- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02468011
Whole Body Vibration Induced Muscle Activity and Effect of the Changes in Length of Soleus Muscle and Angle of Ankle (WBVIMR-SL)
Whole Body Vibration Induced Muscle Activity in Different Position of Lower Extremity: Effect of the Changes in Length of Soleus Muscle and Angle of Ankle
Study Overview
Detailed Description
Eighteen healthy young adult men are planned to include in this study. Surface electrodes will be placed on the right soleus muscle's belly. The electrodes (10-mm in diameter, inter-electrode distance of 20 mm) were arranged in the direction of the muscle fibers. The skin overlying the muscle was shaved, light abrasion was applied, and the skin was cleaned using 70% alcohol.
A piezo-electric accelerometer (LIS344ALH full-scale of ±6 g linear accelerometer, ECOPACK) will be placed on the achilles tendon and a force sensor (FC2331-0000-2000L Compression Load Sensor, France) will be placed under the right heel. All data will be recorded by PowerLab (data acquisition system, ADInstruments, Australia) device. The data were processed offline with a computer. All surface electromyography (SEMG) analyses were conducted using a software (LABCHART7 ver. 7.3.3; POWERLAB System, ADInstruments). All SEMG recordings were 80-500 Hz band-pass filtered. Root-mean-square values (RMS) were calculated from the filtered SEMG signal.
WBV (PowerPlate Pro5) with high amplitude at 35 Hz will be applied. Participants were barefooted, and no sponge or foam was placed between the vibration platform and their feet. Participants will stand in different position with their knees locked during WBV. Their hips and knees were in a neutral position. Positions: Position-1: Upright standing on zero sloping vibration platform Position-2: Standing with 10 degrees ankle dorsiflexion on zero sloping vibration platform Position-3: Standing with 20 degrees ankle plantarflexion on zero sloping vibration platform Position-4: Upright standing on twenty degrees forward inclined vibration platform (angle angle will be 20 degrees ankle plantarflexion) Position-5: Leaning forward while standing on twenty degrees forward inclined vibration platform (angle angle will be neutral) Position-6: Upright standing on 10 degrees backward inclined vibration platform (angle angle will be 20 degrees ankle dorsiflexion) Position-7: Leaning backward while standing on 10 degrees backward inclined vibration platform (angle angle will be neutral) Sequence of the position will be random. Maximal voluntary contraction (MVC) was determined for each subject at the beginning of each position using magnitude of force between heel and vibration platform the when the subject attempted to activate the soleus muscle maximally. Then vibration exposure will be 30 seconds.
The participants were instructed to relax their muscles throughout the recordings during WBV and were trained using electromyographic feedback to this end. WBV may impair the sense of balance and muscles may be activated to restore balance. To overcome this problem, the participants were familiarized with WBV with a 15 s trial session on the WBV device and they were asked to use the handles of the device to secure their balance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy men
- Men with ages varying between 20 and 40 years
- Right-handed men
Exclusion Criteria:
- Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and spine
- Medication that could affect the musculoskeletal system
- Postural abnormalities (scoliosis, kyphosis, etc)
- Systemic diseases (Cardiopulmonary diseases, diabetes mellitus etc)
- Obesity (BMI>30 kg/m2)
- Vertigo / dizziness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Vibration
Whole body vibration with 35 Hz
|
vibration will be applied at 35 Hz
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vibration induced reflex muscle activity level
Time Frame: Four months
|
Four months
|
Collaborators and Investigators
Investigators
- Study Chair: 90 212 4404000 90 212 4404000, MD, Bagcilar Training & Research Hospital
Publications and helpful links
General Publications
- Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
- Pollock RD, Woledge RC, Martin FC, Newham DJ. Effects of whole body vibration on motor unit recruitment and threshold. J Appl Physiol (1985). 2012 Feb;112(3):388-95. doi: 10.1152/japplphysiol.01223.2010. Epub 2011 Nov 17.
- Ritzmann R, Kramer A, Gollhofer A, Taube W. The effect of whole body vibration on the H-reflex, the stretch reflex, and the short-latency response during hopping. Scand J Med Sci Sports. 2013 Jun;23(3):331-9. doi: 10.1111/j.1600-0838.2011.01388.x.
- Sebik O, Karacan I, Cidem M, Turker KS. Rectification of SEMG as a tool to demonstrate synchronous motor unit activity during vibration. J Electromyogr Kinesiol. 2013 Apr;23(2):275-84. doi: 10.1016/j.jelekin.2012.09.009. Epub 2012 Oct 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BEAH FTR-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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