StrokeNCT07061691
WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity
A study testing WIM Robotic Exoskeleton in people with Stroke and Healthy, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This study is to develop, test, and optimize a soft hip wearable robot for individuals with stroke, Parkinson's, multiple sclerosis, or older adults with no neurologic deficits. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- What is being tested?
- WIM Robotic Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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..
Who cannot join
- - <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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study is to develop, test, and optimize a soft hip wearable robot for individuals with stroke, Parkinson's, multiple sclerosis, or older adults with no neurologic deficits.
- Being tested
- WIM Robotic Exoskeleton
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIM Robotic ExoskeletonDevice
Wearable hip-powered exoskeleton
| Study group | Role | What they receive |
|---|---|---|
| Healthy Population | Experimental | Not described Receives: Device: WIM Robotic Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Primary outcome for Optimization aim of study.
Measured: Baseline (Single-session)
Metabolic Cost
Primary outcome for Optimization aim of study. Data collected using Cosmed K5 Metabolic Unit
Measured: Baseline (single session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start7 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061691
- Sponsor's protocol ID
- STU00221889
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity
- ClinicalTrials.gov ID
- NCT07061691
- Acronym / sponsor ID
- STU00221889
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to develop, test, and optimize a soft hip wearable robot for individuals with stroke, Parkinson's, multiple sclerosis, or older adults with no neurologic deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Population | Experimental | Device: WIM Robotic Exoskeleton |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (11 listed)
- - <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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WIM Robotic ExoskeletonWearable hip-powered exoskeleton | Device | Healthy Population |
Primary outcome
6-minute walk test
Time frame: Baseline (Single-session)
Primary outcome for Optimization aim of study.
Metabolic Cost
Time frame: Baseline (single session)
Primary outcome for Optimization aim of study. Data collected using Cosmed K5 Metabolic Unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIM Robotic Exoskeleton in people with Stroke and Healthy, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: Baseline (Single-session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.