Search

Objective: This study aimed to assess if external focus instructions result in greater improvements in motor skill and automaticity compared to internal focus instructions in stroke patients. Design: Double-blind randomized controlled trial. Setting: Inpatient stroke rehabilitation unit. Subjects: A total of 63 stroke patients (Meanage = 59.6 ± 10.7 years; Meandays since stroke = 28.5 ± 16.6; MedianFunctional Ambulation Categories = 4). Interventions: Patients were randomly assigned to an internal (N = 31) or external (N = 32) focus instruction group. Both groups practiced a balance board stabilization task, three times per week, for three weeks. Balance performance was assessed at baseline, and after one and three weeks of practice. Main measures: Primary outcome was the threshold stiffness (Nm/rad) at which patients could stay balanced. Secondary outcomes were patients' sway (root-mean-square error in degrees) at the baseline threshold stiffness under single- and dual-task conditions, and their performance on the Timed Up and Go Test and Utrecht Scale for Evaluation of Rehabilitation. Results: Both groups achieved similar improvements in threshold stiffness (∆= 27.1 ± 21.1 Nm/rad), and single- (∆= 1.8 ± 2.3° root-mean-square error) and dual-task sway (∆= 1.7 ± 2.1° root-mean-square error) after three weeks of practice. No differences were found in improvements in clinical tests of balance and mobility. Patients with comparatively good balance and sensory function, and low attention capacity showed greatest improvements with external focus instructions. Conclusion: External focus instructions did not result in greater improvement in balance skill in stroke patients compared to internal focus instructions. Results suggest that tailoring instructions to the individual stroke patient may result in optimal improvements in motor skill. [ABSTRACT FROM AUTHOR]

Two blinded single-dose studies randomized children 6 months to 11 years old with fever to receive ibuprofen (IBU) pediatric suspension 7.5 mg/kg or acetaminophen (APAP) suspension 10 to 15 mg/kg. The primary efficacy parameter was time-weighted sum of temperature differences (TWSTD) from baseline through 8 hours for each study. Secondary end points included TWSTD from baseline through 6 hours, time to onset and duration of temperature control, and proportion with temperature control. Studies were pooled for post hoc analyses of efficacy and adverse event end points. The primary efficacy parameter significantly favored IBU over APAP in study 1 and the pooled analysis (both P < .001), but was not significant in study 2. Onset of temperature control significantly favored IBU in study 2 (P = .007). Individual and pooled secondary efficacy outcomes supported significant advantages (P < .05) of IBU over APAP. IBU pediatric suspension provided greater temperature reduction versus acetaminophen in febrile children, with a comparable safety profile. [ABSTRACT FROM AUTHOR]

Background: Achilles tendinopathy (AT) is a common and difficult to treat musculoskeletal disorder. Purpose: To examine whether 1 injection of platelet-rich plasma (PRP) would improve outcomes more effectively than placebo (saline) after 3 months in patients with AT. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 24 patients with chronic AT (median disease duration, 33 months) were randomized (1:1) to receive either a blinded injection of PRP (n = 12) or saline (n = 12). The primary endpoint was improvement in Victorian Institute of Sports Assessment–Achilles (VISA-A) score at 3 months. Secondary outcomes were pain at rest, pain while walking, pain when tendon was squeezed, ultrasonographic changes in tendon thickness, and color Doppler activity. Patients were informed that they could drop out after 3 months if they were dissatisfied with the treatment. Results: After 3 months, all 24 patients were reassessed (no dropouts). No difference between the PRP and the saline group could be observed with regard to the primary outcome (VISA-A score: mean difference [MD], –1.3; 95% CI, −17.8 to 15.2; P = .868). Secondary outcomes were pain at rest (MD, 1.6; 95% CI, −0.5 to 3.7; P = .137), pain while walking (MD, 0.8; 95% CI, −1.8 to 3.3; P = .544), pain when tendon was squeezed (MD, 0.3; 95% CI, −0.2 to 0.9; P = .208), color Doppler activity (MD, 0.3; 95% CI, −0.2 to 0.8; P = .260), and tendon thickness (MD, 0.8 mm; 95% CI, 0.1 to 1.6 mm; P = .030). After the 3-month follow-up, a large dropout was observed: 75% of patients in the PRP group and 33% in the saline group. Conclusion: PRP injection did not result in an improved VISA-A score over a 3-month period in patients with chronic AT compared with placebo. The only secondary outcome demonstrating a statistically significant difference between the groups was change in tendon thickness; this difference indicates that a PRP injection could increase tendon thickness compared with saline injection. The conclusions are limited to the 3 months after treatment owing to the large dropout rate. [ABSTRACT FROM AUTHOR]

