Self-balancing Personal Exoskeleton for SCI (Site 2)
NCT06814015 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-02-02
Summary
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
Conditions
- Spinal Cord Injuries (SCI)
- Paraplegia and Tetraplegia
Interventions
- DEVICE
-
Hands-free exoskeleton
A "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.
Sponsors & Collaborators
-
Kessler Foundation
collaborator OTHER -
Wandercraft
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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