WIM exosuit: a soft hip wearable robot to enhance walking
WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity
This study will test a soft hip wearable robot to help adults with stroke, Parkinson's disease, multiple sclerosis, and older adults walk better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07061691 on ClinicalTrials.gov |
What this trial studies
Researchers will develop, optimize, and test the WIM soft hip exosuit by fitting participants in the device and measuring walking activity during supervised sessions. The interventional protocol enrolls people at least six months post-stroke, those with Parkinson's or MS, older adults, and healthy volunteers for optimization, all aged 18–89. Participants must be able to walk at least 10 meters with no more than one-person assistance and pass a cognitive screen, and testing requires an in-person fitting to ensure safe use of the exosuit. Outcomes will focus on walking activity, gait performance, device fit and tolerability, and safety.
Who should consider this trial
Good fit: Adults 18–89 who are at least 6 months post-stroke, have Parkinson's disease or multiple sclerosis, or are older than 65 without neurological diagnoses (and who can walk 10 meters with ≤1-person assist and have adequate cognition), with healthy volunteers eligible for optimization.
Not a fit: People under 6 months post-stroke, those with recent major orthopedic or cardiac surgery, severe osteoporosis, skin conditions preventing device use, or who cannot safely fit into the exosuit are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the exosuit could increase walking activity, reduce effort, and improve mobility and independence for people with gait impairments.
How similar studies have performed: Earlier small trials of soft exosuits and powered hip devices have shown promising improvements in gait and walking efficiency, so this work builds on encouraging preliminary results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Katelyn Aragon
- Email: karagon@sralab.org
- Phone: 312-238-8312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.