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Robot-assisted therapy for long-term upper-limb impairment after stroke.

ABSTRACT: Effective rehabilitative therapies are needed for patients with long-term deficits after stroke.In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)

SUBMITTER: Lo AC

PROVIDER: S-EPMC5592692 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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Robot-assisted therapy for long-term upper-limb impairment after stroke.

Lo Albert C AC Guarino Peter D PD Richards Lorie G LG Haselkorn Jodie K JK Wittenberg George F GF Federman Daniel G DG Ringer Robert J RJ Wagner Todd H TH Krebs Hermano I HI Volpe Bruce T BT Bever Christopher T CT Bravata Dawn M DM Duncan Pamela W PW Corn Barbara H BH Maffucci Alysia D AD Nadeau Stephen E SE Conroy Susan S SS Powell Janet M JM Huang Grant D GD Peduzzi Peter P

The New England journal of medicine 20100416 19

<h4>Background</h4>Effective rehabilitative therapies are needed for patients with long-term deficits after stroke.<h4>Methods</h4>In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks ...[more]

PMID: 20400552

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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:ObjectiveTo investigate the effect of robot-assisted therapy (RAT) on upper limb motor control and activity function in poststroke patients compared with that of non-robotic therapy.MethodsWe searched PubMed, EMBASE, Cochrane Library, Google Scholar and Scopus. Randomized controlled trials published from 2010 to nowadays comparing the effect of RAT and control treatment on upper limb function of poststroke patients aged 18 or older were included. Researchers extracted all relevant data from the included studies, assessed the heterogeneity with inconsistency statistics (I2 statistics), evaluated the risk of bias of individual studies and performed data analysis.ResultForty-six studies were included. Meta-analysis showed that the outcome of the Fugl-Meyer Upper Extremity assessment (FM-UE) (SMD = 0.20, P = 0.001) and activity function post intervention was significantly higher (SMD = 0.32, P < 0.001) in the RAT group than in the control group. Differences in outcomes of the FM-UE and activity function between the RAT group and control group were observed at the end of treatment and were not found at the follow-up. Additionally, the outcomes of the FM-UE (SMD = 0.15, P = 0.005) and activity function (SMD = 0.32, P = 0.002) were significantly different between the RAT and control groups only with a total training time of more than 15 h. Moreover, the differences in outcomes of FM-UE and activity post intervention were not significant when the arm robots were applied to patients with severe impairments (FM-UE: SMD = 0.14, P = 0.08; activity: SMD = 0.21, P = 0.06) or when patients were provided with patient-passive training (FM-UE: SMD = - 0.09, P = 0.85; activity: SMD = 0.70, P = 0.16).ConclusionRAT has the significant immediate benefits for motor control and activity function of hemiparetic upper limb in patients after stroke compared with controls, but there is no evidence to support its long-term additional benefits. The superiority of RAT in improving motor control and activity function is limited by the amount of training time and the patients' active participation.

Project description:BackgroundLoss of arm function is a common problem after stroke. Robot-assisted training might improve arm function and activities of daily living. We compared the clinical effectiveness of robot-assisted training using the MIT-Manus robotic gym with an enhanced upper limb therapy (EULT) programme based on repetitive functional task practice and with usual care.MethodsRATULS was a pragmatic, multicentre, randomised controlled trial done at four UK centres. Stroke patients aged at least 18 years with moderate or severe upper limb functional limitation, between 1 week and 5 years after their first stroke, were randomly assigned (1:1:1) to receive robot-assisted training, EULT, or usual care. Robot-assisted training and EULT were provided for 45 min, three times per week for 12 weeks. Randomisation was internet-based using permuted block sequences. Treatment allocation was masked from outcome assessors but not from participants or therapists. The primary outcome was upper limb function success (defined using the Action Research Arm Test [ARAT]) at 3 months. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN69371850.FindingsBetween April 14, 2014, and April 30, 2018, 770 participants were enrolled and randomly assigned to either robot-assisted training (n=257), EULT (n=259), or usual care (n=254). The primary outcome of ARAT success was achieved by 103 (44%) of 232 patients in the robot-assisted training group, 118 (50%) of 234 in the EULT group, and 85 (42%) of 203 in the usual care group. Compared with usual care, robot-assisted training (adjusted odds ratio [aOR] 1·17 [98·3% CI 0·70-1·96]) and EULT (aOR 1·51 [0·90-2·51]) did not improve upper limb function; the effects of robot-assisted training did not differ from EULT (aOR 0·78 [0·48-1·27]). More participants in the robot-assisted training group (39 [15%] of 257) and EULT group (33 [13%] of 259) had serious adverse events than in the usual care group (20 [8%] of 254), but none were attributable to the intervention.InterpretationRobot-assisted training and EULT did not improve upper limb function after stroke compared with usual care for patients with moderate or severe upper limb functional limitation. These results do not support the use of robot-assisted training as provided in this trial in routine clinical practice.FundingNational Institute for Health Research Health Technology Assessment Programme.

