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Recruiting

NCT Number: NCT07061691

WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity

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

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Katelyn Aragon

CONTACT

[email protected]

312-238-8312

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WIM Robotic Exoskeleton

Device

Wearable hip-powered exoskeleton

Primary outcomes

  1. 6-minute walk test

    Time frame: Baseline (Single-session)

    Primary outcome for Optimization aim of study.

  2. Metabolic Cost

    Time frame: Baseline (single session)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Katelyn Aragon

CONTACT

[email protected]

312-238-8312

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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