Background: Evidence from preclinical and human studies indicates the presence of reduced dopamine-1 receptor (D1R) signaling in the cortex, where D1Rs predominate, in patients with schizophrenia (SCZ), which may contribute to their cognitive deficits. Furthermore, studies in nonhuman primates (NHP) have suggested that intermittent administration of low doses of D1R agonists produce long-lasting reversals in cognitive deficits. The purpose of this trial was to test whether a similar design, involving subacute intermittent administration of low doses of a full, selective agonist at D1Rs, DAR-0100A, would improve cognitive deficits in SCZ.Methods: We randomized 49 clinically stable individuals with SCZ to three weeks of intermittent treatment with 0.5 mg or 15 mg of DAR-0100A, or placebo (normal saline). Functional magnetic resonance imaging (fMRI) BOLD was used to evaluate the effects of drug administration on brain activity during a working memory (WM) task. Effects on cognition were also assessed using the MATRICS and the N-back task as primary endpoints. The CogState battery was used as a secondary endpoint.Results: There were no observed treatment effects on either the BOLD fMRI signal during WM tasks or the WM domains of the MATRICS. Moderate improvement was detected on the CogState battery and on the attention domain of the MATRICS.Conclusion: These results suggest that low doses of D1 agonists that do not result in measureable occupancy of the D1R do not reliably improve cognition in SCZ, unlike the observations in NHP. As this drug is limited by its pharmacokinetic profile, better D1R agonists that can achieve adequate levels of D1R occupancy are needed to test the efficacy of this mechanism for cognitive enhancement in SCZ. [ABSTRACT FROM AUTHOR]

Background. Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown. Methods. In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 109 colony forming units per day), or high-dose (8 × 109 colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism. Results. The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI −14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose. Conclusions. The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required. [ABSTRACT FROM AUTHOR]

The article focuses on a randomized, single-blind study which investigates the effectiveness of Wii Sports Resort™ training and if they possess benefits. Topics include consideration of hemiplegic children with cerebral palsy for study, health benefits of regular participation in physical activity, people with cerebral palsy and virtual reality as a training tool that encourages ability to prescribe the dose of exercise.

The role of cholinergic abnormalities in autism was recently evidenced and there is a growing interest in cholinergic modulation, emerging for targeting autistic symptoms. Galantamine is an acetylcholinesterase inhibitor and an allosteric potentiator of nicotinic receptors. This study aimed to evaluate the possible effects of galantamine as an augmentative therapy to risperidone, in autistic children. In this randomized, double-blind, placebo-controlled, parallel-group study, 40 outpatients aged 4–12 years whom had a diagnosis of autism (DSM IV-TR) and a score of 12 or higher on the Aberrant Behavior Checklist-Community (ABC-C) Irritability subscale were equally randomized to receive either galantamine (up to 24 mg/day) or placebo, in addition to risperidone (up to 2 mg/day), for 10 weeks. We rated participants by ABC-C and a side effects checklist, at baseline and at weeks 5 and 10. By the study endpoint, the galantamine-treated patients showed significantly greater improvement in the Irritability (P = 0.017) and Lethargy/Social Withdrawal (P = 0.005) subscales than the placebo group. The difference between the two groups in the frequency of side effects was not significant. In conclusion, galantamine augmentation was shown to be a relatively effective and safe augmentative strategy for alleviating some of the autism-related symptoms. [ABSTRACT FROM PUBLISHER]

The article focuses on the study which aims to evaluate the effectiveness and efficiency between the robot-assisted arm group therapy (RAGT) and individual arm therapy (IAT) to restore motor function in severely affected patients after stroke. It states that patients improved their upper limb motor function over time. It mentions that the RAGT in combination with IAT was effective in restoring upper limb motor functions.

