV knee chondral lesions, were randomized in a 1:1 ratio to the MACT and MFx treatment groups. A sequential prospective evaluation was performed using magnetic resonance imaging (MRI) T2 mapping, the MOCART (magnetic resonance observation of cartilage repair tissue) score, second-look arthroscopic surgery, patient-reported outcome measures, the responder rate (based on achieving the minimal clinically important difference for the Knee injury and Osteoarthritis Outcome Score [KOOS] pain and KOOS Sport/Recreation), adverse events, and treatment failure (defined as a reoperation because of symptoms caused by the primary defect and the detachment or absence of >50% of the repaired tissue during revision surgery). Results: Overall, 35 patients (18 MACT and 17 MFx) with a mean chondral lesion size of 1.8 ± 0.8 cm2 (range, 1-4 cm2) were followed up to a mean of 6 years postoperatively (range, 4-9 years). MACT demonstrated significantly better structural outcomes than MFx at 1 to 6 years postoperatively. At final follow-up, the MRI T2 mapping values of the repaired tissue were 37.7 ± 8.5 ms for MACT versus 46.4 ± 8.5 ms for MFx (P =.003), while the MOCART scores were 59.4 ± 17.3 and 42.4 ± 16.3, respectively (P =.006). More than 50% defect filling was seen in 95% of patients at 2 years and 82% at 6 years in the MACT group and in 67% at 2 years and 53% at 6 years in the MFx group. The second-look ICRS scores at 1 year were 10.7 ± 1.3 for MACT and 9.0 ± 1.8 for MFx (P =.001). Both groups showed significant clinical improvements at 6 years postoperatively compared with their preoperative status. Significant differences favoring the MACT group were observed at 2 years on the KOOS Activities of Daily Living (P =.043), at 4 years on all KOOS subscales (except Symptoms; P <.05) and the Tegner scale (P =.008), and at 6 years on the Tegner scale (P =.010). The responder rates at 6 years were 53% and 77% for MFx and MACT, respectively. There were no reported treatment failures after MACT; the failure rate was 8.3% in the MFx group. Neither group had serious adverse events related to treatment. Conclusion: Patients who underwent MACT had better structural outcomes than those who underwent MFx at 1 to 6 years postoperatively. Both groups of patients showed significant clinical improvements at final follow-up compared with their preoperative status. MACT showed superiority at 4 years for the majority of the KOOS subscales and for the Tegner scale at 4 to 6 years. The MACT group also had a higher responder rate and lower failure rate at final follow-up. Registration: NCT01947374 (ClinicalTrials.gov identifier). [ABSTRACT FROM AUTHOR]

Background: Previous observational studies have suggested poor results of arthroscopic surgery for the treatment of acetabular labral tears in patients older than 40 years. Purpose: To compare hip arthroscopy versus nonoperative management for symptomatic labral tears in patients older than 40 years who have limited radiographic osteoarthritis. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this single-surgeon, parallel randomized controlled trial, patients older than 40 years who had symptomatic, MRI-confirmed labral tears and limited radiographic osteoarthritis (Tönnis grades 0-2) were randomized 1:1 to arthroscopic surgery with postoperative physical therapy (SPT) or physical therapy alone (PTA) using an electronic randomization program. PTA patients who achieved unsatisfactory improvement were permitted to cross over to SPT after completing ≥14 weeks of physical therapy. The primary outcomes were International Hip Outcome Tool (iHOT-33) and modified Harris Hip Score (mHHS) at 12 months after randomization, and secondary outcomes included other patient-reported outcome measures and the visual analog scale. Outcomes were assessed at baseline and at 3, 6, and 12 months after randomization. Primary analysis was performed on an intention-to-treat basis using linear mixed-effect models. Sensitivity analyses included modified as-treated analysis and treatment-failure analysis. Due to infeasibility, patients and health care providers were both unblinded. Results: The study enrolled 90 patients (46 [51.1%] SPT; 44 [48.9%] PTA); of these, 81 patients (42 [51.9%] SPT; 39 (48.1%) PTA) completed 12-month follow-up. A total of 28 of the 44 PTA patients crossed over to SPT within the study period (63.6% crossover). Intention-to-treat analysis revealed significantly greater iHOT-33 scores (+12.11; P =.007) and mHHS scores (+6.99 points; P =.04) in the SPT group than the PTA group at 12 months. Modified as-treated analysis revealed that these differences exceeded the minimal clinically important difference of 10.0 points (SPT-PTA iHOT-33, +11.95) and 8.0 points (SPT-PTA mHHS, +9.76), respectively. Conclusion: In patients older than 40 years with limited osteoarthritis, arthroscopic acetabular labral repair with postoperative physical therapy led to better outcomes than physical therapy alone. Thus, age over 40 years should not be considered a contraindication to arthroscopic acetabular labral repair. Registration: NCT03909178 (ClinicalTrials.gov identifier) [ABSTRACT FROM AUTHOR]

