Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Performance of Upper Limbs scale (PUL)
研究概览
简要总结
The study is a feasibility study or pilot study, that is a clinical investigation to acquire the preliminary information on a motorized exoskeleton (BRIDGE / EMPATIA exoskeleton) for the movement of the upper limb in order to develop it, including design changes. The primary objective of the clinical trial is to assess the fit, safety and usability of the device in supporting the execution of daily activities for patients suffering from muscular dystrophy. The risk analysis for the BRIDGE / EMPATIA device does not present particular criticalities that preclude the use of the device in the target population. In any case, during the trial eventual adverse events are recorded for the verification of safety..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group
Each participant is evaluated while wearing or not wearing the device.
干预措施: BRIDGE/EMPATIA exoskeleton (Device)
结局指标
主要结局
Performance of Upper Limbs scale (PUL)
时间窗: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
The PUL includes 22 items with an entry item to define the starting functional level and 21 items subdivided into shoulder level (4 items), middle level (9 items) and distal level (8 items). For weaker patients, a low score on the entry item means high-level items do not need to be performed. Each dimension can be scored separately with a maximum score of 16 for the shoulder level, 34 for the middle level and 24 for the distal level. A total score can be achieved by adding the three level scores, with a maximum global score of 74. The lower the score, the higher the disability. Pane et al., Reliability of the Performance of Upper Limb assessment in Duchenne muscular dystrophy, Neuromuscular disorders 2014, 24:201-206.
次要结局
- System usability scale (SUS)(Within 15 days from the baseline)
- ABILHAND(Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.)
- Technology acceptance model (TAM) questionnaire(Within 15 days from the baseline)
研究者
Alessandra Pedrocchi
Professor
Politecnico di Milano