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Italy has been one of the first-hit and most affected countries worldwide by the coronavirus disease 2019 (COVID-19) outbreak, and Lombardy accounts for almost half of all Italian cases. Vulnerable population is the one suffering the most from the current epidemic, without guaranteed access to basic needs. This aspect becomes critical for people experiencing disability, either due or not to COVID-19. To face the pandemic, all the regional health system services, rehabilitation ones included, were forced to radically adapt their operating paradigm and even sometimes to leave their intrinsic mission. The Italian Society of Physical and Rehabilitation Medicine (SIMFER) since the beginning of the outbreak was profoundly involved in the clinical and organizational response to COVID-19. The Lombardy regional group cooperated strictly and continuously with the national group to coordinate rehabilitation processes region wide. The paper presents a brief report of our field experience describing the phases faced since the beginning of the pandemic and suggesting the organizational strategies that could be useful in rehabilitation services for both inpatients and outpatients. Springing from literature and the experience of the Lombardy section of SIMFER, this paper should help clinicians to respond to the need of the disabled patient facing the new COVID-19 outbreak.

OBJECTIVES: The aim of this study was to compare the impact of fast-track rehabilitation (FTR) and conventional rehabilitation (CR) on early recovery pattern after fast-track surgery for knee arthroplasty and conventional total knee arthroplasty (TKA). PATIENTS AND METHODS: This prospective, case-control study included a total of 43 adult patients (10 males, 33 females; mean age 69 years; range, 50 to 82 years) who were clinically stable and admitted for rehabilitation after fast-track surgery for knee arthroplasty or conventional TKA January 2016 and August 2016. The patients were divided into two groups as the FTR and CR treatment groups. The FTR program was designed as a patient-focused care, early mobilization, and standardized postoperative milestones. The CR program was designed by standard postoperative rehabilitation care. Primary outcomes were the length of stay (LOS) in the hospital and knee function. Secondary outcomes were pain and activities of daily living. RESULTS: At baseline, both groups were similar in terms of demographic data and primary outcomes. At discharge, intra-group analysis showed significant differences in both groups in all functional outcomes, except for pain, while the inter-group LOS was also significantly different (p

DETAILS OF THE CLINICAL CASE: A 51-yr-old man underwent a respiratory rehabilitation program (RRP), after being tracheostomized and ventilated due to acute respiratory distress syndrome (ARDS) from coronavirus disease-2019 (COVID-19) infection. Respiratory care, early mobilization, and neuromuscular electrical stimulation were started in the ad hoc isolation ward of our rehabilitation center. At baseline, muscle function was consistent with intensive care unit-acquired weakness and the patient still needed mechanical ventilation (MV) and oxygen support. During the first week of RRP in isolation, the patient was successfully weaned from MV, the tracheal cannula was removed, and the walking capacity was recovered. At the end of the RRP, continued in a standard department, respiratory muscles strength increased by 7% and muscle function improved as indicated by the quadriceps size enlargement of 13% and the change of the Medical Research Council sum score from 48/60 to 58/60. DISCUSSION: Providing RRP in patients with severe COVID-19 ARDS involves risks for operators and organizational difficulties, especially in rehabilitation centers; nevertheless, its continuity is important to prevent the development of permanent disabilities in previously healthy subjects. Limited to the experience of only one patient, we were able to carry out a safe RRP during the COVID-19 pandemic, promoting the complete functional recovery of a COVID-19 young patient. SUMMARY: Most patients who develop serious consequences of COVID-19 infection risk a reduction in their quality of life. However, by organizing and directing specialized resources, subacute rehabilitation facilities could ensure the continuity of the RRPs even during the COVID-19 pandemic.