Background: Evidence for the effect of minimal acupuncture in infants with colic is limited. Aim: To compare the effect of standardized minimal acupuncture, individualized acupuncture (where traditional acupuncture points were chosen according to the infant's symptoms) and no acupuncture on objective measures of stooling, feeding and sleeping in infants with colic (based on diaries) and perceived changes in these parameters (based on parental questionnaires). Methods: This was a secondary analysis of a multicentre randomized controlled three-armed trial conducted in four counties in Sweden between January 2013 and May 2015 (ACU-COL). The effect on crying has already been published and showed a decrease in crying time for the acupuncture groups. Infants, 2–8 weeks old, who cried and fussed for more than 3 h/day for more than 3 days/week, and thereby fulfilled the criteria for infantile colic, received four extra visits to their ordinary child health centre. The infants (n = 147) were randomly allocated via a computer-generated list to standardized minimal acupuncture at LI4 for 5 s (group A, n = 48), semi-standardized individual acupuncture with a maximum of five insertions for up to 30 s (group B, n = 49), or no acupuncture (group C, n = 48). The parents and the ordinary staff were blinded. Data were collected using: (1) diaries at baseline, during the two intervention weeks and 1-week follow-up; and (2) questionnaires with quantitative and qualitative components used at the second and fourth visits and during a follow-up telephone call. Outcomes were the changes in frequency of stooling and in hours of sleep per day. Results: There were no differences between groups for stooling, feeding, or sleeping at any time point according to data from the diaries. At the follow-up phone call, more parents in groups A and B (compared to group C) perceived that feeding and sleep had changed and that the symptoms of colic had improved. [ABSTRACT FROM AUTHOR]

Objective: We aimed to explore the feasibility of evaluating the comparative effectiveness and safety of electroacupuncture (EA) relative to manual acupuncture (MA) for the treatment of knee osteoarthritis (KOA). Methods: A multicenter randomized controlled clinical trial was conducted in Beijing from September 2017 to January 2018. A total of 60 participants with KOA were randomly allocated to either EA (n = 30) or MA (n = 30) groups. Participants in the EA group were treated with EA at six to seven local traditional acupuncture points or ah shi points, and two to three distal points. Participants in the MA group had the same schedule as the EA group except that the electrical apparatus featured a working power indicator without actual current output, constituting a sham EA procedure, in order to blind participants. Both groups received 24 sessions over 8 weeks. The primary outcome was response rate, defined as a change of ⩾50% from baseline in the total scores of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) after 8 weeks. Secondary outcomes included pain, stiffness, function, quality of life, and acupuncture-related adverse events (AEs) at 4 and 8 weeks. Results: Of 60 participants randomized, 53 (88%) completed the study. Response rates were 43% for the EA group and 30% for the MA group by the intention-to-treat analysis. Although significant differences were observed in WOMAC pain, stiffness, and function scores within both groups, between-group differences at 8 weeks did not reach statistical significance (odds ratio = 1.75 (95% confidence interval = 0.593–5.162)). Rates of AEs were low and similarly distributed between groups. Conclusion: Both EA and MA interventions in KOA were feasible and appeared safe. Whether or not EA may have a stronger impact on pain and function requires further evaluation through larger, adequately powered, randomized controlled trials. Trial registration number: NCT03274713. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group (n = 166) or control group (n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke. [ABSTRACT FROM AUTHOR]

Objective: To compare the effectiveness of supervised physical therapy program versus non-supervised on pain, functionality, fear of movement and quality of life in patients with non-specific chronic low back pain. Design: A randomized double-blind clinical trial. Setting: Clinical outpatient unit; home. Subjects: A total of 64 participants with non-specific chronic low back pain were randomized into either supervised exercise group (n = 32) or non-supervised home exercise group (n = 32). Interventions: The supervised group was treated with therapy exercises (strengthen lumbopelvic musculature), while the non-supervised received an informative session of the exercises, which were performed un-supervised at home. Both groups received three weekly sessions for eight weeks. Main Measures: Pain, disability, fear of movement, quality of life, trunk muscle endurance and trunk anteflexion motion were assessed at baseline, two, and six months of follow-up. Results: Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain (P = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland–Morris Disability Questionnaire (P = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index (P = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. Conclusion: Patients with chronic low back pain who received supervised exercise showed more improvement in both the short and long term in all patient-rated outcomes over the non-supervised group, but the differences were small and not clinically significant. [ABSTRACT FROM AUTHOR]

Objective: To analyze the effectiveness of an electrotherapy intervention with galvanic current on symptoms associated with Raynaud's phenomenon. Design: Single-blind randomized controlled trial, parallel design (1:1 ratio) and intention-to-treat analysis. Setting: Virgen de las Nieves Hospital, Granada, Spain. Subjects: Thirty-four participants with Raynaud's phenomenon, with a mean (SD) age of 43.43 (17.62) years. Interventions: The patients were randomly assigned to a control group with conservative treatment (anti-inflammatory, vasodilatory and analgesic drugs) or an intervention group that received conservative treatment and vasodilatory electrical stimulation during seven weeks, three times/week for a total of 20 sessions. Main measures: The primary outcome was the number of attacks. Secondary outcomes were pain, peripheral blow flow, oxygen saturation, upper limb disability, central sensitization, pain catastrophizing and temperature recovery. All outcomes were assessed at baseline, posttreatment and at two months of follow-up. Results: The galvanic current electrotherapy group showed significantly greater improvements in the number of attacks (mean difference = 26.3, 95% confidence interval (CI) = 14.4 to 38.3), pre-cold stress pain (95% CI = 0.6 to 2.4), radial artery blood flow (95% CI = −7.8 ⩾ x ⩽ 1.3), ulnar artery blood flow (95% CI = −8.63 to 0.60), oxygen saturation (95% CI = −1.7 ⩾ x ⩽ −0.29), upper limb disability (95% CI = 1.1 to 22.3), central sensitization (95% CI = 6.7 to 18.2) and temperature recovery (95% CI = −5.7 ⩾ x ⩽ −0.32) than the conservative treatment group. Conclusion: This study suggests that a complementary treatment with galvanic current in combination to conservative approach is superior to conservative applied as isolate, in reducing the clinical manifestations and disability in Raynaud's phenomenon. [ABSTRACT FROM AUTHOR]

