- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07170709
- Original Trial
WBV Reflex Latency and Mechanical Load (WBV-BMR)
Effect of Mechanical Load Magnitude on Reflex Latency Induced by Whole-Body Vibration: A Latency-Based Evaluation of Bone Myoregulation Reflex and Tonic Vibration Reflex
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study investigates how the magnitude of mechanical loading alters reflex latency patterns during whole-body vibration (WBV), focusing specifically on the tonic vibration reflex (TVR) and the bone myoregulation reflex (BMR). Experimental data suggest that WBV may activate different reflex mechanisms depending on the level of postural loading, frequency, and amplitude of the vibration. Previous studies have shown that low-amplitude WBV tends to activate TVR under voluntary contraction, while higher mechanical loads and neutral standing posture are more likely to induce BMR.
Surface electromyography (sEMG) recordings will be obtained from the soleus muscle during vibration stimuli applied at different frequencies (30, 32, 34, and 36 Hz). Recordings will be taken under multiple loading conditions: standing on both feet, standing on one foot. Reflex latency will be calculated using cumulative averaging techniques, and data will be analyzed offline using Spike2 software.
Findings from this study may contribute to a deeper understanding of reflex integration during vibratory stimulation and inform future neurorehabilitation protocols that utilize WBV as a therapeutic modality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34186
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 40 years
- Healthy adult volunteers with no known neurological or musculoskeletal disorders
- Able to provide informed consent
- Willing to comply with the procedures of the study, including EMG and vibration exposure
Exclusion Criteria:
- History of any neurological condition (e.g., peripheral neuropathy, spinal cord injury, stroke)
- Musculoskeletal injury or surgery involving the lower extremities
- Use of medications affecting neuromuscular function
- Pregnancy
- Presence of implanted electronic devices (e.g., pacemaker)
- Known intolerance to vibration exposure
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: Whole-Body Vibration in Healthy Volunteers
Participants will receive whole-body vibration (WBV) under mechanical loading conditions.
Surface EMG recordings from the soleus muscle will be used to evaluate reflex latency at vibration frequencies of 30, 32, 34, and 36 Hz.
All interventions will be applied in a single-session experimental design in healthy adult volunteers.
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Participants will receive whole-body vibration (WBV) at 30-36 Hz under different mechanical loading conditions (e.g., standing on one foot, both feet,).
Vibration-induced reflex responses will be recorded from the soleus muscle using surface electromyography.
The intervention is designed to evaluate latency differences between tonic vibration reflex (TVR) and bone myoregulation reflex (BMR) under controlled biomechanical scenarios.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reflex latency (milliseconds) in the soleus muscle during vibration stimulation
Time Frame: Day 1 (single-session, during each experimental condition)
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Reflex latency will be calculated based on surface EMG recordings from the soleus muscle during whole-body vibration at frequencies of 30-36 Hz.
Latency will be analyzed using cumulative averaging techniques and expressed in milliseconds.
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Day 1 (single-session, during each experimental condition)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reflex type classification (TVR vs BMR) based on latency and mechanical load
Time Frame: Day 1 (single-session, during each experimental condition)
|
Reflex responses will be categorized as tonic vibration reflex (TVR) or bone myoregulation reflex (BMR) based on latency values and mechanical loading condition.
Classification will be supported by comparisons of reflex latency and EMG suppression patterns across experimental conditions.
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Day 1 (single-session, during each experimental condition)
|
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Reflex latency variability under different mechanical loading conditions
Time Frame: Day 1 (single-session, during each experimental condition)
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Variability in reflex latency will be assessed across different postural load conditions (e.g., single-leg, double-leg, prone) to determine how load magnitude influences the consistency of reflex timing.
Standard deviation and coefficient of variation will be calculated for each condition.
|
Day 1 (single-session, during each experimental condition)
|
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Effect of vibration frequency on reflex latency and amplitude
Time Frame: Day 1 (single-session, during each experimental condition)
|
Reflex latency and EMG amplitude will be compared across vibration frequencies (30, 32, 34, and 36 Hz) to investigate frequency-dependent modulation of neuromuscular responses in the soleus muscle.
|
Day 1 (single-session, during each experimental condition)
|
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EMG amplitude of reflex response in the soleus muscle during vibration stimulation
Time Frame: Day 1 (single-session, during each experimental condition)
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The magnitude of EMG response during whole-body vibration will be recorded from the soleus muscle.
Reflex amplitude differences will be analyzed across various postural loading conditions to evaluate suppression or facilitation effects.
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Day 1 (single-session, during each experimental condition)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Selim Sezikli, MD, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Publications and helpful links
General Publications
- Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.
- Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.
- Karacan I, Turker KS. Exploring neuronal mechanisms of osteosarcopenia in older adults. J Physiol. 2024 Aug 9. doi: 10.1113/JP285666. Online ahead of print.
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WBV-BMR-2025-01
- 2017.124.IRB2.038 (Other Identifier: Koç University IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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