Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

Shirley Ryan AbilityLab

Status: Completed

Conditions: Stroke; Acute Stroke

Treatments: Other: Conventional physical therapy; Device: Hip flexion soft exosuit; Device: ReWalk ReStore soft exosuit

Study type: Interventional

Funder types: Other

Identifiers

NCT06231511

STU00210500

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

AIM 1: Single Group (Hip Flexion Soft Exosuit)

Experimental group

Description:

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.

Treatment:

Device: Hip flexion soft exosuit

AIM 2: Device Group (ReWalk ReStore Soft Exosuit)

Experimental group

Description:

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.

Treatment:

Device: ReWalk ReStore soft exosuit

AIM 2: Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional physical therapy