Trial document



drksid header

  DRKS00012265

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012265
  •   2017/04/04
  •   [---]*
  •   yes
  •   Approved
  •   16/12, Ethikkommission der Universität des Saarlandes
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Parkinson's Disease
  •   Multiple Sclerosis, Apoplex
  •   G20 -  Parkinson disease
  •   G35 -  Multiple sclerosis
  •   I63 -  Cerebral infarction
end of 1:N-Block indications
start of 1:N-Block interventions

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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/04/20
  •   200
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • 66123  Saarbrücken
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • Ms.  M.Sc.  Andrea  Dincher 
    • Uni Campus B8.1
    • 66123  Saarbrücken
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • Ms.  M.Sc.  Andrea  Dincher 
    • Uni Campus B8.1
    • 66123  Saarbrücken
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Sportwissenschaftliches Institut der Universität des Saarlandes
    • 66123  Saarbrücken
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.