Exoskeleton Gait Training in Guillain-Barré Syndrome: Safety, Feasibility, Usability, and Longitudinal Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
研究概览
简要总结
The main objective of the study is to determine if the Atalante X exoskeleton by Wandercraft is a safe, reliable, and usable device for people with Guillain-Barré Syndrome (GBS) who are unable to walk.
The secondary objective is to assess the impact of using this device on the gait and functional recovery of this type of users (GBS).
The users undergo 20 training sessions over 6 weeks. Assessments are carried out at baseline, post-intervention, and at a 4-week follow-up after completing the training sessions. In all assessments, the same outcomes is conducted using the Medical Research Council Outcome, 10-Meter Walk Test, 6-Minute Walking Test, Kansas University Standing Balance Scale, Functional Independence Measure and Level of Assistence. To assess satisfaction, the QUEST 2.0 scale is administered. During this 20 sessions, monitoring is conducted for possible adverse effects that may appear and for the time required for donning and doffing the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Guillain Barre syndrome
- •Receiving outpatient care and admitted at Institut Guttmann
- •Able to provide written informed consent
- •Unable to walk (FAC 0-1).
排除标准
- •Ability to walk >10 m without physical assistance or walking aids
- •History of lower-limb fragility fracture within the previous 2 years
- •Inability to tolerate 30 minutes of standing without clinical symptoms of orthostatic hypotension
- •Psychological or cognitive impairment preventing adherence to study procedures
- •Medical instability or severe comorbidities deemed by a physician to contraindicate participation
- •Skin lesions in areas in contact with the device
- •Anthropometric or anatomical constraints incompatible with the exoskeleton (e.g., height, width, weight, or relevant leg-length discrepancies)
- •Insufficient range of motion (ROM) for safe use of the Atalante™ exoskeleton
- •Known pregnancy or breastfeeding.