BACKGROUND: Gait impairments are common disabling symptoms of Parkinson’s disease (PD). Among the approaches for gait rehabilitation, interest in robotic devices has grown in recent years. However, the effectiveness compared to other interventions, the optimum amount of training, the type of device, and which patients might benefit most remains unclear. OBJECTIVE: To conduct a systematic review about the effects on gait of robot-assisted gait training (RAGT) in PD patients and to provide advice for clinical practice. METHODS: A search was performed on PubMed, Scopus, PEDro, Cochrane library, Web of science, and guideline databases, following PRISMA guidelines. We included English articles if they used a robotic system with details about the intervention, the parameters, and the outcome measures. We evaluated the level and quality of evidence. RESULTS: We included twenty papers out of 230 results: two systematic reviews, 9 randomized controlled trials, 4 uncontrolled studies, and 5 descriptive reports. Nine studies used an exoskeleton device and the remainders end-effector robots, with large variability in terms of subjects’ disease-related disability. CONCLUSIONS: RAGT showed benefits on gait and no adverse events were recorded. However, it does not seem superior to other interventions, except in patients with more severe symptoms and advanced disease.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), resulting in coronavirus disease 2019 (COVID-19), has caused a pandemic. There is now considerable evidence that neuropsychological functions could be affected. We further tested this hypothesis on a sample of post COVID-19 patients, who, initially, had been severely affected.METHODS: We tested 22 post COVID-19 patients who, after the intensive care unit, were submitted to our rehabilitation unit to be treated for severe post COVID-19 sequelae. All patients were assessed with a comprehensive neuropsychological battery including measures assessing perceptual, attentive, mnestic, linguistic, and executive functions, and overall cognitive status. The patients were also administered rehabilitation measures including scales for investigating aerobic capacity/endurance deficits, dyspnea, and fatigue. RESULTS: Our findings revealed that evidence of neuropsychological disorders on post COVID-19 patients was very limited. Furthermore, COVID-19 severity and other relevant variables were not correlated with patients’ scores on the neuropsychological tests. CONCLUSIONS: We suggest that the relation between COVID-19 and neuropsychological disorders is unclear. New studies and metanalyses are highly required to shed light on this highly complex issue.

The upper extremities limitation represents one of the essential functional impairments in patients with cervical spinal cord injury. Electromechanics assisted devices and robots are increasingly used in neurorehabilitation to help functional improvement in patients with neurological diseases. This review aimed to systematically report the evidence-based, state-of-art on clinical applications and robotic-assisted arm training (RAT) in motor and functional recovery in subjects affected by cervical spinal cord injury. The present study has been carried out within the framework of the Italian Consensus Conference on “Rehabilitation assisted by robotic and electromechanical devices for persons with disability of neurological origin” (CICERONE). PubMed/MEDLINE, Cochrane Library, and Physiotherapy Evidence Database (PEDro) databases were systematically searched from inception to September 2021. The 10-item PEDro scale assessed the study quality for the RCT and the AMSTAR-2 for the systematic review. Two different authors rated the studies included in this review. If consensus was not achieved after discussion, a third reviewer was interrogated. The five-item Oxford CEBM scale was used to rate the level of evidence. A total of 11 studies were included. The selected studies were: two systematic reviews, two RCTs, one parallel-group controlled trial, one longitudinal intervention study and five case series. One RCT was scored as a high-quality study, while the systematic review was of low quality. RAT was reported as feasible and safe. Initial positive effects of RAT were found for arm function and quality of movement in addition to conventional therapy. The high clinical heterogeneity of treatment programs and the variety of robot devices could severely affect the generalizability of the study results. Therefore, future studies are warranted to standardize the type of intervention and evaluate the role of robotic-assisted training in subjects affected by cervical spinal cord injury.

