Trial document
DRKS00012265
Trial Description
Title
Effects of whole body vibration in the elderly and in neurologic disorders
Trial Acronym
[---]*
URL of the Trial
[---]*
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.
Brief Summary in Scientific Language
Effects of whole body vibration in the elderly and in neurologic disorders
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00012265
- 2017/04/04
- [---]*
- yes
- Approved
- 16/12, Ethikkommission der Universität des Saarlandes
Secondary IDs
- [---]*
Health Condition or Problem studied
- Parkinson's Disease
- Multiple Sclerosis, Apoplex
- G20 - Parkinson disease
- G35 - Multiple sclerosis
- I63 - Cerebral infarction
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
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- patient/subject, assessor
- Placebo, Active control (effective treament of control group)
- Treatment
- Parallel
- III
- N/A
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
Secondary Outcome
[---]*
Countries of Recruitment
- Germany
Locations of Recruitment
- other
Recruitment
- Actual
- 2017/04/20
- 200
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
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
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
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-sponsorstart 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-contactstart of 1:1-Block address contact scientific-contact- 06813022534
- [---]*
- andrea.dincher at uni-saarland.de
- [---]*
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-contactstart of 1:1-Block address contact public-contact- 06813022534
- [---]*
- andrea.dincher at uni-saarland.de
- [---]*
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*