WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity

August 22, 2025 updated by: Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
This study is to develop, test, and optimize a soft hip wearable robot for individuals who have experience a stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Shirley Ryan Abilitylab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - 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..

Exclusion Criteria:

  • - <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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Population
Device: WIM Robotic Exoskeleton
Wearable hip-powered exoskeleton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk test
Time Frame: Baseline (Single-session)
Primary outcome for Optimization aim of study.
Baseline (Single-session)
Metabolic Cost
Time Frame: Baseline (single session)
Primary outcome for Optimization aim of study. Data collected using Cosmed K5 Metabolic Unit
Baseline (single session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

June 27, 2025

First Submitted That Met QC Criteria

July 8, 2025

First Posted (Actual)

July 11, 2025

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00221889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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