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

NCT06941896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-04-24

No results posted yet for this study

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

Interventions

DEVICE

Use of the Atalante Exoskeleton

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941896 on ClinicalTrials.gov