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Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke.

ABSTRACT: BACKGROUND:The aim of the present study was to to assess the relative effectiveness of the various types of electromechanical-assisted arm devices and approaches after stroke. METHOD:This is a systematic review of randomized controlled trials with network meta-analysis. Our primary endpoints were activities of daily living (measured e.g. with Barthel-Index) and hand-arm function (measured e.g. with the Fugl-Meyer Scale for the upper limb), our secondary endpoints were hand-arm strength (measured e.g. with the Motricity Index) and safety. We used conventional arm training as our reference category and compared it with different intervention categories of electromechanical-assisted arm training depending on the therapy approach. We did indirect comparisons between the type of robotic device. We considered the heterogeneity of the studies by means of confidence and prediction intervals. RESULTS:Fifty five randomized controlled trials, including 2654 patients with stroke, met our inclusion criteria. For the primary endpoints activities of daily living and hand-arm function and the secondary endpoint hand-arm strength, none of the interventions achieved statistically significant improvements, taking into account the heterogeneity of the studies. Safety did not differ with regard to the individual interventions of arm rehabilitation after stroke. CONCLUSION:The outcomes of robotic-assisted arm training were comparable with conventional therapy. Indirect comparisons suggest that no one type of robotic device is any better or worse than any other device, providing no clear evidence to support the selection of specific types of robotic device to promote hand-arm recovery. TRIAL REGISTRATION:PROSPERO 2017 CRD42017075411.

SUBMITTER: Mehrholz J

PROVIDER: S-EPMC7325016 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke.

Mehrholz Jan J Pollock Alex A Pohl Marcus M Kugler Joachim J Elsner Bernhard B

Journal of neuroengineering and rehabilitation 20200630 1

<h4>Background</h4>The aim of the present study was to to assess the relative effectiveness of the various types of electromechanical-assisted arm devices and approaches after stroke.<h4>Method</h4>This is a systematic review of randomized controlled trials with network meta-analysis. Our primary endpoints were activities of daily living (measured e.g. with Barthel-Index) and hand-arm function (measured e.g. with the Fugl-Meyer Scale for the upper limb), our secondary endpoints were hand-arm str ...[more]

PMID: 32605587

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Project description:BACKGROUND:Electromechanical and robot-assisted arm training devices are used in rehabilitation, and may help to improve arm function after stroke. OBJECTIVES:To assess the effectiveness of electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength in people after stroke. We also assessed the acceptability and safety of the therapy. SEARCH METHODS:We searched the Cochrane Stroke Group's Trials Register (last searched January 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2018, Issue 1), MEDLINE (1950 to January 2018), Embase (1980 to January 2018), CINAHL (1982 to January 2018), AMED (1985 to January 2018), SPORTDiscus (1949 to January 2018), PEDro (searched February 2018), Compendex (1972 to January 2018), and Inspec (1969 to January 2018). We also handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trialists, experts, and researchers in our field, as well as manufacturers of commercial devices. SELECTION CRITERIA:Randomised controlled trials comparing electromechanical and robot-assisted arm training for recovery of arm function with other rehabilitation or placebo interventions, or no treatment, for people after stroke. DATA COLLECTION AND ANALYSIS:Two review authors independently selected trials for inclusion, assessed trial quality and risk of bias, used the GRADE approach to assess the quality of the body of evidence, and extracted data. We contacted trialists for additional information. We analysed the results as standardised mean differences (SMDs) for continuous variables and risk differences (RDs) for dichotomous variables. MAIN RESULTS:We included 45 trials (involving 1619 participants) in this update of our review. Electromechanical and robot-assisted arm training improved activities of daily living scores (SMD 0.31, 95% confidence interval (CI) 0.09 to 0.52, P = 0.0005; I² = 59%; 24 studies, 957 participants, high-quality evidence), arm function (SMD 0.32, 95% CI 0.18 to 0.46, P < 0.0001, I² = 36%, 41 studies, 1452 participants, high-quality evidence), and arm muscle strength (SMD 0.46, 95% CI 0.16 to 0.77, P = 0.003, I² = 76%, 23 studies, 826 participants, high-quality evidence). Electromechanical and robot-assisted arm training did not increase the risk of participant dropout (RD 0.00, 95% CI -0.02 to 0.02, P = 0.93, I² = 0%, 45 studies, 1619 participants, high-quality evidence), and adverse events were rare. AUTHORS' CONCLUSIONS:People who receive electromechanical and robot-assisted arm training after stroke might improve their activities of daily living, arm function, and arm muscle strength. However, the results must be interpreted with caution although the quality of the evidence was high, because there were variations between the trials in: the intensity, duration, and amount of training; type of treatment; participant characteristics; and measurements used.