Project description:BackgroundIntensive robot-assisted training of the upper limb after stroke can reduce motor impairment, even at the chronic stage. However, the effectiveness of practice for recovery depends on the selection of the practised movements. We hypothesized that rehabilitation can be optimized by selecting the movements to be practiced based on the trainee's performance profile.MethodsWe present a novel principle ('steepest gradients') for performance-based selection of movements. The principle is based on mapping motor performance across a workspace and then selecting movements located at regions of the steepest transition between better and worse performance. To assess the benefit of this principle we compared the effect of 15 sessions of robot-assisted reaching training on upper-limb motor impairment, between two groups of people who have moderate-to-severe chronic upper-limb hemiparesis due to stroke. The test group (N = 7) received steepest gradients-based training, iteratively selected according to the steepest gradients principle with weekly remapping, whereas the control group (N = 9) received a standard "centre-out" reaching training. Training intensity was identical.ResultsBoth groups showed improvement in Fugl-Meyer upper-extremity scores (the primary outcome measure). Moreover, the test group showed significantly greater improvement (twofold) compared to control. The score remained elevated, on average, for at least 4 weeks although the additional benefit of the steepest-gradients -based training diminished relative to control.ConclusionsThis study provides a proof of concept for the superior benefit of performance-based selection of practiced movements in reducing upper-limb motor impairment due to stroke. This added benefit was most evident in the short term, suggesting that performance-based steepest-gradients training may be effective in increasing the rate of initial phase of practice-based recovery; we discuss how long-term retention may also be improved.Trial registrationISRCTN, ISRCTN65226825 , registered 12 June 2018 - Retrospectively registered.

Project description:BackgroundSince birth, during the exploration of the environment to interact with objects, we exploit both the motor and sensory components of the upper limb (UL). This ability to integrate sensory and motor information is often compromised following a stroke. However, to date, rehabilitation protocols are focused primarily on recovery of motor function through physical therapies. Therefore, we have planned a clinical trial to investigate the effect on functionality of UL after a sensorimotor transcranial stimulation (real vs sham) in add-on to robot-assisted therapy in the stroke population.MethodsA randomised double-blind controlled trial design involving 32 patients with a single chronic stroke (onset > 180 days) was planned. Each patient will undergo 15 consecutive sessions (5 days for 3 weeks) of paired associative stimulation (PAS) coupled with UL robot-assisted therapy. PAS stimulation will be administered using a bifocal transcranial magnetic stimulator (TMS) on the posterior-parietal cortex and the primary motor area (real or sham) of the lesioned hemisphere. Clinical, kinematics and neurophysiological changes will be evaluated at the end of protocol and at 1-month follow-up and compared with baseline. The Fugl-Meyer assessment scale will be the primary outcome. Secondly, kinematic variables will be recorded during the box-and-block test and reaching tasks using video analysis and inertial sensors. Single pulse TMS and electroencephalography will be used to investigate the changes in local cortical reactivity and in the interconnected areas.DiscussionThe presented trial shall evaluate with a multimodal approach the effects of sensorimotor network stimulation applied before a robot-assisted therapy training on functional recovery of the upper extremity after stroke. The combination of neuromodulation and robot-assisted therapy can promote an increase of cortical plasticity of sensorimotor areas followed by a clinical benefit in the motor function of the upper limb.Trial registrationClinicalTrials.gov NCT05478434. Registered on 28 Jul 2022.

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Robot-assisted therapy for long-term upper-limb impairment after stroke.

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Robot-assisted therapy for long-term upper-limb impairment after stroke.

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