Self-balancing Personal Exoskeleton for SCI

Part of paid clinical trials in The Bronx, New York.

Sponsor
Wandercraft
Study ID
NCT06777576
Status
Recruiting
Apply to this trial

Conditions

  • Paraplegia and Tetraplegia
  • Spinal Cord Injuries (SCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Hands-free exoskeleton — DEVICE
    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.

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
Feb 12, 2025
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Hands-free exoskeleton

Primary Outcome Measure

Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less. [ Time Frame: At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
James J. Peters, VA Medical Center, Bronx, NYThe BronxNew York10468-3904
Ann M Spungen, EdD
[email protected]
718-584-9000
David Kim
[email protected]
718-584-9000
Ann M Spungen, EdD (PRINCIPAL_INVESTIGATOR)
Stephen Kornfeld, DO (SUB_INVESTIGATOR)
Christopher Cardozo, MD (SUB_INVESTIGATOR)

Find similar trials in The Bronx, NY

By research site
James J. Peters, VA Medical Center, Bronx, NY· The Bronx, NY

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