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Clinical Trials/NCT02251470
NCT02251470
Completed
Phase 1

The Application of a Video-game System (Nintendo Wii®) as an Independent Exercise Program to Improve Mobility After Stroke - a Randomized Phase II Trial

Martin-Luther-Universität Halle-Wittenberg2 sites in 1 country14 target enrollmentOctober 2014
ConditionsStroke

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Stroke
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Enrollment
14
Locations
2
Primary Endpoint
Feasibility
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

André Golla

André Golla

Martin-Luther-Universität Halle-Wittenberg

Eligibility Criteria

Inclusion Criteria

  • cerebral infarction
  • place of residence: Halle (Saale) and immediate surroundings
  • television in household
  • independent ambulatory (functional ambulation classification \> 3)
  • self-selected walking speed \> 0,4 m/s

Exclusion Criteria

  • Strong visual impairment despite visual aid
  • Deafness / verbal communication is not possible
  • distinct mobility limitations due to comorbidity
  • Body weight \>120kg
  • Cardiac pacemaker
  • Acute psychiatric, disease/dementia

Outcomes

Primary Outcomes

Feasibility

Time Frame: 12-weeks

Recruiting potential, the participants' acceptance/satisfaction of the intervention and economic aspects

Secondary Outcomes

  • Mobility(Baseline - after 6 weeks - after 12 weeks)

Study Sites (2)

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