INTRODUCTION: There is growing evidence on the efficacy of gait robotic rehabilitation in patients with multiple sclerosis (MS), but most of the studies have focused on gait parameters. Moreover, clear indications on the clinical use of robotics still lack. As part of the CICERONE Italian Consensus on Robotic Rehabilitation, the aim of this systematic review was to investigate the existing evidence concerning the role of lower limb robotic rehabilitation in improving functional recovery in patients with MS. EVIDENCE ACQUISITION: We searched for and systematically reviewed evidence-based studies on gait robotic rehabilitation in MS, between January 1st, 2010 and December 31st, 2020, in the following databases: Cochrane Library, PEDro, PubMed and Google Scholar. The study quality was assessed by the 16-item assessment of multiple systematic reviews 2 (AMSTAR 2) and the 10-item PEDro scale for the other research studies. EVIDENCE SYNTHESIS: After an accurate screening, only 17 papers were included in the review, and most of them (13 RCT) had a level II evidence. Most of the studies used the Lokomat as a grounded robotic device, two investigated the efficacy of end-effectors and two powered exoskeletons. Generally speaking, robotic treatment has beneficial effects on gait speed, endurance and balance with comparable outcomes to those of conventional treatments. However, in more severe patients (EDSS >6), robotics leads to better functional outcomes. Notably, after gait training with robotics (especially when coupled to virtual reality) MS patients also reach better non-motor outcomes, including spasticity, fatigue, pain, psychological well-being and quality of life. Unfortunately, no clinical indications emerge on the treatment protocols. CONCLUSIONS: The present comprehensive systematic review highlights the potential beneficial role on functional outcomes of the lower limb robotic devices in people with MS. Future studies are warranted to evaluate the role of robotics not only for walking and balance outcomes, but also for other gait-training-related benefits, to identify appropriate outcome measures related to a specific subgroup of MS subjects' disease severity.

Purpose: SARS-CoV-2 infection can cause the coronavirus disease (COVID), ranging from flu-like symptoms to interstitial pneumonia. Mortality is high in COVID pneumonia and it is the highest among the frailest. COVID could be particularly serious in patients with severe acquired brain injury (SABI), such as those with a disorder of consciousness. We here describe a cohort of patients with a disorder of consciousness exposed to SARS-CoV-2 early after their SABI.Materials and methods: The full cohort of 11 patients with SABI hospitalized in March 2020 in the IRCCS Fondazione Don Gnocchi rehabilitation (Milan, Italy) was recruited. Participants received SARS-CoV-2 testing and different clinical and laboratory data were collected.Results: Six patients contracted SARS-CoV-2 and four of them developed the COVID. Of these, one patient had ground-glass opacities on the chest CT scan, while the remaining three developed consolidations. No patient died and the overall respiratory involvement was mild, requiring in the worst cases low-flow oxygen.Conclusions: Here we report the clinical course of a cohort of patients with SABI exposed to SARS-CoV-2. The infection spread among patients and caused COVID in some of them. Unexpectedly, COVID was moderate, caused at most mild respiratory distress and did not result in fatalities.

In the last two decades, a growing interest has been focused on gait and balance robot-assisted rehabilitation in children with neurological disabilities. Robotic devices allow the implementation of intensive, task-specific training fostering functional recovery and neuroplasticity phenomena. However, limited attention has been paid to the protocols used in this research framework. This systematic review aims to provide an overview of the existing literature on robotic systems for the rehabilitation of gait and balance in children with neurological disabilities and their rehabilitation applications. The literature search was carried out independently and synchronously by three authors on the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, ScienceDirect, and Google Scholar. The data collected included three subsections referring to clinical, technical, and regulatory aspects. Thirty-one articles out of 81 found on the primary literature search were included in the systematic review. Most studies involved children with cerebral palsy. Only one-third of the studies were randomized controlled trials. Overall, 17 devices (nine end-effector systems and eight exoskeletons) were investigated, among which only 4 (24%) were bore the CE mark. Studies differ on rehabilitation protocols duration, intensity, and outcome measures. Future research should improve both rehabilitation protocols’ and devices’ descriptions.