Project description:BackgroundUpper limb recovery is one of the main goals of post-stroke rehabilitation due to its importance for autonomy in Activities of Daily Living (ADL). Although the efficacy of upper limb Robot-assisted Therapy (RT) is well established in literature, the impact of the initial status of the patient on the effects of RT is still understudied. This paper aims to identify whether demographic, clinical and motor characteristics of stroke patients may influence the ability to independently perform ADL after RT.MethodsA retrospective study was conducted on sixty stroke patients who conducted planar upper limb goal-directed tasks with the InMotion 2.0 robot. The RT was administered 5 days/week for 4 weeks and each session lasted 45 minutes. The primary outcome measure was the Modified Barthel Index (BI), dichotomized into favourable (BI ≥75) and unfavourable (BI<75) outcomes. The potential predictors were the demographic and clinical records, and the following clinical assessment scores: Modified Ashworth Scale-Shoulder (MAS-S); Modified Ashworth Scale-Elbow (MAS-E); Fugl-Meyer Assessment Upper Extremity (FMA-UE); upper limb section of the Motricity Index (MIul); total passive Range Of Motion (pROM); and Box and Block Test (BBT).ResultsStatistical analysis showed that the BBT, FMA-UE and MIul scores were significant predictors of a favourable outcome in ADL. The cut-off scores of the independent variables were calculated (FMA-UE = 32; MIul = 48; BBT = 3) with respect to the dichotomic BI outcome. Their robustness was assessed with the Fragility Index (FMA-UE = 2; MIul = 3; BBT = 7), showing that BBT is the most robust predictor of favourable BI outcome. Moreover, subjects with all predictors higher than the cut-off scores had higher probability to increase their independence in ADL at the end of the therapy. Demographic records, spasticity and pROM were not identified as predictors.ConclusionStroke patients with greater manual dexterity and less impairment appear to have a higher probability of achieving clinically significant ADL outcomes after upper limb RT. The obtained results can help to optimise the management of RT treatment planning. Further studies on a larger number of patients with a long-term follow up are recommended in order to evaluate other potential predictors and to validate the results.

Project description:BackgroundRobotic training with high repetitions facilitates upper-limb movements but provides fewer benefits for activities of daily living. Integrating activities of daily living training tasks and mirror therapy into a robot may enhance the functional gains of robotic training.AimThe aim of this study was to investigate the feasibility, safety, and efficacy of the task-oriented mirrored upper-limb robotic training on the upper-limb functions and activities of daily living of subacute poststroke patients.DesignThis study is a single-blinded, active-controlled pilot study.SettingThe study was carried out at rehabilitation outpatient clinic and ward.PopulationA total of 32 subacute poststroke patients were enrolled in the study.MethodsThe enrolled patients were allocated into two groups in a ratio of 1:1. The experimental group received 4 weeks of task-oriented mirrored upper-limb robotic training, consisting of five sessions of 30-minute duration, along with 30 minutes of conventional training. The control group only received 60 minutes of conventional training. The outcome measures were the Fugl-Meyer Assessment Scale for Upper Extremity, Modified Barthel Index, Stroke Self-Efficacy Scale, System Usability Scale, and Quebec User Evaluation with Assistive Technology.ResultsAll patients completed the full training sessions without significant adverse events related to robotic training. The task-oriented mirrored upper-limb robotic training led to increased Fugl-Meyer Assessment Scale for Upper Extremity (difference: 10.38 points, P<0.001) and Modified Barthel Index (difference: 18.38 points, P<0.001) scores, both of which exceeded the minimal clinically important difference. Intergroup analysis showed significantly higher improvements in the Fugl-Meyer Assessment Scale for Upper Extremity total scores, shoulder, wrist, and hand scores; and Modified Barthel Index scores in the experimental group than in conventional training (all P<0.05). Both groups showed significant improvements in Stroke Self-Efficacy Scale scores after the intervention (both P<0.001), but without a statistically significant intergroup difference (P>0.05). Participants in the experimental group scored an average usability perception score of 74.74 (good) and an average satisfaction score of four or more out of five.ConclusionsIn general, task-oriented mirrored upper-limb robotic training appears feasible and safe for subacute poststroke rehabilitation, facilitating the recovery of upper-limb functions and activities of daily living.Clinical rehabilitation impactTask-oriented mirrored upper-limb robotic training shows promise for future clinical rehabilitation and clinical trials involving subacute poststroke patients.

