Human Factors Validation Testing of the Wandercraft Personal Exoskeleton (ExoUser)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Tetraplegia; Paraplegia
• Intervention / Treatment: Device: Hands-free exoskeleton

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75004
    • Wandercraft

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

SCI user inclusion criteria:

• Any gender, age 18 years old or older.
• Motor complete or incomplete SCI with a clinical presentation of a neurological level at or above T6.
• Has been released from acute inpatient care following their SCI.
• Able and willing to attend 6 one-to-two-hour sessions of training.
• Able to read, understand, and provide informed consent.
• Patients affiliated to a social security system.

SCI user exclusion criteria:

• Any neurological injury other than spinal cord injury (SCI), except where such injury does not result in physical disability
• Progressive condition that would be expected to result in changing neurological status.
• Severe concurrent medical disease, illness or condition judged to be contraindicated by the site physician.
• Unhealed or unstable traumatic or high impact lower extremity fracture of any duration that is, in the clinical judgement of the study physician, exclusionary for standing and walking.
• Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis.
• Untreatable severe spasticity judged to be contraindicated by the site physician.
• Untreated/uncontrolled hypertension as judged to be contraindicated by the site physician.
• Unresolved orthostatic hypotension as judged to be contraindicated by the site physician.
• History of uncontrolled autonomic dysreflexia.
• Presence of colostomy and/or urostomy.
• Ventilator use at the time of exoskeleton use.
• Presence of life supporting device (e.g., pacemaker).
• Open or unhealed skin pressure sores, abrasions, or bruises at any of the contact points of the exoskeleton.
• Morphological contraindications to the use of the device.
• Uncorrectable leg length discrepancy over 2 cm (about 0.79 in) when using additional correction tools.
• Individuals with functional and/or cognitive impairments that prevent them from effectively operating the device using a hand control interface.
• Improper fitting in the device.
• Psychopathology documentation in the medical record that may conflict with study objectives.
• Pregnancy or women who plan to become pregnant during the study period.
• Concurrent participation in another interventional trial.
• Patient under legal protection.

Companion inclusion criteria:

• Any gender, age 18 years or older.
• Able and willing to attend 6 one-to-two-hour sessions of training.
• Able to read, understand and provide informed consent.

Companion exclusion criteria:

• Inability to communicate with an assistant due to cognitive or language disorders.
• Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol- specified assessments.
• Insufficient strength and performance capability, evidenced by the ability to hold and retain the device in case of unbalance/fall.
• Presence of life supporting device (e.g., pacemaker).
• Concurrent participation in another interventional trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hands-free exoskeleton

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCI user and companion performance when carrying out tasks that are critical tasks	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.	At session 6, after an average of 7.5 hours of training.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use errors, close calls, and use difficulties	Collection of observed use errors, close calls, and use difficulties and identification of critical issues during a simulated-use test - no passing criteria.	At session 6, after an average of 7.5 hours of training.
SCI user and companion general performance when carrying non-critical tasks	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.	At session 6, after an average of 7.5 hours of training.
Readability and clarity of Instructions for Use (IFU)	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.	At session 5, after an average of 6 hours of training.
SCI user and companion opinion on the accompanying documents and 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).	At session 6, after an average of 7.5 hours of training.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCI user and companion satisfaction and comfort	Evaluation of the SCI user and companion satisfaction and comfort on the user interfaces and use modes using 5-level Likert scales. Gather feedback on recommended changes through open-ended questions - no passing criteria.	At session 6, after an average of 7.5 hours of training.
Usability of donning and doffing	Measurement of the time required for donning and doffing during a simulated-use test - no passing criteria.	At session 6, after an average of 7.5 hours of training.
Functional test with the exoskeleton	Evaluation of the SCI user performance (i.e., success and timing) during a Timed Up andGo (TUG) test with the exoskeleton - no passing criteria.	At session 6, after an average of 7.5 hours of training.
SCI user fitting within the device	Assessment of the SCI user skin in the areas of contact with the exoskeleton - no passing criterion.	Through study completion, an average of 9 hours of training and assessment.
Frequency and type of exoskeleton imbalances corrected by the safety rail and by the companion	Collection of data regarding the frequency and type of exoskeleton imbalances corrected by the safety rail and by the companion - no passing criteria.	Through study completion, an average of 9 hours of training and assessment.
Assistance provided by the companion during device use	Evaluation of the level of assistance provided by the companion during the execution of the functional test and donning and doffing - no passing criteria.	At session 6, after an average of 7.5 hours of training.

Collaborators and Investigators

• Sponsor: Wandercraft
• Investigators: Principal Investigator: Rebecca Sauvagnac, MD, Wandercraft

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Robotics; Walking; Spinal Cord Injuries; Community use; Hands-free exoskeleton; Overground exoskeleton; Self-balancing
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: CIP010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No