Introduction The rapid development of electromechanical and robotic devices has profoundly influenced neurorehabilitation. Growth in the scientific and technological aspects thereof is crucial for increasing the number of newly developed devices, and clinicians have welcomed such growth with enthusiasm. Nevertheless, improving the standard for the reporting clinical, technical, and normative aspects of such electromechanical and robotic devices remains an unmet need in neurorehabilitation. Accordingly, this study aimed to analyse the existing literature on electromechanical and robotic devices used in neurorehabilitation, considering the current clinical, technical, and regulatory classification systems. Evidence acquisition Within the CICERONE Consensus Conference framework, studies on electromechanical and robotic devices used for upper- and lower-limb rehabilitation in persons with neurological disabilities in adulthood and childhood were reviewed. We have conducted a literature search using the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, Science Direct, and Google Scholar. Clinical, technical, and regulatory classification systems were applied to collect information on the electromechanical and robotic devices. The study designs and populations were investigated. Evidence synthesis Overall, 316 studies were included in the analysis. More than half (52%) of the studies were randomised controlled trials (RCTs). The population investigated the most suffered from strokes, followed by spinal cord injuries, multiple sclerosis, cerebral palsy, and traumatic brain injuries. In total, 100 devices were described; of these, 19% were certified with the CE mark. Overall, the main type of device was an exoskeleton. However, end-effector devices were primarily used for the upper limbs, whereas exoskeletons were used for the lower limbs (for both children and adults). Conclusions The current literature on robotic neurorehabilitation lacks detailed information regarding the technical characteristics of the devices used. This affects the understanding of the possible mechanisms underlying recovery. Unfortunately, many electromechanical and robotic devices are not provided with CE marks, strongly hindering the research on the clinical outcomes of rehabilitation treatments based on these devices. A more significant effort is needed to improve the description of the robotic devices used in neurorehabilitation in terms of the technical and functional details, along with high-quality RCT studies.

Introduction Postural instability is a cardinal feature of Parkinson's disease, together with rest tremor, rigidity and bradykinesia. It is a highly disabling symptom that becomes increasingly common with disease progression and represents a major source of reduced quality of life in patients with Parkinson's disease. Rehabilitation aims to enable patients with Parkinson's disease to maintain their maximum level of mobility, activity and independence. To date, a wide range of rehabilitation approaches has been employed to treat postural instability in Parkinson's disease, including robotic training. Our main aim was to conduct a systematic review of current literature about the effects of robot-assisted gait training on postural instability in patients with Parkinson's disease. Evidence acquisition A systematic search using the following MeSH terms "Parkinson disease," "postural balance," "robotics," "rehabilitation" AND string "robotics [mh]" OR "robot-assisted" OR "electromechanical" AND "rehabilitation [mh]" OR "training" AND "postural balance [mh]" was conducted on PubMed, Cochrane Library and Pedro electronic databases. Full text articles in English published up to December 2020 were included. Data about patient characteristics, robotic devices, treatment procedures and outcome measures were considered. Every included article got checked for quality. Level of evidence was defined for all studies. Evidence synthesis Three authors independently extracted and verified data. In total, 18 articles (2 systematic reviews, 9 randomized controlled trials, 4 uncontrolled studies and 3 case series/case reports) were included. Both end-effector and exoskeleton devices were investigated as to robot-assisted gait training modalities. No clear relationship between treatment parameters and clinical conditions was observed. We found a high level of evidence about the effects of robot-assisted gait training on balance and freezing of gait in patients with Parkinson's disease. Conclusions This systematic review provides to the reader a complete overview of current literature and levels of evidence about the effects of robot-assisted gait training on postural instability issues (static and dynamic balance, freezing of gait, falls, confidence in activities of daily living and gait parameters related to balance skills) in patients with Parkinson's disease.

