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

Wandercraft35 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Cord Injury Tetraplegia/Tetraparesis Paraplegia, Complete Paraplegia, Incomplete Guillain Barré Syndrome

Interventions

Hands-free exoskeletonDEVICE

Having undergone at least on session with Atalante exoskeleton. Clinical, safety and session data are collected retrospectively.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Fondation Hopale

Berck, France, France

CMPR de Pionsat

Pionsat, France, France

Hôpital La Musse

Saint-Sébastien-de-Morsent, France, France

Outcomes

Primary Outcomes

Safety through the collection of the reported adverse device effects

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).

Time frame: Baseline, up to 101 weeks.

Secondary Outcomes

Spasticity assessment

This may involve the use of the Modified Ashworth Scale or a general description of spasticity recorded in the medical file.

Time frame: Baseline, post-intervention (up to 101 weeks)

Walking ability

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).

Time frame: Baseline, post-intervention (up to 101 weeks)

Walking speed

This may involve 10 meters walk test (10MWT) measuring gait speed during a 10-meter walk during comfortable and rapid pace.

Time frame: Baseline, post-intervention (up to 101 weeks)

Mobility, balance, walking ability, and fall

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.

Time frame: Baseline, post-intervention (up to 101 weeks)

Endurance

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.