The article presents the study which examined the effectiveness of platelet-rich plasma (PRP) as a treatment for patellar tendinopathy. Among the measures used in the study are the Victorian Institute of Sports Assessment (VISA) score for patellar tendinopathy, the visual analog scale (VAS) for pain, and the Tegner activity scale. Based on the results, the apparent benefits of PRP as treatment dissipate over time.

The article reports a study to evaluate whether a single injection of platelet-rich plasma (PRP) is more effective than placebo (saline) or glucocorticoid in reducing pain in adults with lateral epicondylitis (LE) after 3 months. The results proved that neither PRP nor glucocorticoid was superior to saline in pain reduction in LE at the primary end point at 3 months. However, injection of glucocorticoid had a short-term pain reducing effect at 1 month in contrast to the other therapies.

The article discusses a study conducted to examine the safety and efficacy of onabotulinumtoxinA (Botox) for plantarflexor overactivity following stroke. It highlights that Botulinum toxin type A (BoNT-A) is treatment of choice to reduce the neurogenic component of focal hypertonia; and leads to muscle overactivity causing equinovarus ankle deformity after stroke. The result suggests that its injection for ankle flexor overactivity after stroke was safe but did not alter local spasticity.

Background: The authors developed a novel technique to improve tendon-bone healing by hybridizing calcium phosphate (CaP) with a tendon graft using an alternating soaking process. Hypothesis: Anterior cruciate ligament (ACL) reconstruction using the CaP-hybridized tendon graft would have a better clinical outcome and reduce the percentage of bone tunnel enlargement compared with a conventional method because of the enhanced anchoring between the tendon graft and the bone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients (N = 64) with unilateral ACL rupture underwent arthroscopically assisted single-bundle ACL reconstruction using a 4-strand semitendinosus tendon or 4-strand semitendinosus and gracilis tendons with EndoButton femoral fixation and screw washer tibial fixation. These patients were equally randomized to undergo the CaP (n = 32) or conventional (n = 32) method using a transtibial tunnel approach according to the closed envelope method. In the CaP group, the tendon graft was hybridized with the CaP at both ends of the graft. One surgeon performed all reconstructions without knowing which graft was prepared. Patients’ backgrounds regarding age at surgery, gender, period before surgery, and associated meniscal injuries were similar in the 2 groups. All patients followed the same postoperative protocol. At 1 and 2 years after surgery, they were evaluated with the manual knee laxity test, KT-1000 arthrometry, International Knee Documentation Committee (IKDC) examination form, Tegner scale, and Lysholm scale. Also, 1 year postoperatively, bone tunnel enlargement was analyzed using computed tomography, intensity of the tendon graft by magnetic resonance imaging (MRI), and tendon graft appearance by arthroscopic examination. All the examinations were performed blindly. Results: All patients underwent a minimum 2-year follow-up. KT-1000 arthrometry data indicated statistically significant decreased average anterior tibial translation in the CaP group compared with the conventional method group: 1.0 6 2.0 mm versus 1.9 6 1.6 mm (P\.05), respectively, at 1 year; 1.6 6 2.1 mm versus 2.6 6 2.4 mm (P\.05), respectively, at 2 years. The Lysholm score was higher in the CaP group than in the conventional method group at 2 years (96.9 6 4.3 vs 91.7 6 13.3, P\.05). The CaP-hybridized tendon graft reduced the percentage of bone tunnel enlargement of the anteroposterior diameter at the main joint aperture site 1 year postoperatively (femoral side: 15.5% 6 13.4% vs 22.1% 6 16.4%, P\.05; tibial side: 19.3% 6 17.1% vs 26.1% 6 13.7%, P\.05). The results of the pivot-shift test, IKDC grade, and Tegner score; the intensity of the tendon graft (MRI); and arthroscopic appearance were not significantly different at both follow-up periods in the 2 groups. Conclusion: The CaP-hybridized tendon graft improved anterior knee stability and Lysholm scores at the 2-year follow-up and improved anterior knee stability and reduced the percentage of bone tunnel enlargement in both tunnels at the 1-year follow-up compared with the conventional method for single-bundle ACL reconstruction. However, longer follow-up is needed to investigate the appearance of any increased instability. [ABSTRACT FROM AUTHOR]

