NCT06939634已完成不适用
Evaluation of Usability and Safety of the System Atalante in Patients With High Paraplegia and Tetraplegia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Wandercraft
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Safety through the collection of the reported adverse device effects
研究概览
简要总结
The objective of this clinical trial is to determine whether the Atalante X exoskeleton can be safely utilized by patients with tetraplegia and high paraplegia (at or above T4).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •≥18 years old,
- •Tetraplegia or high paraplegia (at or above T4) regardless of the cause,
- •Non-opposition to the participation to the study,
- •Having undergone a minimum of 1 session with the Atalante device from February 2019, to now.
排除标准
- •Neurological Level of Injury below T4 as determined by the International Standards for Neurological Classification of SCI
结局指标
主要结局
Safety through the collection of the reported adverse device effects
时间窗: Baseline, up to 101 weeks.
Measured through all reported adverse device effects (ADEs). ADEs are categorized into the following categories: musculoskeletal, cutaneous (skin abrasion), cardiovascular (orthostatic hypotension), pain, falls, and fractures and are further characterized as minor or serious based on the nature and the severity of the adverse event (AE).
次要结局
- Walking speed(Baseline, post-intervention (up to 101 weeks))
- Mobility, balance, walking ability, and fall(Baseline, post-intervention (up to 101 weeks))
- Endurance(Baseline, post-intervention (up to 101 weeks))
- Balance(Baseline, post-intervention (up to 101 weeks))
- Independance(Baseline, post-intervention (up to 101 weeks))
- Usability assessment(Post-intervention (up to 101 weeks))
- Spasticity assessment(Baseline, post-intervention (up to 101 weeks))
- Walking ability(Baseline, post-intervention (up to 101 weeks))
研究者
研究点 (3)
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