WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity

NCT07061691 | Recruiting

• 1 other identifier: STU00221889
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to develop, test, and optimize a soft hip wearable robot for individuals who have experience a stroke.

Conditions

Stroke; Healthy

Outcome Measures

Primary Outcomes (2)

• 6-minute walk test

  Primary outcome for Optimization aim of study.

  Baseline (Single-session)

• Metabolic Cost

  Primary outcome for Optimization aim of study. Data collected using Cosmed K5 Metabolic Unit

  Baseline (single session)

Study Arms (1)

Healthy Population

EXPERIMENTAL

Device: WIM Robotic Exoskeleton

Interventions

WIM Robotic Exoskeleton DEVICE

Wearable hip-powered exoskeleton

Healthy Population

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Be at least 6 months post-stroke, have a diagnosis of Parkinson's, have a diagnosis of multiple sclerosis, or an adult older than 65 with no known neurological diagnoses.
• For the Optimization Aim of the study, Participants may also be healthy individuals with no known impairments.
• Age: 18-89 years of age
• For stroke, Parkinson's, multiple sclerosis, or older adult participants, must have adequate cognitive function (MMSE score \>17)
• Ability to walk at least 10 meters with maximum of 1 person assist
• Able to safely fit into the WIM exosuit, which is confirmed via an in-person fitting..

You may not qualify if:

• \- \<90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement.)
• \< 6 months post CABG or cardiac valve procedure
• Any skin irritations / conditions that may preclude a participant from tolerating the use of the exosuit.
• Severe osteoporosis, defined as osteoporosis that has been diagnosed and a participant's doctor has recommended pharmacologic treatment, or there is both a history of osteoporosis and a history of fractures.
• Serious cardiac conditions, such as hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living.
• Pregnancy
• Uncontrolled hypertension (resting systolic blood pressure greater than or equal to 150, or resting diastolic pressure greater than or equal to 90.) If a participant demonstrates a BP greater than these values, then the participant will sit quietly for 5 mins, and then be re-checked. If the BP values remain over those thresholds, then the participant will be excluded. Individuals in such situations may return to be re-screened for participation after they follow up with their physician and the hypertension is better controlled.
• Lower extremity fracture, either currently or within the past 6 months.
• Modified Ashworth Spasticity (MAS) scores of ≥ 3 in hip flexors or extensors, if the participant is post-stroke or multiple sclerosis.
• Pre-existing neurological disorders such as amyotrophic lateral sclerosis (ALS), dementia
• History of major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, ongoing active infections, legal blindness, or a history of significant psychiatric illness.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Katelyn Aragon

CONTACT

312-238-8312; karagon@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator:Arun Jayaraman, PT, PhD,Shirley Ryan AbilityLab

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 11, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)