Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Lateral hip movement
研究概览
简要总结
The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective).
Primary study endpoints will be a significantly higher rated patient comfort and or patient satisfaction using the new versions, compared with the established Lokomat. Furthermore, muscle activity and kinematic movement patterns will be expected to show more involved muscle groups and a walking pattern involving more degrees of freedom during use of the new version compared with the established Lokomat.
Exploratory endpoints will be a significantly stronger involvement of muscles needed for balance, more physiological walking patterns and more change on the lateral positioning of the feet due to training with the new version, compared with the established Lokomat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 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
- •Lower extremity weakness due to stroke
- •minor functional impairment (MRC < 5)
- •ability and willingness to participate
排除标准
- •severe spasticity of the lower extremities
- •severe dementia
- •severe depression
- •any other contraindications against Lokomat training
- •body weight > 135 kg
研究组 & 干预措施
Lokomat Pro
gait robot established on the market
干预措施: Gait training with Lokomat Pro (Behavioral)
Lokomat Pro FreeD
gait robot based on the Lokomat Pro with changes in guidance of the hip, approved for the Swiss market
干预措施: Gait training with Lokomat Pro FreeD (Behavioral)
结局指标
主要结局
Lateral hip movement
时间窗: 30 min training during day 1 (next session after inclusion)
during 30 min training with each device, lateral hip movements will be assessed
次要结局
- Patient motivation(day 2 and 3)
- Patient satisfaction(day 2 and 3)