Objective: Adults with long-term neurological conditions have low levels of participation in physical activities and report many barriers to participation in exercise. This study examines the feasibility and safety of supporting community exercise for people with long-term neurological conditions using a physical activity support system.Design: A phase II randomized controlled trial using computer-generated block randomization, allocation concealment and single blind outcome assessment.Setting: Oxfordshire and Birmingham community Inclusive Fitness Initiative gyms.Subjects: Patients with a long-term neurological condition.Interventions: The intervention group (n = 51) received a 12-week, supported exercise programme. The control group (n = 48) participants received standard care for 12 weeks and were then offered the intervention.Main measures: Physical activity, adherence to exercise, measures of mobility, health and well-being.Results: Forty-eight patients (n = 51) completed the intervention, achieving 14 gym attendances (range 0–39) over the 12 weeks. Overall activity did not increase as measured by the Physical Activity Scale for the Elderly (change score mean 14.31; 95% confidence interval (CI) −8.27 to 36.89) and there were no statistically significant changes in body function and health and well-being measures.Conclusions: People with long-term neurological conditions can safely exercise in community gyms when supported and achieve similar attendance to standard exercise referral schemes, but may reduce other life activities in order to participate at a gym. [ABSTRACT FROM PUBLISHER]

Objective: To test the efficacy of calcium dobesilate (CaD) in chronic venous insufficiency (CVI). Method: Double-blind, parallel groups, placebo-controlled, multicentre trial in adult patients with symptomatic CVI and pitting oedema. Wearing of compression stockings Class II was admitted. During treatment period of eight weeks, the patients received CaD 3 x 500 mg/day or placebo. The leg volume calculation was based on a truncated cone model. Results: A total of 256 patients was randomized to treatment (dobesilate: n = 132, placebo: n = 124); the demographic and anamnestic data at admission were comparable in the two therapeutic groups. The volume of the lower calf diminished in the dobesilate group at the end of the active treatment period by -64.72 ± 111.93 cm³ (mean ± SD), independent of the concomitant usage of compression stockings versus placebo +0.8 ± 152.98 cm³ (P = 0.0002). The symptoms of pain, discomfort, heavy legs, tired legs, tingling, itching and cramps, as well as the global assessments by investigators and patients, also improved significantly (P < 0.05) better in the dobesilate group at the end of the treatment. The observed adverse events correspond to the known profile. Conclusion: Dobesilate reduces leg oedema and improves the symptoms of objectively diagnosed CVI, independent of the concomitant usage of compression stockings. [ABSTRACT FROM AUTHOR]

Most people with episodic tension-type headache (TTH) treat themselves with over-the-counter analgesics. In the absence of clear evidence of dose-related efficacy of the two most commonly used analgesics, aspirin (acetylsalicylic acid) and paracetamol (acetaminophen), this study compared two doses of each with placebo. In a double-blind, double-dummy, randomized parallel-groups comparative trial, 638 consenting subjects aged 16-65 years with episodic TTH (but not migraine) by IHS criteria were recruited from the UK general population by advertisement. They treated one episode of moderate or severe TTH with a single dose of 500 or 1000 mg aspirin, 500 or 1000 mg paracetamol or placebo. The primary objective was to compare aspirin 1000 mg with placebo, and the primary end-point was subjective pain relief (total or worthwhile) 2 h after treatment ('response'). Additionally, pain intensity on a 100-mm visual analogue scale and functional impairment were monitored regularly for 4 h and at 24 h, although rescue medication was allowed after 2 h. The analysis was of the intention-to-treat population of 542 who took treatment (all providing outcome data). Treatment groups were matched at baseline. Aspirin 1000 mg (75.7% response rate; P = 0.0009) and to a lesser extent aspirin 500 mg (70.3%; P = 0.011) and paracetamol 1000 mg (71.2%; P = 0.007), but not paracetamol 500 mg (63.8%; P = 0.104), were statistically more effective than placebo despite a high placebo-response rate (54.5%). Outcome was not affected by headache intensity at baseline. Secondary end-points including functional recovery (by median times of 4.0-13.5 h) were consistent with these findings, although a minority of subjects recorded long-duration functional impairment (37-54 h). Adverse events reported by 13.4-18.9% of subjects were mild or moderate, and transient. No safety concerns arose. [ABSTRACT FROM AUTHOR]

