- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05209945
Whole Body Vibration and Tonic Vibration Reflex
High-Frequency Whole Body Vibration Activates Tonic Vibration Reflex
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Seven healthy recreationally active males between the ages of 26 and 35 volunteered to participate in this study. All subjects received pre-study informed consent. All experimental procedures were designed with the Helsinki declaration in mind and approved by the local ethics committee. All subjects performed a familiarization trial to acclimate subjects to the WBV stimulus. WBV-IR and TVR latency of soleus muscle were then measured in the quiet standing position. The vibrations (WBV or tendon) sequence were applied randomly to negate any order/time effect. The subject rested for five minutes between the WBV and tendon vibration. The WBV application was delivered using a PowerPlate Pro5 device (PowerPlate International, Amsterdam, The Netherlands). First, 30 Hz, low amplitude (1 mm) vibration with a duration of 30 seconds was applied to each subject for familiarization purposes. After three minutes of rest, low-amplitude (1 mm) WBV testing was performed in random order in quiet standing positions. In a WBV set, three different vibration frequencies (30, 35, and 40 Hz), each lasting for 30 s with 3-s rest intervals, were delivered. The local vibration was applied to the mid-point of the right Achilles tendon by using a custom-made vibrator. The head of the tendon vibrator was in light contact with the underlying skin. Tendon vibrations were applied by the same researcher. Three different vibration frequencies (100, 135, and 150 Hz) were delivered, lasting for 30 s with 3-s rest intervals. A local vibration was applied to the right heel using the same custom-made vibrator. Tendon vibrations were applied by the same researcher. Three different vibration frequencies (100, 135, and 150 Hz) were delivered, lasting for 30 s with 3-s rest intervals.
The surface electromyography (SEMG) recorded from the soleus and acceleration data were collected simultaneously using data acquisition and analysis system (PowerLab ® software, ADInstruments, Oxford, UK). Disposable self-adhesive bipolar Ag/AgCl (Covidien Kendall, Dublin, Ireland) surface electrodes were placed on the right soleus belly 4 cm apart. The skin overlying the muscle was shaved, light abrasion was applied, and the skin was cleaned with alcohol to reduce the skin resistance. To determine TVR latency, a light (2.9 g) piezoelectric accelerometer (LIS344ALH, ECOPACK®, Mansfield, TX, USA) was firmly fixed using adhesive tape on the skin overlying the right Achilles tendon. To determine WBV-IR latency, an identical accelerometer was firmly mounted on the WBV platform. The acceleration and SEMG signals were recorded at a sampling frequency of 20 kHz. Accelerometer recordings were filtered with a high-pass filter set at 5 Hz. SEMG data obtained during WBV were bandpass filtered at 80-500 Hz to reduce vibration-induced movement artifacts and then full-wave rectified. Similarly, SEMG data obtained during tendon vibration were bandpass filtered at 160-500 Hz and then full-wave rectified. WBV-IR and TVR latencies were then calculated by using the cumulative average method.
An electronic reflex hammer (Elcon, Germany) was used to determine T-reflex latency. All latencies were normalized to the body height of each participant.
Latency was expressed as milliseconds (ms).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34173
- Istanbul Physical Medicine Rehabilitation Training & Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
Exclusion Criteria:
- Scar, dermatitis, etc. in the skin tissue
- Kidney stone history
- Fracture in the lower extremity, history of orthopedic surgery
- Heart disease, Hypertension
- Dizziness
- Metabolic bone diseases, including osteoporosis
- History of bone occupying lesion, neoplasia, osteomyelitis
- Degenerative, inflammatory diseases of the joints of the lower extremities
- Lower extremity thrombophlebitis
- Lower extremity motor loss, sensory loss, muscle atrophy
- Subjects who cannot tolerate whole-body vibration
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vibration
Vibration (WBV, heel, and tendon vibration) was applied to participants
|
whole-body vibration, heel and soleus tendon vibrations were applied to the human body
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WBV-IR latency
Time Frame: during intervention, an average of 1 minute
|
Whole-body vibration induced reflex latency
|
during intervention, an average of 1 minute
|
|
TVR latency
Time Frame: during intervention, an average of 1 minute
|
Tonic vibration reflex latency
|
during intervention, an average of 1 minute
|
|
Heel vibration induced reflex latency
Time Frame: during intervention, an average of 1 minute
|
Vibration was applied to the right heel.
The reflex latency induced by the heel vibration was measured.
|
during intervention, an average of 1 minute
|
|
T-reflex latency
Time Frame: during intervention, an average of 1 minute
|
Latency of the Achilles tendon reflex
|
during intervention, an average of 1 minute
|
Collaborators and Investigators
Investigators
- Study Chair: İLHAN KARACAN, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WBVTVR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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