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

NCT06939634 | Completed

• 1 other identifier: CIP009
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Keywords

Hands-free Exoskeleton; Atalante X; Atalante; Rehabilitation; Safety

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, up to 101 weeks.

Secondary Outcomes (8)

• Spasticity assessment

  Baseline, post-intervention (up to 101 weeks)

• Walking ability

  Baseline, post-intervention (up to 101 weeks)

• Walking speed

  Baseline, post-intervention (up to 101 weeks)

• Mobility, balance, walking ability, and fall

  Baseline, post-intervention (up to 101 weeks)

• Endurance

  Baseline, post-intervention (up to 101 weeks)

Other Outcomes (10)

• Descriptive data: Age

  Baseline, up to 101 weeks.

• Descriptive data: Gender

  Baseline, up to 101 weeks.

• Descriptive data: Cause and time since injury or pathology

  Baseline, up to 101 weeks.

Study Arms (1)

Hands-free exoskeleton

Patient with high paraplegia or tetraplegia who have undergone at least one session with the exoskeleton.

Device: Hands-free exoskeleton

Interventions

Hands-free exoskeleton DEVICE

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

Hands-free exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population includes people with high paraplegia and tetraplegia.

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (3)

Fondation Hopale

Berck, France, 62600, France

Location

CMPR de Pionsat

Pionsat, France, 63330, France

Location

Hôpital La Musse

Saint-Sébastien-de-Morsent, France, 27180, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Paraplegia; Guillain-Barre Syndrome

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; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: April 23, 2025
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)