Human Factors Validation Testing of the Wandercraft Personal Exoskeleton

NCT06715631 | Completed

• 1 other identifier: CIP010
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Tetraplegia; Paraplegia

Keywords

Spinal Cord Injuries; Robotics; Community use; Hands-free exoskeleton; Overground exoskeleton; Walking; Self-balancing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Use errors, close calls, and use difficulties

  At session 6, after an average of 7.5 hours of training.

• SCI user and companion general performance when carrying non-critical tasks

  At session 6, after an average of 7.5 hours of training.

• Readability and clarity of Instructions for Use (IFU)

  At session 5, after an average of 6 hours of training.

• SCI user and companion opinion on the accompanying documents and training

  At session 6, after an average of 7.5 hours of training.

Other Outcomes (6)

• SCI user and companion satisfaction and comfort

  At session 6, after an average of 7.5 hours of training.

• Usability of donning and doffing

  At session 6, after an average of 7.5 hours of training.

• Functional test with the exoskeleton

  At session 6, after an average of 7.5 hours of training.

Study Arms (1)

Hands-free exoskeleton

EXPERIMENTAL

Device: Hands-free exoskeleton

Interventions

Hands-free exoskeleton DEVICE

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.

Hands-free exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (1)

Wandercraft

Paris, 75004, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rebecca Sauvagnac, MD

  Wandercraft

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: December 4, 2024
• Study Start: August 20, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

FR (1)