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Predicting Clinically Significant Improvement After Robot-Assisted Upper Limb Rehabilitation in Subacute and Chronic Stroke.

ABSTRACT: Prior studies examining predictors of favorable clinical outcomes after upper limb robot-assisted therapy (RT) have many shortcomings. Therefore, the aim of this study was to identify meaningful predictors and a prediction model for clinically significant motor improvement in upper limb impairment after RT for each stroke phase. This retrospective, single-center study enrolled patients with stroke who received RT using InMotion2 along with conventional therapy (CT) from January 2015 to September 2019. Demographic characteristics, clinical measures, and robotic kinematic measures were evaluated. The primary outcome measure was the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) and we classified patients with improvement more than the minimal clinically important difference as responders for each stroke phase. Univariable and multivariable logistic regression analyses were performed to assess the relationship between potential predictors and RT responders and determine meaningful predictors. Subsequently, meaningful predictors were included in the final prediction model. One hundred forty-four patients were enrolled. The Hand Movement Scale and time since onset were significant predictors of clinically significant improvement in upper limb impairment (P = 0.045 and 0.043, respectively), as represented by the FMA-UE score after RT along with CT, in patients with subacute stroke. These variables were also meaningful predictors with borderline statistical significance in patients with chronic stroke (P = 0.076 and 0.066, respectively). Better hand movement and a shorter time since onset can be used as realistic predictors of clinically significant motor improvement in upper limb impairment after RT with InMotion2 alongside CT in patients with subacute and chronic stroke. This information may help healthcare professionals discern optimal patients for RT and accurately inform patients and caregivers about outcomes of RT.

SUBMITTER: Lee JJ

PROVIDER: S-EPMC8281036 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundThe efficacy of upper limb (UL) robot-assisted therapy (RAT) on functional improvement after stroke remains unclear. However, recently published randomized controlled trials have supported its potential benefits in enhancing the activities of daily living, arm and hand function, and muscle strength. Task-specific and high-intensity exercises are key points in facilitating motor re-learning in neurorehabilitation since RAT can provide an assisted-as-needed approach. This study aims to investigate the clinical effects of an exoskeleton robotic system for UL rehabilitation compared with conventional therapy (CT) in people with subacute stroke. As a secondary aim, we seek to identify patients' characteristics, which can predict better recovery after UL-RAT and detects whether it could elicit greater brain stimulation.MethodsA total of 84 subacute stroke patients will be recruited from 7 Italian rehabilitation centers over 3 years. The patients will be randomly allocated to either CT (control group, CG) or CT plus UL-RT through an Armeo®Power (Hocoma AG, CH, Volketswil, Switzerland) exoskeleton (experimental group, EG). A sample stratification based on distance since onset, DSO (DSO ≤ 30; DSO > 30), and Fugl-Meyer Assessment (FM)-UL (FM-UL ≤ 22; 22 < FM-UL ≤ 44) will be considered for the randomization. The outcomes will be recorded at baseline (T0), after 25 + 3 sessions of intervention (T1), and at 6 months post-stroke (T2). The motor functioning assessed by the FM-UL (0-66) will be considered the primary outcome. The clinical assessments will be set based on the International Classification of Function, Disability and Health (ICF). A patient satisfaction questionnaire will be evaluated in the EG at T1. A subgroup of patients will be evaluated at T0 and T1 via electroencephalography. Their brain electrical activity will be recorded during rest conditions with their eyes closed and open (5 min each).ConclusionThe results of this trial will provide an in-depth understanding of the efficacy of early UL-RAT through a whole arm exoskeleton and how it may relate to the neural plasticity process. The trial was registered at ClinicalTrial.gov with the registration identifier NCT04697368.

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:BackgroundEffective rehabilitative therapies are needed for patients with long-term deficits after stroke.MethodsIn 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.ResultsAt 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.ConclusionsIn 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.)

