Recruiting

Wearable Robot

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT07061691

Conditions

Stroke

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

WIM Robotic Exoskeleton

Study Details

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

Study ID

NCT07061691

Start date

Jul 7, 2025

Status verified date

Aug, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Healthy Population

Interventions

WIM Robotic Exoskeleton

Wearable hip-powered exoskeleton

Primary outcome measure

  • 6-minute walk test [ Time Frame: Baseline (Single-session) ]
  • Metabolic Cost [ Time Frame: Baseline (single session) ]

Central Contacts and Locations

Central contacts

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-08-29.