Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

NCT06231511 | Completed Results

• 1 other identifier: STU00210500
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop and evaluate the use of soft exosuits in patients post stroke.

Conditions

Stroke; Acute Stroke

Outcome Measures

Primary Outcomes (1)

• Change in 10 Meter Walk Test

  This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The data table shows the change in gait speed (meters per second) from admission to discharge, time frame varies based on length of stay (estimated 2-4 weeks).

  Admission time-point to discharge time-point (estimated 2-4 weeks). Pre-assessment completed after admission to inpatient rehabilitation, prior to first intervention session. Post-assessment completed following last treatment session, prior to discharge.

Study Arms (3)

AIM 1: Single Group (Hip Flexion Soft Exosuit)

EXPERIMENTAL

For AIM 1, all participants are assigned to the training group using a hip flexion soft exosuit. During the training/tuning sessions, individuals will perform up to 60 minutes of walking with the exosuit on the treadmill, overground or completing stairs, with rest breaks as needed. Goals during these sessions are to modify and update the controllers for the exosuit to appropriately provide assistance to the patient while ambulating in collaboration with Harvard University. We may also test clinical training progressions with the exosuit during walking training. Some part of the session may include walking with the exosuit assisting and other part of the session may include without the device assisting for comparison. Total session time for each session may be up to 2 hours, and up to 8 training/tuning visits will be performed.

Device: Hip flexion soft exosuit

AIM 2: Device Group (ReWalk ReStore Soft Exosuit)

EXPERIMENTAL

For participants in the experimental group, these exosuits will be utilized in up to all physical therapy sessions during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling.

Device: ReWalk ReStore soft exosuit

AIM 2: Control Group

ACTIVE COMPARATOR

Participants in the control group will participate in conventional physical therapy without use of exosuits during the course of the patient's inpatient stay. With the consideration that an inpatient stay may be up to 10 weeks, total number of sessions may be up to 75 visits. Sessions will vary from 30-90 minutes depending on inpatient therapy scheduling.

Other: Conventional physical therapy

Interventions

Hip flexion soft exosuit DEVICE

Participants will utilize a Wyss designed hip flexion soft exosuit. This device has a small rope winch at the front of the hip connected to a functional textile waistband and thigh band. It applies an assistive torque in response to wearable sensor measurements.

AIM 1: Single Group (Hip Flexion Soft Exosuit)

ReWalk ReStore soft exosuit DEVICE

Participants will utilize the ReWalk ReStore ankle soft exosuit. This device provides dynamic plantarflexion and dorsiflexion during walking intended to restore paretic limb function resulting in improved gait symmetry, reduced energy cost of walking and improved stability. The exosuits consists of a body-worn actuation unit containing motors, gears, and pulleys that when powered generate forces that are transmitted via Bowden cables to functional textiles anchored proximal and distal to a joint. This actuation occurs in response to signals from embedded wearable sensors.

AIM 2: Device Group (ReWalk ReStore Soft Exosuit)

Conventional physical therapy OTHER

Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay.

AIM 2: Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years
• History of single stroke event with deficits predominately affecting one side of the body
• Stroke less than 4 years ago (AIM 1)
• Stroke within the past 6 months (AIM 2)
• Capable of standing with assistance
• Medical clearance by a physician

You may not qualify if:

• Inability to communicate with investigators
• Pressure ulcers or skin wounds located where the exosuit interfaces (calf, thigh, waist)
• History of significant peripheral artery disease (PAD)
• Unresolved deep vein thrombosis (DVT)
• Psychiatric or cognitive impairments that may interfere with proper operation of the device
• Known urethane allergies
• Pregnancy
• Other comorbidities that prevent full participation in research

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Harvard University: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sara Prokup PT, DPT
• Organization: Shirley Ryan Abilitylab

sprokup@sralab.org

312-238-1355

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: July 30, 2021
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Locations

US (1)