Project description:BackgroundRehabilitation robotics is progressing towards developing robots that can be used as advanced tools to augment the role of a therapist. These robots are capable of not only offering more frequent and more accessible therapies but also providing new insights into treatment effectiveness based on their ability to measure interaction parameters. A requirement for having more advanced therapies is to identify how robots can 'adapt' to each individual's needs at different stages of recovery. Hence, our research focused on developing an adaptive interface for the GENTLE/A rehabilitation system. The interface was based on a lead-lag performance model utilising the interaction between the human and the robot. The goal of the present study was to test the adaptability of the GENTLE/A system to the performance of the user.MethodsPoint-to-point movements were executed using the HapticMaster (HM) robotic arm, the main component of the GENTLE/A rehabilitation system. The points were displayed as balls on the screen and some of the points also had a real object, providing a test-bed for the human-robot interaction (HRI) experiment. The HM was operated in various modes to test the adaptability of the GENTLE/A system based on the leading/lagging performance of the user. Thirty-two healthy participants took part in the experiment comprising of a training phase followed by the actual-performance phase.ResultsThe leading or lagging role of the participant could be used successfully to adjust the duration required by that participant to execute point-to-point movements, in various modes of robot operation and under various conditions. The adaptability of the GENTLE/A system was clearly evident from the durations recorded. The regression results showed that the participants required lower execution times with the help from a real object when compared to just a virtual object. The 'reaching away' movements were longer to execute when compared to the 'returning towards' movements irrespective of the influence of the gravity on the direction of the movement.ConclusionsThe GENTLE/A system was able to adapt so that the duration required to execute point-to-point movement was according to the leading or lagging performance of the user with respect to the robot. This adaptability could be useful in the clinical settings when stroke subjects interact with the system and could also serve as an assessment parameter across various interaction sessions. As the system adapts to user input, and as the task becomes easier through practice, the robot would auto-tune for more demanding and challenging interactions. The improvement in performance of the participants in an embedded environment when compared to a virtual environment also shows promise for clinical applicability, to be tested in due time. Studying the physiology of upper arm to understand the muscle groups involved, and their influence on various movements executed during this study forms a key part of our future work.

Project description:BackgroundHand function is often impaired after stroke, strongly affecting the ability to perform daily activities. Upper limb robotic devices have been developed to complement rehabilitation therapy offered to persons who suffered a stroke, but they rarely focus on the training of hand sensorimotor function. The primary goal of this study was to evaluate whether robot-assisted therapy of hand function following a neurocognitive approach (i.e., combining motor training with somatosensory and cognitive tasks) produces an equivalent decrease in upper limb motor impairment compared to dose-matched conventional neurocognitive therapy, when embedded in the rehabilitation program of inpatients in the subacute stage after stroke.MethodsA parallel-group, randomized controlled trial was conducted on subjects with subacute stroke receiving either conventional or robot-assisted neurocognitive hand therapy using a haptic device. Therapy was provided for 15, 45-min sessions over four weeks, nested within the standard therapy program. Primary outcome was the change from baseline in the upper extremity part of the Fugl-Meyer Assessment (FMA-UE) after the intervention, which was compared between groups using equivalence testing. Secondary outcome measures included upper limb motor, sensory and cognitive assessments, delivered therapy dose, as well as questionnaires on user technology acceptance.ResultsThirty-three participants with stroke were enrolled. 14 subjects in the robot-assisted and 13 subjects in the conventional therapy group completed the study. At the end of intervention, week 8 and week 32, the robot-assisted/conventional therapy group improved by 7.14/6.85, 7.79/7.31, and 8.64/8.08 points on the FMA-UE, respectively, establishing that motor recovery in the robot-assisted group is non-inferior to that in the control group.ConclusionsNeurocognitive robot-assisted therapy of hand function allows for a non-inferior motor recovery compared to conventional dose-matched neurocognitive therapy when performed during inpatient rehabilitation in the subacute stage. This allows the early familiarization of subjects with stroke to the use of such technologies, as a first step towards minimal therapist supervision in the clinic, or directly at home after hospital discharge, to help increase the dose of hand therapy for persons with stroke.Trial registrationEUDAMED database (CIV-13-02-009921), clinicaltrials.gov (NCT02096445). Registered 26 March 2014 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02096445.

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Predicting Clinically Significant Improvement After Robot-Assisted Upper Limb Rehabilitation in Subacute and Chronic Stroke.

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