Project description:BACKGROUND:Effective poststroke motor rehabilitation depends on repeated limb practice with voluntary efforts. An electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-robot arm was designed for the multi-joint physical training on the elbow, the wrist, and the fingers. OBJECTIVES:To investigate the training effects of the device-assisted approach on subacute stroke patients and to compare the effects with those achieved by the traditional physical treatments. METHOD:This study was a pilot randomized controlled trial with a 3-month follow-up. Subacute stroke participants were randomly assigned into two groups, and then received 20-session upper limb training with the EMG-driven NMES-robotic arm (NMES-robot group, n?=?14) or the time-matched traditional therapy (the control, n?=?10). For the evaluation of the training effects, clinical assessments including Fugl-Meyer Assessment (FMA), Modified Ashworth Score (MAS), Action Research Arm Test (ARAT), and Function Independence Measurement (FIM) were conducted before, after the rehabilitation training, and 3?months later. Session-by-session EMG parameters in the NMES-robot group, including normalized co-contraction Indexes (CI) and EMG activation level of target muscles, were used to monitor the progress in muscular coordination patterns. RESULTS:Significant improvements were obtained in FMA (full score and shoulder/elbow), ARAT, and FIM [P?<?0.001, effect sizes (EFs)?>?0.279] for both groups. Significant improvement in FMA wrist/hand was only observed in the NMES-robot group (P?<?0.001, EFs?=?0.435) after the treatments. Significant reduction in MAS wrist was observed in the NMES-robot group after the training (P?<?0.05, EFs?=?0.145) and the effects were maintained for 3?months. MAS scores in the control group were elevated following training (P?<?0.05, EFs?>?0.24), and remained at an elevated level when assessed 3?months later. The EMG parameters indicated a release of muscle co-contraction in the muscle pairs of biceps brachii and flexor carpi radialis and biceps brachii and triceps brachii, as well as a reduction of muscle activation level in the wrist flexor in the NMES-robot group. CONCLUSION:The NMES-robot-assisted training was effective for early stroke upper limb rehabilitation and promoted independence in the daily living comparable to the traditional physical therapy. It could achieve higher motor outcomes at the distal joints and more effective release in muscle tones than the traditional therapy. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, identifier NCT02117089; date of registration: April 10, 2014.

Project description:ObjectiveTo evaluate if bilateral or unilateral upper limb robot-assisted rehabilitation training using a new three-dimensional end-effector robot that targets shoulder and elbow flexion and abduction is superior to conventional therapy with regard to upper extremity motor function recovery and neuromuscular improvement in stroke patients.DesignRandomized, controlled, parallel, assessor-blinded, three-arm clinical trial.SettingSoutheast University Zhongda Hospital Nanjing, Jiangsu, China.MethodsSeventy patients with hemiplegic stroke were randomly assigned to conventional training (Control, n = 23) or unilateral (URT, n = 23), or bilateral robotic training (BRT, n = 24). The conventional group received routine rehabilitation, 60 min/day, 6 days/week, for 3 weeks. For URT and BRT upper limb robot-assisted rehabilitation training was added. This was 60 min/day, 6 days/week, for 3 weeks. The primary outcome was upper limb motor function assessed with Fugl-Meyer-Upper Extremity Scale (FMA-UE). Secondary outcomes were activities of daily living (ADL) assessed with the Modified Barthel Index (MBI), Motor Evoked Potential (MEP) to assess corticospinal tract connectivity, Root Mean Square (RMS) value, and integrate Electromyography (iEMG) value recorded by surface electromyography to evaluate muscle contraction function.ResultsThe primary outcome indicator FMA-UE (least square mean (LSMEAN): 31.40, 95% confidence interval (95% CI): 27.74-35.07) and the secondary outcome indicator MBI (LSMEAN: 69.95, 95% CI: 66.69-73.21) were significantly improved in BRT as opposed to control (FMA-UE, LSMEAN: 24.79, 95% CI: 22.23-27.35; MBI, LSMEAN: 62.75, 95% CI: 59.42-66.09); and unilateral (FMA-UE, LSMEAN: 25.97, 95% CI: 23.57-28.36; MBI, LSMEAN: 64.34, 95% CI: 61.01-67.68). BRT also showed greater improvement in the anterior deltoid bundle with regard to muscle contraction function indicated by RMS (LSMEAN: 257.79, 95% CI: 211.45-304.12) and iEMG (LSMEAN: 202.01, 95% CI: 167.09-236.94), as compared to the controls (RMS, LSMEAN: 170.77, 95% CI: 148.97-192.58; iEMG, LSMEAN: 132.09, 95% CI: 114.51-149.68), and URT (RMS, LSMEAN: 179.05, 95% CI: 156.03-202.07; iEMG, LSMEAN: 130.38, 95% CI: 107.50-153.26). There was no statistically significant difference between URT and conventional training for any outcome. There was no significant difference in MEP extraction rate after treatment between groups (p = 0.54 for URT, p = 0.08 for BRT).ConclusionsA 60 min daily training for upper extremities using a three-dimensional end-effector targeting elbow and shoulder adding conventional rehabilitation appears to promote upper limb function and ADL in stroke patients only if delivered bilaterally. URT does not seem to result in better outcomes than conventional rehabilitation. Electrophysiological results suggest that training using a bilateral upper limb robot increases the recruitment of motor neurons rather than improving the conduction function of the corticospinal tract.

Project description:Post stroke upper limb rehabilitation is a challenging problem with poor outcomes as 40% of survivors have functionally useless upper limbs. Robot-aided therapy (RAT) is a potential method to alleviate the effort of intensive, task-specific, repetitive upper limb exercises for both patients and therapists. The present study aims to investigate how a time matched combinatory training scheme that incorporates conventional and RAT, using H-Man, compares with conventional training toward reducing workforce demands. In a randomized control trial (NCT02188628, www.clinicaltrials.gov), 44 subacute to chronic stroke survivors with first-ever clinical stroke and predominant arm motor function deficits were recruited and randomized into two groups of 22 subjects: Robotic Therapy (RT) and Conventional Therapy (CT). Both groups received 18 sessions of 90 min; three sessions per week over 6 weeks. In each session, participants of the CT group received 90 min of 1:1 therapist-supervised conventional therapy while participants of the RT group underwent combinatory training which consisted of 60 min of minimally-supervised H-Man therapy followed by 30 min of conventional therapy. The clinical outcomes [Fugl-Meyer (FMA), Action Research Arm Test and, Grip Strength] and the quantitative measures (smoothness, time efficiency, and task error, derived from two robotic assessment tasks) were independently evaluated prior to therapy intervention (week 0), at mid-training (week 3), at the end of training (week 6), and post therapy (week 12 and 24). Significant differences within group were observed at the end of training for all clinical scales compared with baseline [mean and standard deviation of FMA score changes between baseline and week 6; RT: Δ4.41 (3.46) and CT: Δ3.0 (4.0); p < 0.01]. FMA gains were retained 18 weeks post-training [week 24; RT: Δ5.38 (4.67) and week 24 CT: Δ4.50 (5.35); p < 0.01]. The RT group clinical scores improved similarly when compared to CT group with no significant inter-group at all time points although the conventional therapy time was reduced to one third in RT group. There were no training-related adverse side effects. In conclusion, time matched combinatory training incorporating H-Man RAT produced similar outcomes compared to conventional therapy alone. Hence, this study supports a combinatory approach to improve motor function in post-stroke arm paresis. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02188628.

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Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke.

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Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke.

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