Trial document





This trial has been registered retrospectively.
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  DRKS00003168

Trial Description

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Title

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

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Trial Acronym

Wii Pilot 2a

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URL of the Trial

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Brief Summary in Lay Language

Many patients after stroke suffer from a gait and balance disorder. A well-functioning balance usually is a precondition for learning to walk again. Improving the balance also increases the probability to regain independence. An important part of treatment is physiotherapy.

In our study we will compare two different types of balance therapy and analyse their effectiveness. The classic physical therapy is compared with a novel therapy.

Patients will be randomly assigned to one of two groups. In the regular physiotherapy treatment for 4 weeks the focus will be set on balance exercises . Over this period 4 times a week group therapy with an experienced therapist will be performed. One group is treated with standard physiotherapy. The other group trained using a novel method of therapy, the Nintendo Wii game console. In both groups the focus is on balance training, i.e. exercises will be conducted primarily for shift of body weight and balance.

Before the first and after the last treatment a therapist will perform balance tests and surveys. 4 weeks after last treatment - alternatively before hospital discharge - measurements will be performed to evaluate long-term effects.

• The novel therapy is the Nintendo Wii game console, which has already proved its benefit for different diseases in previous studies. In this game console you can control the game character by shifting the weight of your body. With these treatment the balance is trained on a "playful" way . Results about the success / failure of the exercise are displayed directly on the screen.

• In the second Group the classical physiotherapeutical balance therapy will be applied. The balance disorder will be treated by using different therapeutical material. These exercises have been adapted to the playful style of the Wii treatment.

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Brief Summary in Scientific Language

Dizziness with vertigo and unsteady gait is one of the most frequently complained symptoms in neurological patients [Brandt 2005]. Cerebellar and cerebral infarction can lead to a severe balance disturance with unsteady gait, developing impairment in daily life. To prevent falls and serious injuries rehabilitation procedures are necessary. Currently available as proven effective standard treatment is the conventional physiotherapy.

In this project the effects of the new Nintendo Wii game console therapy will be investigated. With sports and balance software the balance can be exercised.

The Wii adds important elements for the rehabilitation: visual and audible feedback, the possibility to repeat and increased motivation [Summey 2009].

The following questions should be answered by the study:
• What effect does the "Wii-therapy" in comparison to regular physiotherapy show on balance during standing position in patients with stroke?
• Is the "Wii-therapy" applicable as an additional treatment to physical therapy in the clinical setting?

The trial design is randomized and controlled. 30 inpatients with stroke at the Schoen Clinic Bad Aibling will be recruited. At the time of enrollment these patients are able to stand with or without assistance. Each patient receives daily rehabilitation treatment which includes physiotherapy. Under this regimen the patients receive intensive balance exercises 4 times a week for 4 weeks. Patients are randomly assigned in one of two groups. The first group receives balance training with the Wii Fit workout program on the Balance Board. The second group performs comparable physical therapy balance exercises.

Before the first and after the last treatment a therapist will perform balance tests and surveys to measure changes. 4 weeks after last treatment - alternatively before hospital discharge - measurements will be performed to evaluate long-term effects.
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Brandt T, Strupp M. (2005). General vestibular testing. Clinical Neurophysiology, 116: 406-426
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E. H. Summey (2009). A comparison of recreation therapy intervention using Nintendo Wii (TM) bowling with
participation in a tai chi program on balance, enjoyment, leisure and competence of older adults in a community based setting. Dissertation, Clemson University, 2009, 119 pages, AAT 1473368

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Organizational Data

  •   DRKS00003168
  •   2011/07/15
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  •   yes
  •   Approved
  •   274-10, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   I64 -  Stroke, not specified as haemorrhage or infarction
  •   R42 -  Dizziness and giddiness
  •   I69.3 -  Sequelae of cerebral infarction
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Interventions/Observational Groups

  •   15 patients with balance disorder after stroke.
    Treatment period 4 weeks with 4 sessions group therapy per week .
    Status survey using questionnaires and balance tests before and after treatment phase, 4 weeks after end of therapy, alternative to discharge.

    The therapy is done with the Nintendo Wii game console. In this game console you can control the game character by shifting the weight of your body. In the treatment, the balance is trained on a "playful" way . Results about the success / failure of the exercise are displayed directly on the screen.
  •   15 patients with balance disorder after stroke.
    Treatment period 4 weeks with 4 sessions group therapy per week .
    Status survey using questionnaires and balance tests before and after treatment phase, 4 weeks after end of therapy, alternative to discharge.

    Application of classical physiotherapeutical balance therapy. The balance disorder will be treated by using different therapeutical material. These exercises have been adapted to the playful style of the Wii treatment.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Single blind
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

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

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Secondary Outcome

COP measurement: Measurement of body pressure point in the upright position, change of ability to regulate posture before/after therapy

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)

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)

FIM: Functional Independence Measure. Test for the assessment of needs and autonomy of patients in everyday life

Questions about the fall/therapy frequency
Standardized questions about the frequency of falls, the incidence of self-induced additional therapy and satisfaction with the therapy.

Secondary endpoint is either 4 weeks after end of treatment, or - if earlier - at discharge from hospital.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/06/14
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum der Universität München, Campus Großhadern
    • Mr.  PD Dr. med.  Klaus  Jahn 
    • Marchioninistraße 15
    • 81377  München
    • Germany
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    • Schoen Klinik Bad Aibling
    • Ms.  Carmen  Krewer 
    • Kolbermoorer Str. 72
    • 83043  Bad Aibling
    • Germany
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    • Schoen Klinik Bad Aibling
    • Ms.  Carmen  Krewer 
    • Kolbermoorer Str. 72
    • 83043  Bad Aibling
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.