S-fluoxetine is the long-acting enantiomer of the racemic antidepressant serotonin reuptake inhibitor. Sixty-five patients needing migraine prophylaxis were recruited into a phase II, double-blind, placebo-controlled trial. After a 1-month placebo run-in, 53 patients met entry criteria with regard to attack frequency and were randomized, 27 to S-fluoxetine and 26 to matching placebo. Three failed to start treatment and there were 17 early discontinuations, 9 from S-fluoxetine, 8 from placebo, at similar times and for similar reasons. The primary efficacy variable was attack frequency and analysis compared decline-from-baseline in the two groups. This was earlier and greater (1.7 attacks/28 days, or 52%) on active therapy than on placebo (1.1 attacks/28 days, or 27%), and statistically significant in month 2 (F = 4.93; p = 0.033) and month 4 (F = 4.55; p = 0.041). As secondary measures of efficacy, migraine-days per month and Patient's Global Impression of Disease Severity coherently reflected the changes in attack frequency. Mean attack severity and acute medication use (doses per attack) were unaltered by either treatment. There were no serious adverse events. Withdrawals for adverse events were four from each group but none was considered causally related. The finding of greater efficacy of S-fluoxetine than of placebo should be interpreted conservatively, since the analysis in the final month was made on only half of the entered patients. It supports progression to phase III evaluation, which was the purpose of the study. [ABSTRACT FROM AUTHOR]

Alniditan is a new 5HT1D receptor agonist, belonging to a different chemical class from sumatriptan and other indole derivatives used or being developed for the treatment of acute migraine. In a multinational double-blind randomized parallel-groups dose-finding trial, alniditan was given subcutaneously in hospital to patients with migraine headache of moderate or severe intensity at doses of 0.8 mg (n = 44), 1.0 mg (n = 42), 1.2 mg (n = 46) and 1.4 mg (n = 39). Efficacy, tolerability and safety of each dose were compared with those of placebo (n = 41). At 2 h after injection, headache was absent or mild in 83% and 82% of patients receiving alniditan 1.2 and 1.4 mg respectively compared with 39% for placebo (p < or = 0.002). Complete relief from headache was achieved in 72% (1.4 mg). Time to onset of relief decreased with increasing alniditan dose, and there was a dose-dependent reduction in headache recurrence rate: 25% of patients receiving 1.4 mg had responded by 15 min and headache recurred within 24 h in only 16% of the patients who initially responded to alniditan 1.4 mg, significantly less than for placebo (p = 0.018). Alniditan was superior to placebo in reducing the associated symptoms of nausea, phonophobia and photophobia, and in increasing patients' functional ability. The use of rescue medication was reduced when compared with placebo, and up to 87% of patients said that they would use the drug again if available. No clinically relevant cardiovascular effects were seen, nor consistent changes in clinical laboratory findings. Adverse effects, mainly head pressure, paraesthesia, and hot flushes, were reported by 34% of placebo-treated patients and up to 70% of patients receiving alniditan, but all doses were very well tolerated and no clear relationship with dose was established. Comparison with published findings suggests that alniditan 1.4 mg sc may have advantages over sumatriptan 6 mg sc in providing complete relief from acute migraine headache, and may be associated with fewer headache recurrences within 24 h. Both of these suggestions warrant further and larger trials of alniditan in acute migraine. [ABSTRACT FROM AUTHOR]