Introduction Stroke is the third leading cause of adult disability world-wide, and lower extremity motor impairment is one of the major determinants of long-term disability. Although robotic therapy is becoming more and more utilized in research protocols for lower limb stroke rehabilitation, the gap between research evidence and its use in clinical practice is still significant. The aim of this study was to determine the scope, quality, and consistency of guidelines for robotic lower limb rehabilitation after stroke, in order to provide clinical recommendations. Evidence acquisition We systematically reviewed stroke rehabilitation guideline recommendations between January 1st, 2010 and October 31th, 2020. We explored electronic databases (n=4), guideline repositories and professional rehabilitation networks (n=12). Two independent reviewers used the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument, and brief syntheses were used to evaluate and compare the different recommendations, considering only the most recent version. Evidence synthesis From the 1219 papers screened, ten eligible guidelines were identified from seven different regions/countries. Four of the included guidelines focused on stroke management, the other six on stroke rehabilitation. Robotic rehabilitation is generally recommended to improve lower limb motor function, including gait and strength. Unfortunately, there is still no consensus about the timing, frequency, training session duration and the exact characteristics of subjects who could benefit from robotics. Conclusions Our systematic review shows that the introduction of robotic rehabilitation in standard treatment protocols seems to be the future of stroke rehabilitation. However, robot assisted gait training (RAGT) for stroke needs to be improved with new solutions and in clinical practice guidelines, especially in terms of applicability.

In this case series study, we aimed to evaluate the feasibility of a subacute rehabilitation program for mechanically ventilated patients with severe consequences of COVID-19 infection. Data were retrospectively collected from seven males (age 37-61 years) who were referred for inpatient rehabilitation following the stay in the ICU (14-22 days). On admission, six patients were still supported by mechanical ventilation. All patients were first placed in isolation in a special COVID unit for 6-22 days. Patients attended 11-24 treatment sessions for the duration of rehabilitation stay (13-27 days), including 6-20 sessions in the COVID unit. The treatment included pulmonary and physical rehabilitation. The initially nonventilated patient was discharged prematurely due to gallbladder problems, whereas all six mechanically ventilated patients were successfully weaned off before transfer to a COVID-free unit where they stayed for 7-19 days. At discharge, all patients increased limb muscle strength and thigh circumference, reduced activity-related dyspnea, regained functional independence and reported better quality of life. Rehabilitation plays a vital role in the recovery of seriously ill post-COVID-19 patients. Facilities should develop and implement plans for providing multidisciplinary rehabilitation treatments in various settings to recover functioning and prevent the development of long-term consequences of the COVID-19 disease.

This paper reports the immediate impact of the epidemic on rehabilitation services in Italy, the first country in Europe hit by COVID-19. In a country with almost 5000 Physical and Rehabilitation Medicine physicians, the webinar had 230 live viewers (4.5%), and more than 8900 individual visualizations of the recorded version. The overall inadequate preparation of the rehabilitation system to face a sudden epidemic was clear, and similar to that of the acute services. The original idea of confining the COVID-19 cases to some areas of rehabilitation wards and/or hospitals, preserving others, proved not to be feasible. Continuous reorganization and adaptation were required due to the rapid changes. Overall, rehabilitation needs had to surrender to the more acute emergency, with total conversion of beds, wards and even hospitals. The quarantine needs heavily involved also outpatient services that were mostly closed. Rehabilitation professionals needed support, but also acted properly, again similarly to what happened in the acute wards. The typical needs of rehabilitation, such as human and physical contacts, but also social interactions including patient, team, family and caregivers, appeared clearly in the current unavoidable need of being suppressed. These notes could serve the preparation of other services worldwide.

