Self-balancing Personal Exoskeleton for SCI

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries (SCI); Paraplegia and Tetraplegia

• Registration Number: NCT06777576
• Lead Sponsor: Wandercraft

Brief Summary

This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).

Detailed Description

This personal exoskeleton, developed by Wandercraft as a new version of the Atalante X, offers a novel hands-free and self-balancing design, aiming at enhancing stability and mobility for users in daily activities.

The study features an interventional, prospective, single-group, and open-label design, conducted over 3 to 4 weeks at two US research facilities. 24 subjects are required to complete the study. Anticipating a 15% dropout rate, the study will enroll 29 participants.

Over the course of nine to ten scheduled visits, participants undergo a sequence of procedures, beginning with screening and device fitting. This is followed by five training sessions which conclude with an evaluation to issue a competency certificate to confirm the ability to use the device across all its "basic skills". Additionally, two sessions are dedicated to evaluating the exoskeleton's effectiveness outcomes, complemented by an extra practice session. Each visit lasts an average of 1.5 hours.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-16
• Study Start: 2025-01-27
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.	At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.	The TUG evaluates the time from starting in a seated position to stand-up, walk 3 meters, turn around, walk back 3 meters and sit down on indoor surface.
Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT).	At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.	The 6MWT measures the distance in meters traversed over 6 min, on indoor surface.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who can complete at least 4 out of the 6 Activities of Daily Living (ADLs), in various simulated environments and with the exoskeleton.	At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.	The ADLs are done standing in front of the countertop in the kitchen, in a simulated living room, taking a 50m walk in the outdoor environment, taking the elevator, in the bathroom and walking in a hallway and through a door to get to the next room.
Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less.	At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.	The 10MWT measures the time in seconds taken to walk 10 meters.
Proportion of subjects who can don or doff the device within 10 minutes each, separately.	At visit 7, after an average of 7.5 hours of training and at visit 9, after an average of 9 hours of training.

Trial Locations

Locations (1)

James J. Peters, VA Medical Center, Bronx, NY; 🇺🇸 Bronx, New York, United States