SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change from baseline in Timed Up-and Go Test
研究概览
简要总结
Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with sensory ataxia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Assessment, motor training, data analyzes and group allocation are done by different persons. Participants as well as the assessor, the trainer and the investigator are blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Electrophysiological diagnosis of sensory ataxia
- •Age >= 18, <=80
- •Existing declaration of consent
排除标准
- •Pregnancy
- •Lacking capacity for consent
研究组 & 干预措施
Stimulation
During motor training participants in the stimulation arm receive vitro-tactile feedback applied to the feet when touching an object as measured by force-sensing resistors mounted to the sole of the feet.
干预措施: Vibro-tactile stimulation (Device)
Control
The control group receives the same motor training with the same derives (force-sensing resistors, vibro-tactile stimulators) mounted to the feet but receives no stimulation.
干预措施: Placebo Control (Other)
结局指标
主要结局
Change from baseline in Timed Up-and Go Test
时间窗: One day before (baseline) and one day after seven days of motor training
The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling.
次要结局
- Change from baseline in Berg-Balance-Scale(One day before (baseline) and one day after seven days of motor training)
- Change from baseline in 10-Meter-Walk Test(One day before (baseline) and one day after seven days of motor training)
- Change from baseline in Postural-Sway Test(One day before (baseline) and one day after seven days of motor training)