Objective: To evaluate a group-based music intervention in patients with Parkinson's disease. Design: Parallel group randomized controlled trial with qualitative triangulation. Setting: Neurorehabilitation in primary care. Subjects: Forty-six patients with Parkinson's disease were randomized into intervention group (n = 26), which received training with the music-based intervention, and control group (n = 20) without training. Interventions: The intervention was delivered twice weekly for 12 weeks. Main measures: Primary outcome was Timed-Up-and-Go subtracting serial 7's (dual-task ability). Secondary outcomes were cognition, balance, concerns about falling, freezing of gait, and quality of life. All outcomes were evaluated at baseline, post-intervention, and three months post-intervention. Focus groups and individual interviews were conducted with the intervention group and with the delivering physiotherapists. Results: No between-group differences were observed for dual-task ability. Between-group differences were observed for Falls Efficacy Scale (mean difference (MD) = 6.5 points; 95% confidence interval (CI) = 3.0 to 10.0, P = 0.001) and for Parkinson Disease Questionnaire-39 items (MD = 8.3; 95% CI = 2.7 to 13.8, P = 0.005) when compared to the control group post-intervention, but these were not maintained at three months post-intervention. Three themes were derived from the interviews: Expectations versus Results, Perspectives on Treatment Contents, and Key Factors for Success. Conclusion: Patient-reported outcomes and interviews suggest that the group-based music intervention adds value to mood, alertness, and quality of life in patients with Parkinson's disease. The study does not support the efficacy in producing immediate or lasting gains in dual-tasking, cognition, balance, or freezing of gait. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to compare the effectiveness of a combined intervention of manual therapy and exercise (MET) versus usual care (UC), on disability, pain intensity and global perceived recovery, in patients with non-specific chronic neck pain (CNP). Design: Randomized controlled trial. Setting: Outpatient care units. Subjects: Sixty-four non-specific CNP patients were randomly allocated to MET (n = 32) or UC (n = 32) groups. Interventions: Participants in the MET group received 12 sessions of mobilization and exercise, whereas the UC group received 15 sessions of usual care in physiotherapy. Main measures: The primary outcome was disability (Neck Disability Index). The secondary outcomes were pain intensity (Numeric Pain Rating Scale) and global perceived recovery (Patient Global Impression Change). Patients were assessed at baseline, three weeks, six weeks (end of treatment) and at a three-month follow-up. Results: Fifty-eight participants completed the study. No significant between-group difference was observed on disability and pain intensity at baseline. A significant between-group difference was observed on disability at three-week, six-week and three-month follow-up (median (P25–P75): 6 (3.25–9.81) vs. 15.5 (11.28–20.75); P < 0.001), favouring the MET group. Regarding pain intensity, a significant between-group difference was observed at six-week and three-month follow-up (median (P25–P75): 2 (1–2.51) vs. 5 (3.33–6); P < 0.001), with superiority of effect in MET group. Concerning the global perceived recovery, a significant between-group difference was observed only at the three-month follow-up (P = 0.001), favouring the MET group. Conclusion: This study's findings suggest that a combination of manual therapy and exercise is more effective than usual care on disability, pain intensity and global perceived recovery. [ABSTRACT FROM AUTHOR]

Background: Overactive bladder is prevalent in adults over 40 years of age and its prevalence increases with age. The use of acupuncture in adults with overactive bladder is increasing globally. However, its effectiveness/efficacy and safety have not yet been confirmed. Objective: To determine the effectiveness/efficacy and safety of acupuncture and to identify the pattern of commonly used traditional acupuncture points in the management of overactive bladder in adults. Methods: Ten electronic English and Chinese language databases were systematically searched and two English together with four Chinese journals relevant to acupuncture were manually searched in libraries for randomised controlled trials (RCTs) of acupuncture for overactive bladder in adults from their inception to March 2017. The Cochrane risk of bias tool was used to assess the methodological quality of the RCTs. RevMan v.5.3 software was employed for data analysis. Results: Seven eligible trials involving 695 participants were included. Meta-analysis showed that acupuncture was comparable to drugs (tolterodine tartrate/solifenacin) in the reduction of micturition episodes over 24 hours (pooled standardised mean difference (SMD) 0.36, 95% CI −0.23 to 0.95; I2=83%), increase in voided volume of each micturition episode (pooled SMD −0.15, 95% CI −0.36 to 0.05; I2=0%), and reduction of overactive bladder symptom score (pooled SMD −0.23, 95% CI −1.30 to 0.85; I2=91%). In addition, acupuncture was not significantly different compared with placebo in the reduction of overactive bladder symptom score (pooled SMD −2.36, 95% CI −5.64 to 0.93; I2=97%). No serious adverse events were reported. Conclusions: No significant differences in effectiveness or efficacy were found between acupuncture and drug or between verum and sham acupuncture, respectively. Further high-quality studies are required. [ABSTRACT FROM AUTHOR]

