Clinical trial NCT06715631: Human Factors Validation Testing of the Wandercraft Personal Exoskeleton
Official title: Human Factors Validation Testing of the Wandercraft Personal Exoskeleton
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Tetraplegia
Paraplegia
Keywords: Spinal Cord Injuries
Robotics
Community use
Hands-free exoskeleton
Overground exoskeleton
Walking
Self-balancing
Lead sponsor: Wandercraft
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SCI user and companion performance when carrying out tasks that are critical tasks
timeFrame: At session 6, after an average of 7.5 hours of training.
Secondary outcomes:
measure: Use errors, close calls, and use difficulties
timeFrame: At session 6, after an average of 7.5 hours of training.
measure: SCI user and companion general performance when carrying non-critical tasks
timeFrame: At session 6, after an average of 7.5 hours of training.
measure: Readability and clarity of Instructions for Use (IFU)
timeFrame: At session 5, after an average of 6 hours of training.
measure: SCI user and companion opinion on the accompanying documents and training
timeFrame: At session 6, after an average of 7.5 hours of training.
Other outcomes:
measure: SCI user and companion satisfaction and comfort
timeFrame: At session 6, after an average of 7.5 hours of training.
measure: Usability of donning and doffing
timeFrame: At session 6, after an average of 7.5 hours of training.
measure: Functional test with the exoskeleton
timeFrame: At session 6, after an average of 7.5 hours of training.
measure: SCI user fitting within the device
timeFrame: Through study completion, an average of 9 hours of training and assessment.
measure: Frequency and type of exoskeleton imbalances corrected by the safety rail and by the companion
timeFrame: Through study completion, an average of 9 hours of training and assessment.
measure: Assistance provided by the companion during device use
timeFrame: At session 6, after an average of 7.5 hours of training.
Locations:
city: Paris
country: France
facility: Wandercraft
Study officials:
affiliation: Wandercraft
name: Rebecca Sauvagnac, MD
role: PRINCIPAL_INVESTIGATOR
References: