Effect of the Atalante Exoskeleton on Standing and Walking in Individuals With Paraplegia: A Prospective Controlled-Environment Study in a Rehabilitation Context

NCT06941896 | Completed

• 1 other identifier: 2016-A01221-50
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aims to evaluate the feasibility, safety, and acceptability of the Atalante robotic exoskeleton, developed by Wandercraft, within a functional rehabilitation protocol for individuals with complete paraplegia. Unlike re-education, which focuses on restoring impaired functions, rehabilitation seeks to promote long-term autonomy despite persistent impairments. The study would involve adult participants with complete spinal cord injury-induced paraplegia. Each participant would follow an intensive program of 60 sessions over six weeks, including phases of verticalization, postural stabilization, and assisted locomotion. The protocol would include three evaluation domains: (1) biomedical safety (orthostatic tolerance, adverse events, metabolic load), (2) techno-functional usability (setup time, technical incidents), and (3) user-perceived trust (comfort, sense of safety, satisfaction). The primary objective would be to determine whether the Atalante exoskeleton can be safely and repeatedly used by individuals with complete paraplegia without requiring manual support. The study would also aim to identify potential barriers to its integration into an intensive rehabilitation protocol. The expected outcomes could guide clinical practices and help define optimal inclusion criteria for the safe and effective use of this technology.

Conditions

Paraplegia, Complete

Keywords

exoskeleton; Atalante; paraplegia; rehabilitation; safety

Outcome Measures

Primary Outcomes (1)

• Adverse events related to the use of the Atalante exoskeleton

  Evaluation of biomedical safety through systematic recording of adverse events (serious and non-serious) occurring during the training program, including but not limited to: fractures, dermabrasions, orthostatic hypotension, joint or muscle pain.

  At each session, through study completion (6 weeks total)

Secondary Outcomes (10)

• Evolution of oxygen consumption during assisted locomotion

  Session 21 (week 3) and session 60 (week 6)

• Evolution of transport cost during assisted locomotion

  Session 21 (week 3) and session 60 (week 6)

• Evolution of perceived exertion during assisted locomotion

  Session 21 (week 3) and session 60 (week 6)

• Perceived general comfort during use of the Atalante exoskeleton

  At each session, through study completion (6 weeks total)

• Perceived thoracic comfort during use of the Atalante exoskeleton

  At each session, through study completion (6 weeks total)

Study Arms (1)

Exosquelette Atalante

EXPERIMENTAL

Device: Use of the Atalante Exoskeleton

Interventions

Use of the Atalante Exoskeleton DEVICE

Assisted verticalization (sit-to-stand transition) Orthostatic stabilization (unsupported standing posture) Assisted locomotion (stabilized walking)

Exosquelette Atalante

Eligibility Criteria

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

You may qualify if:

• Complete spinal cord injury (ASIA A classification)
• Lesion level at or below T6
• Injury occurred more than 6 months prior to enrollment (chronic/stabilized injury)
• Ability to maintain upright posture without symptomatic orthostatic hypotension
• Joint range of motion compatible with wearing the exoskeleton
• Anthropometric dimensions compatible with the device, including:
• Body weight less than 90 kg

You may not qualify if:

• Spasticity greater than 3 on the Modified Ashworth Scale
• Joint limitations incompatible with exoskeleton use
• Spinal instability
• Cognitive or psychiatric disorders affecting protocol adherence
• Recent dermatological conditions
• History of fragility fractures in the lower limbs within the past 2 years
• Presence of 5 or more fracture risk factors according to Craven et al., including:
• Injury older than 10 years
• Thoracic-level lesion
• Absence of regular weight-bearing activity
• Low spasticity
• Body Mass Index (BMI) \< 20
• Cardiopulmonary contraindications to physical effort
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CMPR APAJH Pionsat

Pionsat, Auvergne, 63330, France

Location

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No blinding was applied, as all participants and investigators were aware of the intervention during the sessions.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, Specialist in Physical and Rehabilitation Medicine, CHU de Nîmes; Research Affiliate, Euromov Laboratory, University of Montpellier

Model Details: All participants will receive the same intervention: the use of the Atalante exoskeleton for assisted standing and walking during rehabilitation. There is no control group.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 24, 2025
• Study Start: January 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)