Stroke Clinical Trial
Official title:
Video-based Training for Rehabilitation of Upper Limb Functions After Stroke: a New Treatment Exploiting the Mirror Neuron System
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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