NCT06715631

Human Factors Validation Testing of the Wandercraft Personal Exoskeleton

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Wandercraft · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional, national, prospective, open and monocentric study is to demonstrate that a personal exoskeleton can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions.

Detailed description

The Atalante X exoskeleton, Wandercraft's first-generation hands-free, self-balancing device covered by an EC certificate and cleared by the FDA, was primarily utilized in rehabilitation institutions. However, recognizing the potential benefits of self-balancing exoskeleton technology in home settings for individuals with paraplegia and tetraplegia, Wandercraft developed a personal exoskeleton designed for home and community use. The scope of this protocol is to validate all the critical tasks performed by the intended SCI users and companions of the device, according to IEC 62366-1(2020) and the FDA Guidance "Applying human Factors and Usability Engineering to Medical Devices. Up to 14 participants will be recruited and will include: * SCI users: adult patients with motor complete or incomplete SCI with a clinical presentation of a neurological level at or above T6, * Companions: adult individuals in charge of assisting the patient during the use of the device. Both the SCI user and their companion must complete a joint certification program to ensure safe and effective use of the device. The program is provided by a Wandercraft certified trainer and consists of five sessions spread over a maximum period of two months. These sessions include both theoretical presentations on the exoskeleton and practical hands-on training. As a precautionary measure in this usability study, a safety rail will be used to secure the user but it will not be part of the final product. Usability will be assessed by: 1. IFU questionnaire, 2. Simulated tasks test, 3. Final debriefing.

Conditions

• Spinal Cord Injuries
• Tetraplegia
• Paraplegia

Interventions

Type	Name	Description
DEVICE	Hands-free exoskeleton	Before the simulated-use test, the SCI user and his/her companion must attend five training sessions provided by a Wandercraft certified trainer. Training will be composed by a theoretical part including presentation and description of the personal exoskeleton and its use modes and a hands-on practice. Each session lasts between 1 to 2 hours, varying according to the user's learning pace and tolerance. The training program is representative of the intended training for the end product.

Timeline

• Start date: 2024-08-20
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: France