Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation
NCT ID: NCT06231511
Last Updated: 2025-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
26 participants
INTERVENTIONAL
2021-07-30
2024-04-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Interventions
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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.
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.
Conventional physical therapy
Participants will complete conventional physical therapy without use of exosuits during the course of their inpatient rehabilitation stay.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Harvard University
OTHER
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Director, Max Nader Center for Rehabilitation Technologies & Outcomes Research
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STU00210500
Identifier Type: -
Identifier Source: org_study_id
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