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Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06231511
Enrollment
26
Registered
2024-01-30
Start date
2021-07-30
Completion date
2024-04-15
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Stroke

Brief summary

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

Detailed description

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.

Interventions

DEVICEHip flexion soft exosuit

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.

DEVICEReWalk ReStore soft exosuit

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.

OTHERConventional physical therapy

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

Sponsors

Harvard University
CollaboratorOTHER
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in 10 Meter Walk TestAdmission 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
AIM 1: Single Group (Hip Flexion Soft Exosuit)
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. Hip flexion soft exosuit: 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.
14
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)
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. ReWalk ReStore soft exosuit: 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.
5
AIM 2: Control Group
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. Conventional physical therapy: Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay.
5
Total24

Baseline characteristics

CharacteristicAIM 1: Single Group (Hip Flexion Soft Exosuit)TotalAIM 2: Control GroupAIM 2: Device Group (ReWalk ReStore Soft Exosuit)
10 Meter Walk Test0.22 m/sec0.28 m/sec0.46 m/sec0.30 m/sec
Age, Continuous56.7 Years55.8 Years54.8 Years54.0 Years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants7 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants17 Participants4 Participants3 Participants
Region of Enrollment
United States
14 Participants24 Participants5 Participants5 Participants
Sex: Female, Male
Female
6 Participants13 Participants3 Participants4 Participants
Sex: Female, Male
Male
8 Participants11 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 60 / 5
other
Total, other adverse events
0 / 152 / 60 / 5
serious
Total, serious adverse events
0 / 150 / 60 / 5

Outcome results

Primary

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).

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.

ArmMeasureValue (MEAN)
AIM 1: Single Group (Hip Flexion Soft Exosuit)Change in 10 Meter Walk Test0.48 m/sec
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)Change in 10 Meter Walk Test0.53 m/sec
AIM 2: Control GroupChange in 10 Meter Walk Test0.78 m/sec

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026