A Phase 1/2 interventional study of HBE Wii (EG) and HBE Control (CG) in Stroke, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 2 sites in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2015-12-02.
Sponsored by Martin-Luther-Universität Halle-Wittenberg · Phase 1/2, Interventional, and Supportive care
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 14 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants receive an introduction of using the Nintendo Wii by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (wii-fit balances games) at home (instruction: min. 3 times a week for each 30 minutes).
Other: HBE Wii (EG)
Participants receive an introduction for conventional/traditional balance exercise by an individual mentoring for over 6 weeks (a total of 6 sessions á 60 minutes). During the following 6 weeks the participants perform the balance exercise program (exercises in standing and walking) at home (instruction: min. 3 times a week for each 30 minutes).
Other: HBE Control (CG)
Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
Feasibility
Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects
Time frame: 12-weeks
Mobility
Berg Balance Scale, Dynamic Gait Index, Timed Up and Go (TUG) Test, Activities-Specific Balance Confidence Scale
Time frame: Baseline - after 6 weeks - after 12 weeks
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Martin-Luther-Universität Halle-Wittenberg