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

NCT ID: NCT06939634

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-09-01

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hands-free exoskeleton

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

Hands-free exoskeleton

Intervention Type DEVICE

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

Interventions

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Hands-free exoskeleton

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wandercraft

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Hopale

Berck, France, France

Site Status

CMPR de Pionsat

Pionsat, France, France

Site Status

Hôpital La Musse

Saint-Sébastien-de-Morsent, France, France

Site Status

Countries

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France

Other Identifiers

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CIP009

Identifier Type: -

Identifier Source: org_study_id

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