Self-balancing Personal Exoskeleton for SCI (WINY)
Part of paid clinical trials in New York, New York.
- Sponsor
- Wandercraft
- Study ID
- NCT07222033
- Status
- Recruiting
Conditions
- Paraplegia and Tetraplegia
- Spinal Cord Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Hands-free exoskeleton — DEVICEA "device trainer specialist" from the investigation site will deliver training sessions with the exoskeleton to pair of participants (a pair corresponds to an individual with SCI and his/her companion). The device trainer will follow the progression of the pair through the training program and ensure they learn all the device "basic skills". Each training session lasts an average of 1.5 hours, variations according to the user's learning pace and tolerance. During the sessions with the exoskeleton, the participants will engage in mobility activities on different surfaces and perform Activities of Daily Living in simulated environments such as kitchen, bathroom, elevators and outdoor spaces.
Study Details
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
Key Dates
- Start date
- Aug 11, 2025
- Status verified
- Jan 2026
- Primary completion
- May 31, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Hands-free exoskeleton
Primary Outcome Measure
Safety of the device for its intended use and user population. [ Time Frame: Throughout the study and up until the end of Visit 9, after an average of 9 hours of training and 3 hours of assessment. ]
Central Contacts
- Joshua Breighner, PT DPT646-448-4787
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Walk in New York (WINY) Physical Therapy, P.C. | New York | New York | 10010 | Joshua Breighner, PT DPT (PRINCIPAL_INVESTIGATOR) |
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