Dataset Information

Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study.

ABSTRACT:

Background

Stroke is a leading cause of serious gait impairments and restoring walking ability is a major goal of physical therapy interventions. Soft robotic exosuits are portable, lightweight, and unobtrusive assistive devices designed to improve the mobility of post-stroke individuals through facilitation of more natural paretic limb function during walking training. However, it is unknown whether long-term gait training using soft robotic exosuits will clinically impact gait function and quality of movement post-stroke.

Objective

The objective of this pilot study was to examine the therapeutic effects of soft robotic exosuit-augmented gait training on clinical and biomechanical gait outcomes in chronic post-stroke individuals.

Methods

Five post-stroke individuals received high intensity gait training augmented with a soft robotic exosuit, delivered in 18 sessions over 6-8 weeks. Performance based clinical outcomes and biomechanical gait quality parameters were measured at baseline, midpoint, and completion.

Results

Clinically meaningful improvements were observed in walking speed ([Formula: see text] < 0.05) and endurance ([Formula: see text] < 0.01) together with other traditional gait related outcomes. The gait quality measures including hip ([Formula: see text] < 0.01) and knee ([Formula: see text] < 0.05) flexion/extension exhibited an increase in range of motion in a symmetric manner ([Formula: see text] < 0.05). We also observed an increase in bilateral ankle angular velocities ([Formula: see text] < 0.05), suggesting biomechanical improvements in walking function.

Conclusions

The results in this study offer preliminary evidence that a soft robotic exosuit can be a useful tool to augment high intensity gait training in a clinical setting. This study justifies more expanded research on soft exosuit technology with a larger post-stroke population for more reliable generalization. Trial registration This study is registered with ClinicalTrials.gov (ID: NCT04251091).

SUBMITTER: Shin SY

PROVIDER: S-EPMC9164465 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study.

Shin Sung Yul SY Hohl Kristen K Giffhorn Matt M Awad Louis N LN Walsh Conor J CJ Jayaraman Arun A

Journal of neuroengineering and rehabilitation 20220603 1

<h4>Background</h4>Stroke is a leading cause of serious gait impairments and restoring walking ability is a major goal of physical therapy interventions. Soft robotic exosuits are portable, lightweight, and unobtrusive assistive devices designed to improve the mobility of post-stroke individuals through facilitation of more natural paretic limb function during walking training. However, it is unknown whether long-term gait training using soft robotic exosuits will clinically impact gait function ...[more]

PMID: 35655180

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Project description:BackgroundAtypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation.MethodsA multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits.ResultsAll 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05).ConclusionsWhen used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking.Trial registrationNCT03499210. Prospectively registered on March 28, 2018.

Project description:IntroductionHigh-intensity gait training is widely recognized as an effective rehabilitation approach after stroke. Soft robotic exosuits that enhance post-stroke gait mechanics have the potential to improve the rehabilitative outcomes achieved by high-intensity gait training. The objective of this development-of-concept pilot crossover study was to evaluate the outcomes achieved by high-intensity gait training with versus without soft robotic exosuits.MethodsIn this 2-arm pilot crossover study, four individuals post-stroke completed twelve visits of speed-based, high-intensity gait training: six consecutive visits of Robotic Exosuit Augmented Locomotion (REAL) gait training and six consecutive visits without the exosuit (CONTROL). The intervention arms were counterbalanced across study participants and separated by 6 + weeks of washout. Walking function was evaluated before and after each intervention using 6-minute walk test (6MWT) distance and 10-m walk test (10mWT) speed. Moreover, 10mWT speeds were evaluated before each training visit, with the time-course of change in walking speed computed for each intervention arm. For each participant, changes in each outcome were compared to minimal clinically-important difference (MCID) thresholds. Secondary analyses focused on changes in propulsion mechanics and associated biomechanical metrics.ResultsLarge between-group effects were observed for 6MWT distance (d = 1.41) and 10mWT speed (d = 1.14). REAL gait training resulted in an average pre-post change of 68 ± 27 m (p = 0.015) in 6MWT distance, compared to a pre-post change of 30 ± 16 m (p = 0.035) after CONTROL gait training. Similarly, REAL training resulted in a pre-post change of 0.08 ± 0.03 m/s (p = 0.012) in 10mWT speed, compared to a pre-post change of 0.01 ± 06 m/s (p = 0.76) after CONTROL. For both outcomes, 3 of 4 (75%) study participants surpassed MCIDs after REAL training, whereas 1 of 4 (25%) surpassed MCIDs after CONTROL training. Across the training visits, REAL training resulted in a 1.67 faster rate of improvement in walking speed. Similar patterns of improvement were observed for the secondary gait biomechanical outcomes, with REAL training resulting in significantly improved paretic propulsion for 3 of 4 study participants (p < 0.05) compared to 1 of 4 after CONTROL.ConclusionSoft robotic exosuits have the potential to enhance the rehabilitative outcomes produced by high-intensity gait training after stroke. Findings of this development-of-concept pilot crossover trial motivate continued development and study of the REAL gait training program.

Project description:BackgroundMuscle synergies analysis can provide a deep understanding of motor impairment after stroke and of changes after rehabilitation. In this study, the neuro-mechanical analysis of leg cycling was used to longitudinally investigate the motor recovery process coupled with cycling training augmented by Functional Electrical Stimulation (FES) in subacute stroke survivors.MethodsSubjects with ischemic subacute stroke participated in a 3-week training of FES-cycling with visual biofeedback plus usual care. Participants were evaluated before and after the intervention through clinical scales, gait spatio-temporal parameters derived from an instrumented mat, and a voluntary pedaling test. Biomechanical metrics (work produced by the two legs, mechanical effectiveness and symmetry indexes) and bilateral electromyography from 9 leg muscles were acquired during the voluntary pedaling test. To extract muscles synergies, the Weighted Nonnegative Matrix Factorization algorithm was applied to the normalized EMG envelopes. Synergy complexity was measured by the number of synergies required to explain more than 90% of the total variance of the normalized EMG envelopes and variance accounted for by one synergy. Regardless the inter-subject differences in the number of extracted synergies, 4 synergies were extracted from each patient and the cosine-similarity between patients and healthy weight vectors was computed.ResultsNine patients (median age of 75 years and median time post-stroke of 2 weeks) were recruited. Significant improvements in terms of clinical scales, gait parameters and work produced by the affected leg were obtained after training. Synergy complexity well correlated to the level of motor impairment at baseline, but it did not change after training. We found a significant improvement in the similarity of the synergy responsible of the knee flexion during the pulling phase of the pedaling cycle, which was the mostly compromised at baseline. This improvement may indicate the re-learning of a more physiological motor strategy.ConclusionsOur findings support the use of the neuro-mechanical analysis of cycling as a method to assess motor recovery after stroke, mainly in an early phase, when gait evaluation is not yet possible. The improvement in the modular coordination of pedaling correlated with the improvement in motor functions and walking ability achieved at the end of the intervention support the role of FES-cycling in enhancing motor re-learning after stroke but need to be confirmed in a controlled study with a larger sample size.Trial registrationClinicalTrial.gov, NCT02439515. Registered on May 8, 2015, .

Dataset Information

Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study.

Background

Objective

Methods

Results

Conclusions

Publications

Soft robotic exosuit augmented high intensity gait training on stroke survivors: a pilot study.

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