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

NCT05138016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Soft exosuit

Progressive cardiovascular exercise testing with soft exosuit assistance.

BEHAVIORAL

No Soft exosuit

Progressive cardiovascular exercise testing.

Sponsors & Collaborators

Principal Investigators

  • Anna Roto, MS, MPH · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2022-08-28
Completion
2023-01-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05138016 on ClinicalTrials.gov