Empowering Mobility in People With Spinal Cord Injury With a Hands-free, Self-balancing Personal Exoskeleton
Wandercraft
Summary
This study aims to demonstrate the safety and effectiveness of the personal exoskeleton in individuals with spinal cord injury (SCI).
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 scree…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
SCI user inclusion Criteria: * Any gender, age 18 years or older; * Motor complete or incomplete SCI with lesions at or above T6; * ≥ 6 months post SCI; * Able and willing to attend 9 to 10 visits1 to the center, including sessions of training and assessments of one-to-three hours duration; * Able to read, understand, and provide informed consent; * Living in the US and speaks English. SCI user exclusion Criteria: * Diagnosis of neurological injury other than SCI; * Progressive condition that would be expected to result in changing neurological status; * Severe concurrent medical disease, i…
Interventions
- DeviceHands-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.
Location
- James J. Peters, VA Medical Center, Bronx, NYThe Bronx, New York