Trial document



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  DRKS00012265

Trial Description

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Title

Effects of whole body vibration in the elderly and in neurologic disorders

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Long term effects (up to one year) of whole body vibration. Aim of this study is to research the effects of different frequencies, sets, duration, times per week on motor symptoms, gait, mobility, balance, flexibility,... Randomized allocation to treatment or control group. Participants are blinded.

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Brief Summary in Scientific Language

Effects of whole body vibration in the elderly and in neurologic disorders

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012265
  •   2017/04/04
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  •   yes
  •   Approved
  •   16/12, Ethikkommission der Universität des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   Parkinson's Disease
  •   Multiple Sclerosis, Apoplex
  •   G20 -  Parkinson disease
  •   G35 -  Multiple sclerosis
  •   I63 -  Cerebral infarction
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Interventions/Observational Groups

  •   Whole body vibration; different frequencies for treatment groups (6, 12, 18, and 24 Hz), times per week (1, 2, 3, or 4x/week), duration at least 4 weeks up to 1 year
  •   Placebo group: same setting as treatment group, without vibration standing on the platform, other parameters same as treatment group
  •   For all other questions: different frequencies (6, 12, 18, or 24 Hz), times per week (1, 2, 3, or 4x/week), different duration of sets and rests (60 sec/60 sec, 60 sec/120 sec)
  •   A further control group receives a classic program of physiotherapy without platform, times per weef and duration analogous to the treatment group
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Improvement after treatment over a few weeks for balance (Force plate: Sway path, and velocity, body position; Berg Balance Scale), mobility (Timed up and Go), flexibility (Sit and reach),... Measurement before first treatment and 20 minutes after last treatment (after 4, 8, or 12 weeks), then follow-up after 1, 2, and 4 weeks

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/04/20
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Parkinson's Disease (confirmed), Multiple Sclerosis or Apoplex, no matter what duration and severity/stage of the disease; elderly who cannot participate on conventional physical training

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Exclusion Criteria

severe coronary heart disease, acute thrombosis, fracture, or knee or hip prosthesis (for less than 3 months), severe diabetes, arrhythmia, pacemaker, untreated hypertonia, open wounds on the soles

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Addresses

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    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • 66123  Saarbrücken
    • Germany
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    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • Ms.  M.Sc.  Andrea  Dincher 
    • Uni Campus B8.1
    • 66123  Saarbrücken
    • Germany
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    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • Ms.  M.Sc.  Andrea  Dincher 
    • Uni Campus B8.1
    • 66123  Saarbrücken
    • Germany
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Sources of Monetary or Material Support

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    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • 66123  Saarbrücken
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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