Human Factors Validation Testing of the Wandercraft Personal Exoskeleton

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Tetraplegia; Paraplegia

• Registration Number: NCT06715631
• Lead Sponsor: Wandercraft

Brief 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.

Study Timeline

• Study Start: 2024-08-20
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Study First Submitted: 2024-11-18
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
SCI user and companion performance when carrying out tasks that are critical tasks	At session 6, after an average of 7.5 hours of training.	The acceptance criterion for this test is 100% of the trained SCI users and trained companions are able to perform each of the critical task successfully during a simulated-use test.

Secondary Outcome Measures

Name	Time	Method
Use errors, close calls, and use difficulties	At session 6, after an average of 7.5 hours of training.	Collection of observed use errors, close calls, and use difficulties and identification of critical issues during a simulated-use test - no passing criteria.
SCI user and companion general performance when carrying non-critical tasks	At session 6, after an average of 7.5 hours of training.	The acceptance criterion for this test is 90% of the trained SCI users and trained companions are able to perform each of the non-critical task successfully during a simulated-use test.
Readability and clarity of Instructions for Use (IFU)	At session 5, after an average of 6 hours of training.	The acceptance criteria for this test is 100% of the SCI users and companions are able to answer to the critical task questions of the IFU questionnaire correctly and 90% are able to answer to the non-critical task questions correctly.
SCI user and companion opinion on the accompanying documents and training	At session 6, after an average of 7.5 hours of training.	The acceptance criterion for this test is 90% of the trained SCI users and trained companion rate the accompanying documents and training 3 or higher using 5-level Likert scale (1 inadequate, 2 barely adequate, 3 neither adequate nor inadequate, 4 adequate, 5 satisfactory).

Trial Locations

Locations (1)

Wandercraft; 🇫🇷 Paris, France