Objective: To verify the effect of adjusting the challenge–skill balance with respect to rehabilitation process. Design: A single-blind, two-arm, parallel-group, randomized controlled trial. Setting: Recovery rehabilitation unit of Harue Hospital, Japan. Subjects: The trial included 72 clients (mean (SD): age, 74.64 (9.51) years; Functional Independence Measure score, 98.26 (15.27)) with cerebral or spinal disease or musculoskeletal disease. Interventions: Clients were randomly divided into two groups: the experimental group, who received occupational therapy with adjustment of the challenge–skill balance, and the control group who received conventional occupational therapy. Time from admission to discharge was considered the implementation period; the final evaluation was conducted at three months after discharge. Main measures: The primary outcome was subjective quality of life (Ikigai-9). Secondary outcomes were the health-related quality of life (EuroQol–5 Dimensions, Five Levels (EQ-5D-5L)), the Flow State Scale for Occupational Tasks, and the Functional Independence Measure. A cost-effectiveness analysis was conducted using total cost and quality-adjusted life-year based on the EQ-5D-5L. Results: Significant differences were observed between the experimental and control groups with respect to the Ikigai-9 score (P = 0.008) and EQ-5D-5L (P = 0.038), and the effect sizes were 0.76 (95% confidence interval [CI]: 0.27–1.24) and 0.62 (95% CI: 0.14–1.10), respectively. No significant between-group differences in other outcomes were observed, for example, the Functional Independence Measure score improved in both experimental and control groups (119.80 (5.50) and 118.84 (6.97), respectively. The incremental cost-effectiveness ratio was US$5518.38. Conclusions: Adjusting the challenge–skill balance may be a useful approach to improve the participant's subjective quality of life in the rehabilitation process. [ABSTRACT FROM AUTHOR]

Objective: To test the effectiveness of an educational intervention including "face to face" training, compared to a standard information program, to reduce microstomia in women with systemic sclerosis. Design: Single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Setting: Hospital wards of a large Italian dermatological reference center. Subjects: Female inpatients with diagnosis of systemic sclerosis. Interventions: For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The control group was assigned to educational materials alone (i.e. brochures and DVD), while the experimental group, in addition to the same educational materials, received specific "face-to-face" interventions, repeated at each follow-up visit. Main measures: Primary outcome was measurement of the opening of the mouth. Secondary outcomes was the self-reported mouth disability. Results: The intention-to-treat analysis included 63 patients. Compared to the baseline measurement, we observed an increase of the mouth opening of 0.31 cm (95% confidence interval: 0.13–0.49), P = 0.003; in the control group, the increase was 0.13 cm (95% confidence interval: 0.01–0.25), P = 0.06. The difference in improvement between the two groups was not statistically significant (P = 0.10); however, it reached statistical significance in the per-protocol analysis (39 patients, P = 0.02). Conclusion: Face-to-face nursing rehabilitation training seems to improve microstomia to a greater extent, when compared to a standard intervention based only on written and audio-visual materials. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to test and compare the effect of (1) a systematic discharge assessment with targeted advice and (2) a motivational interview followed by a home visit. Design: This was a three-armed randomized controlled study. Setting: This study was conducted in the Medical department in a university hospital. Subjects: Patients ⩾65 years of age with health problems at discharge participated in the study. Interventions: Group A (n = 117): patients were informed of health problems and self-care interventions; Group B (n = 116): a motivational conversation targeting activities of daily living with a home care nurse and a home visit. Main measures: The main measures of this study were readmissions, handgrip strength, chair-to-stand test, health-related quality of life, depression signs, mortality, and call on municipality services. Results: Risk of readmission was reduced for intervention groups by 30% (A; P = 0.26) and 22 % (B; P = 0.46). Mean number of days to first readmission was 49.5 (±51.0) days for the control group (n = 116) and 57.9 (±53.6) and 67.2 (±58.1) days for the intervention groups A (P = 0.43) and B (P = 0.10), respectively. Mean loss of handgrip strength was 10.6 (±16.6) kg for men in the control group and 7 (±19.2) and 1.4 (±17.1) kg for the intervention groups A (P = 0.38) and B (P = 0.01), respectively. Health-related quality of life improved with 0.3 (±23.7) points in the control group and 7.4 (±24.4) and 3.2 (±22.3) points in the intervention groups A (P = 0.04) and B (P = 0.37), respectively. In total, 17 (16.3%) in the control group were provided with assistive devices after three months and 8 (7.3%) and 19 (17.6%) in the intervention groups A (P = 0.04) and B (P = 0.81), respectively. Conclusion: The interventions reduced the risk of readmission and improved handgrip strength, quality of life, and use of assistive devices. [ABSTRACT FROM AUTHOR]

