RECRUITING

WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

WIM Exosuit Wearable Soft Robot for Enhancing Walking Activity

Quick Facts

Study Start:2025-07

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07061691

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.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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..	* - \<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.

Inclusion Criteria

Exclusion 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.
* 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..

* - \<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.

Contacts and Locations

Study Contact

Katelyn Aragon

CONTACT

312-238-8312

karagon@sralab.org

Study Locations (Sites)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-07

Study Completion Date2028-07

Study Record Updates

Study Start Date2025-07

Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

Stroke
Healthy