[Purpose] The aim of the present study is to detail the protocol for a randomised controlled trial (RCT) of neural manual vs. robotic assisted on pain in sensitivity as well as analyse the quantitative and qualitative movement of hand in subjects with hand osteoarthritis. [Subjects and Methods] Seventy-two patients, aged 50 to 90 years old of both genders, with a diagnosis of hand Osteoarthritis (OA), will be recruited. Two groups of 36 participants will receive an experimental intervention (neurodynamic mobilization intervention plus exercise) or a control intervention (robotic assisted passive mobilization plus exercise) for 12 sessions over 4 weeks. Assessment points will be at baseline, end of therapy, and 1 and 3 months after end of therapy. The outcomes of this intervention will be pain and determine the central pain processing mechanisms. [Result] Not applicable. [Conclusion] If there is a reduction in pain hypersensitivity in hand OA patients it can suggest that supraspinal pain-inhibitory areas, including the periaqueductal gray matter, can be stimulated by joint mobilization.

There is consistent evidence that robotic rehabilitation is at least as effective as conventional physiotherapy for upper extremity (UE) recovery after stroke, suggesting to focus research on which subgroups of patients may better respond to either intervention. In this study, we evaluated which baseline variables are associated with the response after the two approaches. This is a secondary analysis of a randomized-controlled trial comparing robotic and conventional treatment for the UE. After the assigned intervention, changes of the Fugl-Meyer Assessment UE score by ≥ 5 points classified patients as responders to treatment. Variables associated with the response were identified in a univariate analysis. Then, variables independently associated with recovery were investigated, in the whole group, and the two groups separately. A sample of 190 patients was evaluated after the treatment; 121 were responders. Age, baseline impairment, and neglect were significantly associated with worse response to the treatment. Age was the only independently associated variable (OR 0.967, p = 0.023). Considering separately the two interventions, age remained negatively associated with recovery (OR 0.948, p = 0.013) in the conventional group, while none of the variables previously identified were significantly associated with the response to treatment in the robotic group. We found that, in our sample, age is significantly associated with the outcome after conventional but not robotic UE rehabilitation. Possible explanations may include an enhanced positive attitude of the older patients towards technological training and reduced age-associated fatigue provided by robotic-assisted exercise. The possibly higher challenge proposed by robotic training, unbiased by the negative stereotypes concerning very old patients’ expectations and chances to recover, may also explain our findings. NCT02879279.

BACKGROUND To standardize assessment and coordinate processes in stroke rehabilitation, an integrated care pathway (ICP) was developed in an Italian Rehabilitation and Research Institution by a knowledge-translation interdisciplinary process, from evidence-based guidelines to rehabilitation practice. The ICP was implemented in two pilot Tuscan rehabilitation Centers. AIM The purpose of this study was to describe ICP development and assess the ICP effects on postacute stroke inpatient rehabilitation outcomes. DESIGN Prospective observational study, before and after comparison. SETTING Two Tuscan inpatient rehabilitation centers. POPULATION Patients accessing either centers for intensive rehabilitation after acute stroke. METHODS Two cohorts were prospectively recruited before (2015-2017) and after (2018) implementation of the pathway. The primary outcome was change in activities of daily living disability, assessed by the modified Barthel Index (mBI) from admission to discharge. Secondary outcomes included length of stay (LOS), adverse outcomes, and changes in communication ability, trunk control, pain, ambulation, bladder catheter (Y/N), bedsores (Y/N). RESULTS In 2015-2017, 443 postacute stroke patients (mean age 77±11 years, 47% women), while in 2018, 84 patients (mean age 76±13 years, 61% women) were admitted to the two facilities. Comparing the 2018 vs. the 2015-17 cohort, the mean mBI increase was not substantially different (26 vs. 24 points), nor were LOS (37±18 vs. 36±16 days), adverse outcomes, discharge destination, and improvement of ambulation, pain, and communication (P>0.05). Instead, a significantly higher improvement of trunk control (trunk control test: 69.6±33.2 vs. 79.0±31.3, P=0.019), and a higher percentage of bedsore resolution (13% vs. 5%, P=0.033), and bladder catheter removal (37% vs. 17% P