Background: Throwing injuries of the shoulder and elbow are common among youth baseball players. Hypothesis: A prevention program will reduce the incidence of throwing injuries of the shoulder and elbow by 50% among youth baseball players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The authors block randomized 16 youth baseball teams consisting of 237 players aged 9 to 11 years into an intervention group (8 teams, 117 players) and a control group (8 teams, 120 players). The intervention program consisted of 5 stretching, 2 dynamic mobility, and 2 balance training exercises performed during warm-up. Both groups were followed up for 12 months, during which the incidence of shoulder and elbow injuries was recorded. In addition, ball speed during pitching as a performance-related factor and variables of physical function (passive range of motion of the elbow, shoulder and hip, dynamic balance, and thoracic kyphosis angle) were assessed during the pre- and postintervention periods. Results: The incidence of shoulder and elbow injuries in the intervention group (1.7 per 1000 athlete-exposures) was significantly lower than that in the control group (3.1 per 1000 athlete-exposures) (hazard ratio, 1.940; 95% CI, 1.175-3.205; P =.010). The factors related to pitching performance, as assessed by ball speed, tended to increase in the intervention group as compared with the control group (P =.010). The program also improved shoulder horizontal adduction deficits on the dominant side, hip internal rotation on the nondominant side, and the thoracic kyphosis angle. Conclusion: A prevention program decreases throwing injuries of the shoulder and elbow and enhances the parameter of pitching performance in youth baseball players. [ABSTRACT FROM AUTHOR]

Objective: To investigate the concomitant effects of two patient-directed interventions for post-stroke depressive symptoms on caregivers' well-being. Design: Secondary analyses of the results of a randomized controlled trial. Subjects: Fifty caregivers of stroke patients receiving outpatient rehabilitation. Interventions: Stroke patients and their caregivers were randomly allocated to either cognitive-behavioural therapy augmented with movement or occupational therapy (n = 23) or computerized cognitive training (n = 27) to alleviate depressive symptoms in patients. Main measures: Emotional burden (Involvement Evaluation Questionnaire), practical burden (Caregiver Strain Index), mental health (General Health Questionnaire) and emotional complaints (Hospital Anxiety and Depression Scale). Results: Caregivers of patients who received cognitive-behavioural therapy reported significantly higher mental health levels (mean difference (MD) = 1.78, 95% confidence interval (CI) = 0.43–3.13, P = 0.01) and less worrying about patients' well-being (MD = 1.9, 95% CI = 0.56–3.24, P < 0.01). In addition, there were positive time effects on the Involvement Evaluation Questionnaire for Brain Injury, particularly the subscales Worrying, Supervision and Tension. Conclusion: The results suggest that augmented cognitive-behavioural therapy aimed at improving patients' emotional, behavioural and social functioning positively affects some aspects of caregivers' well-being. [ABSTRACT FROM AUTHOR]

Objective: To assess the costs, effects, and cost-utility of an accelerated physiotherapy programme versus a standard physiotherapy programme following resurfacing hip arthroplasty. Design: A cost-utility analysis alongside a randomized controlled trial. Setting: A UK National Health Service hospital and patients' homes. Subjects: A total of 80 male resurfacing hip arthroplasty patients randomized post procedure to one of the two programmes. Interventions: The accelerated physiotherapy programme commenced in hospital with patients being fully weight bearing, without hip precautions, and following a range of exercises facilitating gait re-education, balance, and lower limb strength. Standard physiotherapy commenced in hospital, but hip precautions were used and exercises were only partially weight bearing. In both groups, patients continued with their exercises at home for an eight-week period. Main measures: Data on healthcare contacts were collected from patients to 12 months and costed using unit costs from national sources. Information was also collected on patients' costs. Health-related quality of life was measured using the EuroQol EQ-5D questionnaire and used to estimate quality-adjusted life years (QALYs) to 12 months. Mean costs and QALYs for each trial arm were compared. Results: On average, the accelerated physiotherapy programme was less expensive (mean cost difference −£200; 95% confidence interval: −£656 to £255) and more effective (mean QALY difference 0.13; 95% confidence interval: 0.05 to 0.21) than standard physiotherapy and had a high probability of being cost-effective. Conclusion: From the National Health Service perspective, an accelerated physiotherapy programme for male patients undergoing revision of total hip arthroplasty (RHA) is very likely to be cost-effective when compared to a standard physiotherapy programme. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acupuncture in patients with vascular cognitive impairment no dementia (VCIND) in comparison with citicoline, an agent for cognitive disturbances associated with chronic cerebral disorders. Design: A randomized controlled multicenter trial. Setting: In three hospitals in Beijing, China. Subjects: A total of 216 patients with VCIND were recruited. Interventions: Patients with VCIND (mean age of 65.4 years) were randomized to receive acupuncture (two sessions per week) or oral citicoline (100 mg three times daily) over three months. Main measures: The primary outcome was the change from baseline to three months in cognitive symptom, measured by Alzheimer's disease Assessment Scale, cognitive subscale (ADAS-cog). Secondary outcomes included changes from baseline to six months in ADAS-cog, executive function measured by the Clock Drawing Test (CDT), and functional disability measured by the Ability of Daily Living (ADL) scale at three and six months. Results: At three months, the acupuncture group had a greater decrease in mean ADAS-cog score (−2.33 ± 0.31) than the citicoline group (−1.38 ± 0.34) with a mean difference of −0.95 (95% CI, −1.84 to −0.07, P = 0.035). The mean change from baseline to six months in ADAS-cog also significantly favored acupuncture treatments (acupuncture change −2.61 vs citicoline −1.25, difference: −1.36 points; 95% CI, −2.20 to −0.51; P = 0.002). There was no difference between the two groups on CDT and ADL scores at either time point. Conclusion: Compared with citicoline, acupuncture has comparable and even superior efficacy with improved cognitive and daily living performance as a complementary and alternative medicine treatment for VCIND. [ABSTRACT FROM AUTHOR]

