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Completed

NCT Number: NCT06231511

Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

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

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Key information

Conditions

Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

AIM 1: Develop individualized adaptive controller parameters and a training progression program for these exosuits specific for inpatient stroke rehabilitation.

AIM 2: Evaluate the impact of the soft exosuit + conventional inpatient rehabilitation vs.

conventional inpatient rehabilitation alone on measures of lower-extremity impairments and functional recovery following acute stroke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Conventional physical therapy

Other

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

Primary outcomes

  1. Change in 10 Meter Walk Test

    Time frame: 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.

    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).

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Harvard University

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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