Trial Outcomes & Findings for Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation (NCT NCT06231511)
NCT ID: NCT06231511
Last Updated: 2025-08-14
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
26 participants
Primary outcome timeframe
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.
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
6
|
5
|
|
Overall Study
COMPLETED
|
14
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
AIM 1: Single Group (Hip Flexion Soft Exosuit)
n=14 Participants
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.
|
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)
n=5 Participants
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.
|
AIM 2: Control Group
n=5 Participants
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.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.7 Years
n=5 Participants
|
54.0 Years
n=7 Participants
|
54.8 Years
n=5 Participants
|
55.8 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
10 Meter Walk Test
|
0.22 m/sec
n=5 Participants
|
0.30 m/sec
n=7 Participants
|
0.46 m/sec
n=5 Participants
|
0.28 m/sec
n=4 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
AIM 1: Single Group (Hip Flexion Soft Exosuit)
n=14 Participants
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.
|
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)
n=5 Participants
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.
|
AIM 2: Control Group
n=5 Participants
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.
|
|---|---|---|---|
|
Change in 10 Meter Walk Test
|
0.48 m/sec
Interval 0.09 to 1.03
|
0.53 m/sec
Interval 0.14 to 1.11
|
0.78 m/sec
Interval 0.32 to 1.06
|
Adverse Events
AIM 1: Single Group (Hip Flexion Soft Exosuit)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AIM 2: Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AIM 1: Single Group (Hip Flexion Soft Exosuit)
n=15 participants at risk
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.
|
AIM 2: Device Group (ReWalk ReStore Soft Exosuit)
n=6 participants at risk
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.
|
AIM 2: Control Group
n=5 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Leave of Absence
|
0.00%
0/15 • Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
|
0.00%
0/5 • Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
|
|
General disorders
Fall Outside Study Procedures
|
0.00%
0/15 • Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
|
16.7%
1/6 • Number of events 1 • Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
|
0.00%
0/5 • Adverse event data was collected at the beginning of each session, up to 7 sessions, until discharge assessment was completed (estimated 2-4 weeks from admission time point, varied based on length of stay in inpatient rehabilitation)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place