Purpose: This research study aims to evaluate the effectiveness of a psychoeducation group, which is founded on an Eastern approach to health care, in improving the quality of life of Chinese people with mild cognitive impairment (PwMCI). Method: In a randomized controlled trial (RCT), 40 Chinese PwMCI were randomly assigned to either a 10-session psychoeducation group or the control group. Results: A paired sample t test indicated that the treatment group (n = 18) showed significant improvement in their World Health Organization Quality of Life Measure (WHOQOL) score, while the control group (n = 22) did not. Moreover, an independent t test showed that the treatment group was more effective than the control group to improve their WHOQOL score. A reduction in the depressive symptoms was related to the improvement in WHOQOL score. Conclusions: This RCT provides evidence to support the feasibility and effectiveness of psychoeducation groups for improving the overall quality of life of PwMCI. [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Objective: To determine the feasibility and short-term efficacy of caregiver-directed constraint-induced movement therapy to improve upper limb function in young children with hemiplegic cerebral palsy. Design: Randomized controlled trial with masked assessment. Setting: Community paediatric therapy services. Subjects: Pre-school children with hemiplegic cerebral palsy. Interventions: Caregiver-directed constraint-induced movement therapy administered using either 24-hour short-arm restraint device (prolonged) or intermittent holding restraint during therapy (manual). Main measures: Primary measures include Assisting Hand Assessment (AHA) at 10 weeks. Secondary measures include adverse events, Quality of Upper Extremity Skills Test and Pediatric Quality of Life Inventory. Feasibility measures include recruitment, retention, data completeness and adherence. Results: About 62/81 (72%) of eligible patients in 16 centres were randomized (prolonged restraint n = 30; manual restraint n = 32) with 97% retention at 10 weeks. The mean change at 10 weeks on the AHA logit-based 0–100 unit was 9.0 (95% confidence interval (CI): 5.7, 12.4; P < 0.001) for prolonged restraint and 5.3 (95% CI: 1.3, 9.4; P = 0.01) for manual restraint with a mean group difference of 3.7 (95% CI: −1.5, 8.8; P = 0.156) (AHA smallest detectable difference = 5 units). No serious related adverse events were reported. There were no differences in secondary outcomes. More daily therapy was delivered with prolonged restraint (60 vs 30 minutes; P < 0.001). AHA data were complete at baseline and 10 weeks. Conclusion: Caregiver-directed constraint-induced movement therapy is feasible and associated with improvement in upper limb function at 10 weeks. More therapy was delivered with prolonged than with manual restraint, warranting further testing of this intervention in a longer term trial. [ABSTRACT FROM AUTHOR]

Objective: Aim of this trial was to compare efficacy of activated platelet-rich plasma against hyaluronic acid as intra-articular injections to people with osteoarthritis of the knee. Design: Phase-2 randomized controlled trial, with blind patients and outcome assessors. Setting: Outpatient rehabilitation service; years 2011-2013. Subjects: Patients with knee osteoarthritis grades 2-3 at magnetic resonance imaging (MRI) were included after consent and randomized. Target sample size was 25 patients per group. Interventions: Patients received three activated platelet-rich plasma (intervention group) or hyaluronic acid (controls) intra-articular injections at 4-week intervals. Main measures: Main outcome measure was proportion of patients with >1 grade improvement at six months from last injection, as assessed by a radiologist blind to study group. Patients were evaluated over time clinically and with functional scales (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm, Tegner, American Knee Society Score (AKSS), Lequesne, visual analogue scale (VAS) for pain). Results: Overall, 30 patients were randomized to intervention and 28 to control group. For primary outcome, 28 patients (29 knees) in the intervention and 22 (25 knees) in the control group were available. Patients with at least 1 grade improvement at repeat MRI were 14 (48.3%) in the intervention and 2 (8%) in the control group (P < 0.003). Improvement in symptoms and functional scales was consistently higher in the intervention group. No side-effects were observed in either group. Conclusion: Activated platelet-rich plasma reduces articular damage as evident at MRI, as soon as six months after treatment; it reduces pain and improves patient's function and overall quality of life. [ABSTRACT FROM AUTHOR]

Background: The recommended initial treatment for multidirectional instability (MDI) of the shoulder is a rehabilitation program, yet there is very low-quality evidence to support this approach. Purpose/Hypothesis: The purpose was to compare the Watson MDI program and Rockwood Instability program among patients with nontraumatic, nonstructural MDI. The hypothesis was that the Watson MDI program would produce clinically and statistically superior outcomes over the Rockwood Instability program. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: Forty-one participants with MDI were randomly allocated to the Watson MDI or Rockwood Instability program. Participants attended 12 weekly physiotherapy sessions for exercise prescription. Outcomes were assessed at baseline and 6, 12, and 24 weeks after randomization. Primary outcomes were the Melbourne Instability Shoulder Score (MISS) and the Western Ontario Shoulder Index (WOSI). Secondary outcomes included the Orebro Musculoskeletal Pain Questionnaire, pain, muscle strength, scapular upward rotation, scapular coordinates, global rating of change, satisfaction scales, limiting angle in abduction range, limiting factor in abduction range, and incidence of dislocation. Primary analysis was by intention to treat based on linear mixed models. Results: Between-group differences showed significant effects favoring the Watson program for the WOSI (effect size [ES], 11.1; 95% CI, 1.9-20.2; P = .018) and for the limiting factor in abduction (ES, 0.1; 95% CI, 0.0-1.6; P = .023) at 12 weeks, and for the WOSI (ES, 12.6; 95% CI, 3.4-21.9; P =. 008), MISS (ES, 15.4; 95% CI, 5.9-24.8; P = .002), and pain (ES, -2.0; CI: -2.3 to -0.7, P = .003) at 24 weeks. Conclusion: For people with MDI, 12 sessions of the Watson MDI program were more effective than the Rockwood program at 12- and 24-week follow-up. Registration: ACTRN12613001240730 (Australian New Zealand Clinical Trials Registry). [ABSTRACT FROM AUTHOR]

