Stroke Clinical Trial
Official title:
The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial
BACKGROUND: Virtual gaming systems offer new possibilities for home-based exercises (HBE) in
rehabilitation. Pilot studies with stroke patients indicate that the application of Nintendo
Wii® (WII) is practicable and can improve balance under clinical conditions. However, larger
trials are necessary to verify these positive effects after discharge from the hospital.
AIM: This study aims to prepare and optimize a phase III trial which compares the effects of
two HBE programs for stroke patients.
METHODS: A pilot study with randomized control design and repeated measures over
three-months will be conducted. Twenty elderly stroke patients will be randomly allocated to
an experimental group (EG) and a control group (CG). All participants will receive an
introduction to a HBE program by an individual mentoring over 6 weeks. During the following
6 weeks the participants perform the HBE on their own. The EG will perform a balance
exercise program using the WII, the CG will perform a balance exercise program without
technical support.
Recruiting potential, the participants' acceptance of the intervention and economic aspects
will be examined. Additionally, basic information about sensitivity of change and potential
effect sizes regarding the proposed instruments to measure mobility are expected.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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