Background and aims Poststroke shoulder pain is a common complication. We aimed to investigate the prevalence of poststroke shoulder pain, with attention to the neuropathic component, and the relationship between poststroke shoulder pain and upper limb improvement in motor function, strength, disability, and quality of life after upper limb rehabilitation. Methods This is a secondary analysis of a multicenter randomized controlled trial to compare upper limb conventional or robotic rehabilitation on 224 patients enrolled in eight rehabilitation centers. We assessed poststroke shoulder pain (using the Numerical Rating Scale and the Douleur Neuropathique 4), and upper limb motor function, strength, disability, and quality of life at baseline (T0), after 30 rehabilitation sessions (T1), and three months after the end of rehabilitation (T2). Results A moderate/severe poststroke shoulder pain was reported by 28.9% of patients, while 19.6% of them showed a neuropathic component. At T0, the intensity of pain was higher in women and in patients with neglect syndrome, positively correlated with the time since stroke and disability and negatively correlated with motor function, strength, and the physical aspects of the quality of life. Moderate/severe pain and neuropathic component significantly reduced after both treatments and this reduction was maintained at T2. Finally, the intensity of pain at baseline was negatively correlated with the improvement of upper limb motor function. Conclusions Poststroke shoulder pain negatively impact on motor performance, strength, disability, and physical aspects of the quality of life as well as on upper limb motor recovery; however, it can be reduced after a robotic or a conventional rehabilitation. Therefore, we suggest considering poststroke shoulder pain when planning the rehabilitation intervention.

Background and purpose After stroke, only 12% of survivors obtain complete upper limb (UL) functional recovery, while in 30% to 60% UL deficits persist. Despite the complexity of the UL, prior robot-mediated therapy research has used only one robot in comparisons to conventional therapy. We evaluated the efficacy of robotic UL treatment using a set of 4 devices, compared with conventional therapy. Methods In a multicenter, randomized controlled trial, 247 subjects with subacute stroke were assigned either to robotic (using a set of 4 devices) or to conventional treatment, each consisting of 30 sessions. Subjects were evaluated before and after treatment, with follow-up assessment after 3 months. The primary outcome measure was change from baseline in the Fugl-Meyer Assessment (FMA) score. Secondary outcome measures were selected to assess motor function, activities, and participation. Results One hundred ninety subjects completed the posttreatment assessment, with a subset (n = 122) returning for follow-up evaluation. Mean FMA score improvement in the robotic group was 8.50 (confidence interval: 6.82 to 10.17), versus 8.57 (confidence interval: 6.97 to 10.18) in the conventional group, with no significant between-groups difference (adjusted mean difference -0.08, P = 0.948). Both groups also had similar change in secondary measures, except for the Motricity Index, with better results for the robotic group (adjusted mean difference 4.42, P = 0.037). At follow-up, subjects continued to improve with no between-groups differences. Discussion and conclusions Robotic treatment using a set of 4 devices significantly improved UL motor function, activities, and participation in subjects with subacute stroke to the same extent as a similar amount of conventional therapy. Video Abstract is available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A291).

Objectives To study if Randomized Controlled Trials (RCTs) on complex interventions published in top journals include all the practical details needed to replicate the intervention in everyday clinical practice (clinical replicability). We chose rehabilitation as a case-study because the World Health Organization calls for its development within health services, and due to its intrinsic complexities. Method Online survey of a pre-defined sample of clinical expert teams from different world regions with diverse rehabilitation competences. Forty-seven clinicians from 7 Physical and Rehabilitation Medicine (PRM) teams (Belgium, Italy, Malaysia, Pakistan, Poland, Puerto Rico, USA), including 20 physicians, 12 physiotherapists, 6 occupational therapists, 6 psychologists and 3 others. The team leaders were active researchers. All RCTs published between January and July 2017 in the top PRM journals (76 RCTs) were reviewed by each team leader. 14 questions developed using CONSORT and TIDIeR checklists through consensus and piloting. Results The response rate was 99%. Inter-rater agreement was moderate/good. All participants considered unanimously 12 (16%) RCTs clinically replicable and none not replicable. Of the other, 56 (74%) RCTs have been considered replicable and 45 (59%) not replicable by at least one complete team. At least one ‘absent’ information was found by all participants in 60 RCTs (79%), and by a minimum of 85% in the remaining 16 (21%). Information considered to be less well described (8-19% ‘perfect’ information) included two providers (skills, experience) and two delivery (cautions, relationships) items. The best described (50-79% ‘perfect’) were the classic methodological items included in CONSORT (descending order: participants, materials, procedures, setting and intervention). Conclusions This rehabilitation case-study shows problems of clinical replicability of RCTs on complex interventions and suggests the need to better define some clinical items not described by classical methodological checklists like CONSORT.

