Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia

Completed

• Conditions: Spinal Cord Injury; Tetraplegia/Tetraparesis; Paraplegia, Complete; Paraplegia, Incomplete; Guillain Barré Syndrome

• Registration Number: NCT06939634
• Lead Sponsor: Wandercraft

Brief Summary

The objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• ≥18 years old,
• Tetraplegia or high paraplegia (at or above T4) regardless of the cause,
• Non-opposition to the participation to the study,
• Having undergone a minimum of 1 session with the Atalante device from February 2019, to now.

Exclusion Criteria

• Neurological Level of Injury below T4 as determined by the International Standards for Neurological Classification of SCI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety through the collection of the reported adverse device effects	Baseline, up to 101 weeks.	Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).

Secondary Outcome Measures

Name	Time	Method
Walking speed	Baseline, post-intervention (up to 101 weeks)	This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace.
Mobility, balance, walking ability, and fall	Baseline, post-intervention (up to 101 weeks)	This may involve Time Up and Go (TUG), a timed task where the patient is asked to stand up from the chair, walk 3 meters, turn around, walk and sit again.
Endurance	Baseline, post-intervention (up to 101 weeks)	This may involve 6-minutes' walk test (6MWT) and 2-minutes' walk test (2MWT) measuring the walked distance during a 6- or 2-minutes' walk.
Balance	Baseline, post-intervention (up to 101 weeks)	This may involve Berg Balance Scale (BBS) including items include static and dynamic activities of varying difficulty.
Independance	Baseline, post-intervention (up to 101 weeks)	This may involve Spinal Cord Independence Measure (SCIM III) including items assessing self-care, respiration and sphincter management.
Usability assessment	Post-intervention (up to 101 weeks)	The assessment of the usability will be asked to the operators in charge of the rehabilitation of the patients included in this study. It includes a usability questionnaire and session data collection.
Spasticity assessment	Baseline, post-intervention (up to 101 weeks)	This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file.
Walking ability	Baseline, post-intervention (up to 101 weeks)	This may involve Walking Index for Spinal Cord Injury, version II (WISCI II) assessing the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI. It ranges from 0 (unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters).

Trial Locations

Locations (3)

Fondation Hopale; 🇫🇷 Berck, France

CMPR de Pionsat; 🇫🇷 Pionsat, France

Hôpital La Musse; 🇫🇷 Saint Sébastien de Morsent, France