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

July 28, 2023 updated by: Boston University Charles River Campus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prior studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for impaired paretic limb function during walking. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce post-training improvements in gait quality. Indeed, current rehabilitation efforts are focused on either quality or intensity. They focus on gait quality by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without regard for the quality of their movements. The investigators posit that exosuits can uniquely enable high intensity gait training that promotes quality of movements.

Acute bouts of high intensity exercise prior to skilled task practice have been shown to enhance motor learning in neurologically intact individuals. However, the impact of high intensity exercise on motor learning in clinical populations remains largely unknown. A major limitation to studying this relationship in survivors of stroke are challenges in achieving and maintaining high intensity exercise levels (>75% max HR) during gait training for durations that are comparable to neurologically intact individuals. Exercising at a lower intensity or for a shorter duration may result in insufficient neurological "priming" for motor learning that typically follows high intensity training-which would be evidenced in reduced production of activity-dependent markers of neuroplasticity (e.g., brain-derived neurotrophic factor; BDNF). For this study, the investigators will use standardized, maximal effort tests to evaluate the ability of a soft robotic exosuit to increase a patient's capacity for high intensity gait training. The investigators will also examine the resulting effect on BDNF and the relationship between training intensity, BDNF and motor learning measures.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University
      • Charlestown, Massachusetts, United States, 02129
        • Spaulding Rehabiliation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of stroke
  • Chronic phase of recovery (>6mo post-stroke) (self-report)
  • 18-80 years old (self-report)
  • Independent ambulation (with or without an assistive device) for at least two minutes (confirmed at secondary screening visit)
  • Provide HIPAA Authorization to allow communication with the healthcare provider as needed during the study period
  • Medical clearance by the participant's physician

Exclusion Criteria:

  • Score of > 1 on question 1b and > 0 on question 1c on the NIH Stroke Scale (NIHSS)
  • Inability to communicate
  • Unexplained dizziness in the last 6 months
  • Serious comorbidities that may interfere with the ability to participate in this research (for example: musculoskeletal, cardiovascular, pulmonary, and neurological - other than stroke)
  • Anemia (defined as hemoglobin levels of <13 g/dL for men and <12 g/dL for women)
  • Clotting disorders**
  • Have given blood to any other entity within 60 days prior to blood collection
  • History of significant Peripheral Artery Disease (PAD)
  • Unresolved Deep Vein Thrombosis (DVT)
  • Uncontrolled or untreated hypertension
  • Significant paretic ankle contractures (plantarflexion > 5°)
  • Psychiatric or cognitive impairments that may interfere with the proper operation of the device
  • Presence of open wounds or broken skin at device locations requiring medical management
  • Known urethane allergies

  • Pregnancy

    • Note: If the study team suspects neglect or hemianopia at any time during the course of the research, the physical therapist may administer the Star Cancellation Test (https://www.strokengine.ca/en/assess/sct/) for neglect or a visual field test (e.g., showing visual stimuli on different sides of the body) for hemianopia.

      • Note: We may enroll participants who do not have a clotting disorder, but who are on anti-clotting medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise testing with soft exosuit assistance
Progressive cardiovascular exercise testing on a treadmill with soft exosuit assistance.
Device: Soft exosuit
Progressive cardiovascular exercise testing with soft exosuit assistance.
Active Comparator: Exercise testing without soft exosuit assistance
Progressive cardiovascular exercise testing on a treadmill.
Behavioral: No Soft exosuit
Progressive cardiovascular exercise testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2-Peak
Time Frame: Last 30 seconds of maximal effort exercise test.
Average peak oxygen consumption rate.
Last 30 seconds of maximal effort exercise test.
Duration of high intensity exercise
Time Frame: From the beginning to the end of the test, as determined based on standardized test termination criteria (e.g., volitional fatigue, cardiovascular abnormalities, or physical safety)
Seconds spent exercising at greater than or equal to 76% age-predicted heart rate maximum value.
From the beginning to the end of the test, as determined based on standardized test termination criteria (e.g., volitional fatigue, cardiovascular abnormalities, or physical safety)
Concentration of brain-derived neurotrophic factor (BDNF)
Time Frame: Baseline.
A neurotrophic factor that is essential for learning and memory.
Baseline.
Concentration of brain-derived neurotrophic factor (BDNF)
Time Frame: Immediately after maximal effort exercise test.
A neurotrophic factor that is essential for learning and memory.
Immediately after maximal effort exercise test.
Forward Propulsion
Time Frame: Baseline.
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Baseline.
Forward Propulsion
Time Frame: Immediately after maximal effort exercise test.
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Immediately after maximal effort exercise test.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Physical Activities Questionnaire
Time Frame: Baseline.
A 27-item self-report questionnaire used to collect data on health-related physical activity.
Baseline.
Number of Participants with Rs6265
Time Frame: Baseline.
A single nucleotide polymorphism in the BDNF gene.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Collaborators

American Heart Association
Harvard University
Spaulding Rehabilitation Hospital

Investigators

  • Study Director: Anna Roto, MS, MPH, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Actual)

August 28, 2022

Study Completion (Actual)

January 17, 2023

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

November 28, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4977

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Soft exosuit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe