This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
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 in a US investigation site. It aims to enroll up to 12 SCI users and their 12 companions, resulting in 12 SCI user-companion pairs. 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
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.
Walk in New York (WINY) Physical Therapy, P.C.
New York, New York, United States
RECRUITINGSafety of the device for its intended use and user population.
Collection and analysis of adverse events to evaluate the safety of the device for its intended use and user population, specifically for individuals with spinal cord injury (SCI) performing ambulatory activities hands-free, accompanied by a companion.
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.
Proportion of subjects who complete the Timed Up and Go (TUG) in 3min or less.
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.
Time frame: After a mean of 7.5 hours of training and a mean of 9 hours of training.
Proportion of subjects who complete a distance of at least 40m on the Six-Minute Walk Test (6MWT).
The 6MWT measures the distance in meters traversed over 6 min, on indoor surface.
Time frame: After a mean of 7.5 hours of training and a mean of 9 hours of training.
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.
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.
Time frame: After a mean of 7.5 hours of training and a mean of 9 hours of training.
Proportion of subjects who complete the 10-Meter Walk Test (10MWT) on indoor surfaces in 1 minute or less.
The 10MWT measures the time in seconds taken to walk 10 meters.
Time frame: After a mean of 7.5 hours of training and a mean of 9 hours of training.
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Proportion of subjects who can don or doff the device within 10 minutes each, separately.
Time frame: After a mean of 7.5 hours of training and a mean of 9 hours of training.