Status:
COMPLETED
Effect of the Atalante Exoskeleton on Standing and Walking in Individuals With Paraplegia: A Prospective Controlled-Environment Study in a Rehabilitation Context
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Paraplegia, Complete
Eligibility:
All Genders
18+ years
Phase:
NA
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 individua...
Detailed Description
Background and Rationale Complete paraplegia, resulting from spinal cord injury, is a major neurological condition involving irreversible loss of lower limb function. Given the limitations of neuromot...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06941896
Start Date
January 1 2017
End Date
September 1 2019
Last Update
April 24 2025
Active Locations (1)
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1
CMPR APAJH Pionsat
Pionsat, Auvergne, France, 63330