Objective: To report on the control group of a trial primarily designed to investigate exercise for improving mobility in people with Parkinson’s disease (pwP). The control group undertook a handwriting intervention to control for attention and time spent practising a specific activity. Design: Secondary analysis of a two-arm parallel phase II randomized controlled trial with blind assessment. Setting: Community. Participants: PwP able to walk ⩾100 m and with no contraindication to exercise were recruited from the Thames Valley, UK, and randomized (1:1) to exercise or handwriting, via a concealed computer-generated list. Intervention: Handwriting was undertaken at home and exercise in community facilities; both were delivered through workbooks with monthly support visits and involved practice for 1 hour, twice weekly, over a period of six months. Main measures: Handwriting was assessed, at baseline, 3, 6 and 12 months, using a pangram giving writing speed, amplitude (area) and progressive reduction in amplitude (ratio). The Movement Disorder Society (MDS)–Unified Parkinson’s Disease Rating Scale (UPDRS) item 2.7 measured self-reported handwriting deficits. Results: In all, 105 pwP were recruited (analysed: n = 51 handwriting, n = 54 exercise). A total of 40 pwP adhered to the handwriting programme, most completing ⩾1 session/week. Moderate effects were found for amplitude (total area: d = 0.32; 95% confidence interval (CI): −0.11 to 0.7; P = 0.13) in favour of handwriting over a period of12 months; effects for writing speed and ratio parameters were small ≤0.11. Self-reported handwriting difficulties also favoured handwriting (UPDRS 2.7: odds ratio (OR) = 0.55; 95% CI: 0.34 to 0.91; P = 0.02). No adverse effects were reported. Conclusion: PwP generally adhere to self-directed home handwriting which may provide benefit with minimal risk. Encouraging effects were found in writing amplitude and, moreover, perceived ability. [ABSTRACT FROM AUTHOR]

Background: Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available. Purpose: To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)–guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures. Results: Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 (P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 (P = .32). There was total resorption in 62% of group 1 and 73% of group 2 (P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, –8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period (P < .001). Conclusion: No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry). [ABSTRACT FROM AUTHOR]

Introduction: Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Methods: Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word 'pilot' or 'feasibility' was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. Results: The specific purposes of piloting were stated in only 58% (n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Discussion: Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources. [ABSTRACT FROM AUTHOR]

Objective: To compare efficacy of a web-based multimodal training programme, ‘Move it to improve it’ (MitiiTM), to usual care on gross motor capacity and performance for children with an acquired brain injury. Design: Randomized waitlist controlled trial. Setting: Home environment. Participants: A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of MitiiTM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29). Intervention: The MitiiTM program comprised of gross motor, upper limb and visual perception/cognitive activities. Main measures: The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry. Results: Groups were equivalent at baseline on demographic and clinical measures. The MitiiTM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26–17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes. Conclusion: Although the MitiiTM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury. Clinical Trial Registration: Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of a group-based multidisciplinary rehabilitation programme on disability, pain and quality of life in subjects with chronic neck pain. Design: Randomized controlled trial. Setting: Specialized rehabilitation centre. Subjects: A total of 170 patients (mean age of 53 years (13); 121 females). Interventions: The multidisciplinary group underwent a multidisciplinary rehabilitation programme combining multimodal exercises with psychologist-lead cognitive-behavioural therapy sessions. The general exercise group underwent general physiotherapy. Both groups followed group-based programmes once a week for ten weeks. Additionally, the multidisciplinary group met with the psychologist once a week for a 60-minute session. Main measures: The Neck Disability Index (primary outcome), the Tampa Scale for Kinesiophobia, the Pain Catastrophizing Scale, a pain numerical rating scale and the Short-Form Health Survey. The participants were evaluated before, after training and after 12 months. Results: A linear mixed model for repeated measures was used for each outcome measure. Significant effects (p-value <0.001) were found over time and between groups for all outcome measures. After training, significant improvements were found for both groups for all outcome measures except kinesiophobia and catastrophizing, which did not change in the control group; however, the improvements were significantly greater for the multidisciplinary group. At 12-month follow-up a clinically meaningful between-group difference of 12.4 Neck Disability Index points was found for disability. Conclusions: A group-based multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to group-based general physiotherapy in improving disability, pain and quality of life of subjects with chronic neck pain. The effects lasted for at least one year. [ABSTRACT FROM AUTHOR]

Improving early detection and treatment of atrial fibrillation (AF) is critical because untreated AF is a major contributor to stroke and heart failure. We sought to generate knowledge about the feasibility of conducting a randomized controlled trial to test the effect of the Alert for AFib intervention on knowledge, attitudes, and beliefs about treatment-seeking for signs and symptoms of AF. Adults ≥65 years old (96% White) at risk for developing AF were randomized to receive the Alert for AFib intervention (n = 40) or an attention control session (n = 40). Feasibility goals for recruitment, participant retention, adherence, perceived satisfaction and burden, and intervention fidelity were met. From baseline to study completion, knowledge (p = .005) and attitudes (p < .001) about treatment-seeking improved more in the intervention group compared with the control group. Results support testing the effectiveness of the Alert for AFib intervention in a large trial. [ABSTRACT FROM AUTHOR]

