NCT06231511

Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Acute Stroke

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
OTHER	Conventional physical therapy	Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay.

Timeline

• Start date: 2021-07-30
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2024-01-30
• Last updated: 2025-08-14
• Results posted: 2025-08-14

Locations

1 site across 1 country: United States