Controlled clinical trial investigating the efficacy of physiotherapy compared to treatment with the Nintendo Wii game console for the improvement of balance in patients with stroke

Not Applicable

Recruiting

Conditions: I64
R42
I69.3
Stroke, not specified as haemorrhage or infarction
Dizziness and giddiness
Sequelae of cerebral infarction

Registration Number: DRKS00003168

Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

• cerebral infarction within the last 6 months, previously ambulatory
• aged between 18 and 90 years
• able to stand with assistance/therapeutic appliances

Exclusion Criteria

• Strong vision impairment = 0.5 in less impaired eye
• Deafness / verbal communication is not possible
• Unstable fractures or severe osteoarthritis/arthritis of the lower extremity
• polyneuropathy with sensory (<4/8 malleolär) or motor deficits
• Other concomitant diseases, relevant for balance (e.g. peripheral paresis)
• Body weight >150kg
• Epilepsy
• Cardiac pacemaker
• Psychiatric disease/dementia

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is measured with the BBS: Berg Balance Scale.<br>This is a test battery consisting of motor tests to determine balance and risk of falling.<br>Primary endpoint is either 4 weeks after end of treatment, or - if earlier - at discharge from hospital.<br>The primary parameter is the change in the value of the Berg Balance Scale before, immediately after and 4 weeks after end of therapy.

Secondary Outcome Measures

Name	Time	Method
COP measurement: Measurement of body pressure point in the upright position, change of ability to regulate posture before/after therapy<br><br> TUG: Timed Up and Go test. Test checks the understanding of a simple everyday task, the ability to stand up alone, to walk 3 meters, turn around and sit down (time tracking)<br><br> MFAS: Motor Function Assessment Scale. Capture of patients' motor function in 44 sub-items (sitting, standing up and standing, walking and function of the upper extremities)<br><br> FIM: Functional Independence Measure. Test for the assessment of needs and autonomy of patients in everyday life<br><br> Questions about the fall/therapy frequency<br> Standardized questions about the frequency of falls, the incidence of self-induced additional therapy and satisfaction with the therapy.<br><br>Secondary endpoint is either 4 weeks after end of treatment, or - if earlier - at discharge from hospital.