Study of the Effect of the Atalante Exoskeleton (Wandercraft) on Autonomy in Individuals With Paraplegia Undergoing Rehabilitation (Standing and Walking): A Prospective Uncontrolled Study in a Controlled Environment to Demonstrate Its Physical and Psychosocial Utility.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Adverse events related to the use of the Atalante exoskeleton
研究概览
简要总结
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.
详细描述
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 neuromotor re-education in such contexts, rehabilitation aims to restore autonomy and social participation by leveraging residual capacities and assistive technologies. Robotic exoskeletons represent a promising technological innovation in this domain by offering assisted locomotion that compensates for loss of mobility.
Among these devices, Atalante (Wandercraft, Paris, France) is a next-generation, self-stabilizing exoskeleton designed to enable dynamic walking without manual support, through a fully motorized lower limb system. Unlike conventional devices that require crutches or canes, Atalante provides active stabilization, offering new perspectives in terms of autonomy, safety, comfort, and quality of life.
While the potential benefits of exoskeletons in motor recovery have been explored, their use in a functional rehabilitation context remains under-investigated. This project therefore aims to evaluate the Atalante exoskeleton as an assistive tool for autonomy within a structured intensive protocol in a safe clinical environment.
Primary Objective To evaluate the feasibility, safety, and acceptability of intensive use of the Atalante exoskeleton in a functional rehabilitation context among adults with chronic complete paraplegia.
Secondary Objectives To determine the number of sessions required to reach operational familiarization with the exoskeleton.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No blinding was applied, as all participants and investigators were aware of the intervention during the sessions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Adverse events related to the use of the Atalante exoskeleton
时间窗: At each session, through study completion (6 weeks total)
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.
次要结局
- 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))
- Perceived feeling of safety during use of the Atalante exoskeleton(At each session, through study completion (6 weeks total))
- Participant satisfaction with the Atalante exoskeleton assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) scale(At study completion (week 6))
- Change in donning and doffing time for the exoskeleton(At each session, through study completion (6 weeks total))
- Number of sessions required for functional familiarization with the exoskeleton(Through study completion (up to 6 weeks))
- Frequency and types of technical incidents(At each session, through study completion (6 weeks total))
研究者
Eric Pantera
Principal Investigator, Medical Doctor, Specialist in Physical and Rehabilitation Medicine, CHU de Nîmes; Research Affiliate, Euromov Laboratory, University of Montpellier
Centre Hospitalier Universitaire de Nīmes