N/A N=26 Randomized Treatment

Soft Exosuits for Functional Gait Recovery in Acute Stroke Rehabilitation

Stroke · Acute Stroke

Bottom Line

View on ClinicalTrials.gov: NCT06231511 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Change in 10 Meter Walk Test — 0.48; 0.53; 0.78 m/sec

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hip flexion soft exosuit (Device); ReWalk ReStore soft exosuit (Device); Conventional physical therapy (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shirley Ryan AbilityLab
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in 10 Meter Walk Test	0.48; 0.53; 0.78	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06231511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.