SFB TRR 169/A3 (2.FP) Crossmodal Learning in Health and Neurological Disease: Neurocomputational Representation and Therapeutic Application (Task 2-1)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline in Action Research Arm Test (ARAT)
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 stroke.
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
- •Ischemic stroke according to ICD 10 I61-I69
- •Deficit still existing (Rankin score of at least 1 at inclusion)
- •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 vibro-tactile feedback applied to their fingers when touching an object as measured by force-sensing resistors mounted to the fingertips.
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 hands but receives no stimulation.
干预措施: Placebo Control (Other)
结局指标
主要结局
Change from baseline in Action Research Arm Test (ARAT)
时间窗: One day before (baseline) and one day after seven days of motor training
The Action Research Arm Test (ARAT) is a 19 item observational measure to assess upper extremity performance (coordination, dexterity and functioning). Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Scores may range from 0-57 points, with higher points indicating better performance.
Change from baseline in Nine-hole peg Test (NHPT)
时间窗: One day before (baseline) and one day after seven days of motor training
A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible.
次要结局
- Change from baseline in Fugl-Meyer Assessment for upper extremity (FMA-UE)(One day before (baseline) and one day after seven days of motor training)
- Change from baseline in Modified Rankin Scale (mRS)(One day before (baseline) and one day after seven days of motor training)
- Change from baseline in Stroke Impact Scale (SIS)(One day before (baseline) and one day after seven days of motor training)
- Change from baseline in National Institutes of Health Stroke Scale (NIHSS)(One day before (baseline) and one day after seven days of motor training)