Objective: To assess the feasibility of Wii.n.Walk for improving walking capacity in older adults with lower limb amputation. Design: A parallel, evaluator-blind randomized controlled feasibility trial. Setting: Community-living. Participants: Individuals who were ⩾50 years old with a unilateral lower limb amputation. Intervention: Wii.n.Walk consisted of Wii Fit training, 3x/week (40 minute sessions), for 4 weeks. Training started in the clinic in groups of 3 and graduated to unsupervised home training. Control group were trained using cognitive games. Main Measures: Feasibility indicators: trial process (recruitment, retention, participants’ perceived benefit from the Wii.n.Walk intervention measured by exit questionnaire), resources (adherence), management (participant processing, blinding), and treatment (adverse event, and Cohen’s d effect size and variance). Primary clinical outcome: walking capacity measured using the 2 Minute Walk Test at baseline, end of treatment, and 3-week retention. Results: Of 28 randomized participants, 24 completed the trial (12/arm). Median (range) age was 62.0 (50-78) years. Mean (SD) score for perceived benefit from the Wii.n.Walk intervention was 38.9/45 (6.8). Adherence was 83.4%. The effect sizes for the 2 Minute Walk Test were 0.5 (end of treatment) and 0.6 (3-week retention) based on intention to treat with imputed data; and 0.9 (end of treatment) and 1.2 (3-week retention) based on per protocol analysis. The required sample size for a future larger RCT was deemed to be 72 (36 per arm). Conclusions: The results suggested the feasibility of the Wii.n.Walk with a medium effect size for improving walking capacity. Future larger randomized controlled trials investigating efficacy are warranted. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of a group-based self-management program for people with chronic fatigue syndrome. Design: A randomized controlled trial. Setting: Four mid-sized towns in southern Norway and two suburbs of Oslo. Subjects: A total of 137 adults with chronic fatigue syndrome. Intervention: A self-management program including eight biweekly meetings of 2.5 hours duration. The control group received usual care. Main measures: Primary outcome measure: Medical Outcomes Study-Short Form-36 physical functioning subscale. Secondary outcome measures: Fatigue severity scale, self-efficacy scale, physical and mental component summary of the Short Form-36, and the illness cognition questionnaire (acceptance subscale). Assessments were performed at baseline, and at six-month and one-year follow-ups. Results: At the six-month follow-up, a significant difference between the two groups was found concerning fatigue severity (p = 0.039) in favor of the control group, and concerning self-efficacy in favor of the intervention group (p = 0.039). These significant differences were not sustained at the one-year follow-up. No significant differences were found between the groups concerning physical functioning, acceptance, and health status at any of the measure points. The drop-out rate was 13.9% and the median number of sessions attended was seven (out of eight). Conclusions: The evaluated self-management program did not have any sustained effect, as compared with receiving usual care. [ABSTRACT FROM AUTHOR]

We evaluated a cognitive behaviour therapy–based programme to improve glycaemic control and psychosocial wellbeing in adolescents with type 1 diabetes. A total of 147 adolescents aged 13–16 years were randomized to the intervention (n = 73) or standard care (n = 74). The primary outcome was glycaemic control at 3 and 12 months post randomization, and secondary measures were stress, self-efficacy and quality of life. Mixed-effects regression models were used to assess differences in means between groups at each time point. There was little evidence of differences in glycaemic control between groups. However, psychosocial wellbeing improved in the intervention group compared to the control group. Recommendations for future programmes are discussed. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000368336). [ABSTRACT FROM AUTHOR]

Objective: To enhance participation post stroke through a structured, community-based program. Design: A controlled trial with random allocation to immediate or four-month delayed entry. Setting: Eleven community sites in seven Canadian cities. Subjects: Community dwelling persons within five years of stroke onset, cognitively intact, able to toilet independently. Interventions: Evidence-based program delivered in three 12-week sessions including exercise and project-based activities, done as individuals and in groups. Main measures: Hours spent per week in meaningful activities outside of the home and Reintegration to Normal Living Index; Stroke-Specific Geriatric Depression Scale, Apathy Scale, gait speed, EuroQuol EQ-5D, and Preference-Based Stroke Index. All measures were transformed to a scale from 0 to 100. Assessments prior to randomization, after the first session at three months, six months, 12 months, and 15 months. Results: A total of 186 persons were randomized. The between-group analysis showed no disadvantage to waiting and so groups were combined and a within-person analysis was carried out at three time points. There were statistically significant increases in all study outcomes on average over all persons. Over 45% of people met or exceeded the pre-specified target of a three hour per week increase in meaningful activity and this most often took a full year of intervention to achieve. Greatest gains were in satisfaction with community integration (mean 4.78; 95% CI: 2.01 to 7.55) and stroke-specific health-related quality of life (mean 4.14; 95% CI: 2.31 to 5.97). Conclusions: Community-based programs targeting participation are feasible and effective, but stroke survivors require time to achieve meaningful gains. [ABSTRACT FROM AUTHOR]