The study hypothesizes superiority of the video-based training (observation combined with motor exercise, "video") over motor exercise alone ("non-video") and standard rehabilitation ("standard").
The clinical study is a multicenter, open, randomized, controlled, paralleled group trial with three investigative arms. The study recruits at least 375 first stroke patients with certain motoric disabilities that are randomly assigned to either one experimental condition or one of two control conditions. Every individual patient participates for 31 (+/- 1) weeks in the trial (see fig. 1), the whole study is planned to last at least for 3 years. The recruitment and treatment of patients will last for 17 months during the trial. Patients undergo a baseline assessment for screening purposes and during the course of participation three further assessments of primary and secondary efficacy endpoints. These endpoints will refer to the degree of recovered objective and subjective physical abilities due to the experimental treatment in comparison to the control comparators. Studies' hypotheses claim that the experimental treatment will lead to effects on the motoric abilities superior the effects elicited by the control treatments.
Trial Stopped: Problem to recruit sufficient patient number
- Verum group Behavioral
Intervention Desc: video-based training after stroke ARM 1: Kind: Experimental Label: Verum group Description: video-based training after stroke
- Placebo group Behavioral
Intervention Desc: non-video group ARM 1: Kind: Experimental Label: Placebo group Description: non-video group
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Wolf Motor Function Test||31 +/-1 weeks||No|
|Secondary||Quality of Life||31 +/-1 weeks||No|