Background: We evaluated the effectiveness of robot-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT) on stroke patients with hand paralysis. Methods: A randomized controlled trial was conducted. Thirty-two patients, 34.4% female (mean ± SD age: 68.9 ± 11.6 years), with hand paralysis after stroke participated. The experimental group received 30 minutes of passive mobilization of the hand through the robotic device Gloreha (Brescia, Italy) , and the control group received an additional 30 minutes of PT and OT for 3 consecutive weeks (3 d/wk) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale, Barthel Index (BI), Motricity Index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH), and the visual analog scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks). Results: A significant effect of time interaction existed for NIHSS, BI, MI, and QuickDASH, after stroke immediately after the interventions (all, P < .001). The experimental group had a greater reduction in pain compared with the control group at the end of the intervention, a reduction of 11.3 mm compared with 3.7 mm, using the 100-mm VAS scale. Conclusions: In the treatment of pain and spasticity in hand paralysis after stroke, robot-assisted mobilization performed in conjunction with traditional PT and OT is as effective as traditional rehabilitation.

The aim of this study is to test the feasibility of a new protocol of upper limb treatment, using a set of four robotic and sensor-based devices in sub-acute stroke patients in a multicenter study aimed to evaluate the efficacy of robotic therapy compared with conventional therapy. Participants are recruited in 8 centers and randomized to either the robotic group or the conventional group. The outcomes were selected according to the International Classification of Functioning, Disability and Health domains, to evaluate body function, activities and participation. A total of 247 participants were randomized, 224 of whom received the allocated intervention. Our results demonstrate the feasibility of our rehabilitation protocol in a multicenter clinical trial and in clinical practice.

Purpose Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. Study design Multicenter randomized controlled trial. Methods Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. Results Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5–88.7, onset months 12.7, range 0.8–19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. Conclusion This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

We evaluated the effectiveness of intrapulmonary percussive ventilation (IPV) compared to traditional standard chest physical therapy (CPT) in patients with chronic obstructive pulmonary disease (COPD) and productive cough.We conducted a quasi-experimental clinical trial. Twenty patients, 40% female (mean ± SD age: 70 ± 8 years), with COPD and productive cough received a multimodal respiratory treatment including IPV and CPT or a control intervention CPT for 10 days.PImax, PEmax, heart rate, respiratory rate, SBP, DBP, Likert scale, Borg dyspnea scale and arterial blood gas analysis: PO2, PCO2, pH, HCO3 and SpO2 measurements. All measures were collected at baseline and at the end of the intervention. We used repeated ANOVA to examine the effects of interventions within groups, between-subjects and the within-subjects.A significant effect of time interaction (F = 7.27; p = 0.015, F = 6.16; p = 0.02 and F = 7.41; p = 0.014) existed for PO2, SpO2 and dyspnea over the moderate COPD and productive cough immediately after the intervention (all, p0.02). Both treatments are similarly effective in PImax and PEmax. No significant group effect or group-by-time interaction was detected for any of them, which suggests that both groups improved in the same way.This study provides evidence that a short-term combination of IPV and CPT improves PO2, SpO2 and perceived dyspnea than a traditional standard CPT in patients with COPD and productive cough.