CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Soft exosuit +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05138016
NCT05138016N/ACompleted

Effects of Soft Robotic Exosuit on Exercise Capacity, Biomakers of Neuroplasticity, and Motor Learning After Stroke

Boston University Charles River Campus·interventional·Posted Nov 30, 2021·Updated Aug 1, 2023

In Brief

A clinical study evaluating Soft exosuit and No Soft exosuit for Stroke. Completed, enrolled 11 participants across 2 sites.

Detailed Summary

High intensity exercise is known to improve a person's ability to learn new motor skills. The goal of this project is to evaluate if a robotic exosuit can help people who have had a stroke perform walking rehabilitation at higher intensities than they are able to without the exosuit. The investigators will measure exercise training intensity, biomarkers of neuroplasticity (e.g., brain-derived neurotrophic factor; BDNF), and motor learning when people poststroke exercise with and without the exosuit. For this protocol, exosuits developed in collaboration with ReWalk™ Robotics will be used. Aim 1: Determine the effects of a soft robotic exosuit on gait training intensity and serum BDNF in persons post-stroke completing a single bout of high intensity walking. Hypothesis 1: Exosuits will allow individuals post-stroke to (i) walk at higher intensities or (ii) walk at a high intensity for longer durations. Hypothesis 2: Training at a higher intensity, or training at high intensity for longer durations, will result in increased serum BDNF. Aim 2: Determine the effects of a soft robotic exosuit on gait biomechanics measured after a single bout of high intensity walking with versus without a soft robotic exosuit. Hypothesis 3: A single bout of high intensity walking with an exosuit will lead to demonstrably better gait biomechanics than a single bout of high intensity exercise without an exosuit.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedNov 30, 2021
Enrollment StartJul 21, 2021
Primary CompletionAug 28, 2022
Study CompletionJan 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.6 years ago

Interventions

Soft exosuitdevice

Progressive cardiovascular exercise testing with soft exosuit assistance.

No Soft exosuitbehavioral

Progressive cardiovascular exercise testing.