Clinical Trial ROBERT® - Project Active Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed
研究概览
简要总结
The overall purpose with this clinical trial is to, monitor and secure ROBERT®'s clinical performance and safety in a clinical environment in the regional hospital North Denmark, Neuro Unit North. The purpose of the study is to investigate if ROBERT® has the ability to 1. Perform guided active training. 2. Perform resistance based active training. And validate the safety of ROBERT® in a clinical environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Hospitalised patients at Neuro Unit North, during the trial period.
- •18 years or older.
- •Can read, understand and speak Danish
- •Reduced motor function in lower extremities.
排除标准
- •No able to sign informed consent.
- •Cannot read, understand or speak Danish
- •Patients with unstable fractures in columna, pelvis or lower extremities.
- •Patients with the risk of ulcers, or with exceedingly sensitive skin.
- •The patient is refusing to train with ROBERT®
结局指标
主要结局
Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed
时间窗: Up to 19 weeks
1. Active training capabilities will be assessed, 3 active motions are planned (the therapist has to be active) by the therapist, and manually performed by hand. The resistance perceived by the therapist is then compared to the expert opinion of the therapist to evaluate if this correlates with, small, medium, and large resistance. This is evaluated as passed/not passed for all 3 motions 2. Active assistive training capabilities will be assessed: 3 passive motions are planned (the robot moves, the therapist follows movement), by the therapist and the robot starts performing the motions, the therapist performs a small, moderate and large assistive movement in conjunction with the robot. The results in % of activity in the path of motion are displayed, and the therapist evaluates if this is in agreement with what they would categorise as a small, moderate and large assistive movement respectively. This is evaluated as passed/not passed for all 3 motions.
Safety, Capture adverse events.
时间窗: Up to 19 weeks
Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions.
次要结局
未报告次要终点