- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07408570
FREQUENCY-DEPENDENT SOLEUS REFLEX MODULATION DURING WHOLE-BODY VIBRATION
FREQUENCY- DEPENDENT MODULATION OF SOLEUS REFLEX RESPONSES DURING WHOLE BODY- VIBRATION IMPLICATIONS FOR PORPELASTIC BOBE MYOREGULATION UNDER GRAVITATIONAL LOADING
Exposure to microgravity leads to pronounced impairments in neuromuscular control, postural stability, and spinal reflex regulation that cannot be attributed to muscle atrophy alone. Rather, these deficits point to a disruption of load-dependent sensorimotor mechanisms and highlight the essential role of gravitational loading of the skeleton as a critical source of sensory input for spinal motor control.
Spinal reflex behavior during upright stance has traditionally been explained primarily by muscle spindle-mediated pathways. However, this framework does not fully account for the reflex alterations observed under conditions of altered mechanical loading, including microgravity, prolonged unloading, or exposure to vibration. In parallel, advances in bone biology have identified osteocytes within the lacuno-canalicular system as highly sensitive mechanosensors that preferentially respond to dynamic loading and changes in strain rate. This insight has given rise to the concept of bone myoregulation, in which bone-derived mechanosensory signals contribute to the modulation of spinal excitability.
A defining characteristic of this process is the poroelastic nature of bone tissue. As a fluid-saturated porous medium, bone exhibits frequency-dependent mechanical behavior, such that oscillatory loading modifies both the temporal profile and magnitude of interstitial fluid flow within the lacuno-canalicular network. As a result, loading frequency is expected to influence not only the timing of reflex responses but also their amplitude. Whole-body vibration offers a controlled experimental paradigm to probe these frequency-dependent, load-sensitive mechanisms in humans.
Accordingly, the aim of the present study was to identify the whole-body vibration frequency band that most effectively induces soleus reflex responses during quiet standing, considering both reflex latency and response amplitude. Investigators hypothesized that these responses would display frequency-dependent behavior consistent with poroelastic bone-mediated myoregulation and would be modulated by individual anthropometric characteristics, with potential implications for vibration-based countermeasures under altered gravitational loading.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Experimental Procedure At the beginning of the experiment, participants will perform three repetitions of maximal voluntary plantarflexion (heel-rise) to determine maximal electromyographic (EMG) activity of the soleus muscle. These recordings will be used for normalization and reference purposes.
Subsequently, whole-body vibration will be applied at 13 different frequencies ranging from 25 to 49 Hz (25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, and 49 Hz). The order of vibration frequencies will be randomized for each participant to minimize order effects.
Whole-Body Vibration Protocol Participants will stand upright in an anatomically neutral position on the vibration platform and will be allowed to lightly hold the device's handrail to maintain balance without providing mechanical support. Vibration amplitude will be set at 2 mm. Each frequency condition will be applied for 15 s, with a 10 s rest period between trials. All WBV applications will be delivered using a Power Plate Pro5 device (Power Plate International Ltd., UK).
Surface Electromyography Recording Surface electromyography (sEMG) will be recorded from the left soleus muscle using bipolar Ag/AgCl electrodes (Redline®, Istanbul, Türkiye; 10-mm diameter, 4-cm interelectrode distance) aligned with the muscle fibers following appropriate skin preparation (impedance <10 kΩ). The electrodes will be placed over the lateral belly of the soleus muscle, with the ground electrode positioned on the right lateral malleolus. The sEMG signals will be amplified (×1000), band-pass filtered between 10 and 1,000 Hz, and sampled at 5,000 Hz.
EMG signals will be acquired using a CED 1902 Quad System MKIII amplifier and a CED Power 1401 MKII A/D converter and will be recorded with Spike2 software (version 7.20; Cambridge Electronic Design, UK). Signals will be stored for offline analysis. Frequency-domain analysis will be performed using fast Fourier transform (FFT) algorithms implemented in Spike2.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Bahçelievler, Istanbul, Turkey (Türkiye), 34197
- Istanbul Pmr Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adults aged between 20 and 45 years,
- Absence of regular exposure to whole-body vibration (WBV) training.
Exclusion Criteria:
- A history of intolerance to whole-body vibration,
- Vertigo history,
- Any medical or neurological condition that could be exacerbated by vibratory stimulation.
All participants will provide written informed consent prior to participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
|
Whole-Body Vibration Protocol Participants will stand upright in an anatomically neutral position on the vibration platform and will be allowed to lightly hold the device's handrail to maintain balance without providing mechanical support.
Vibration amplitude will be set at 2 mm.
Each frequency condition will be applied for 15 s, with a 10 s rest period between trials.
All WBV applications will be delivered using a Power Plate Pro5 device (Power Plate International Ltd., UK).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. WBV-evoked soleus reflex latency (ms)
Time Frame: 195 seconds
|
Reflex latency will be defined as the time interval between the onset of whole-body vibration and the onset of the reflex-related EMG response in the soleus muscle. EMG onset will be identified as the point at which the rectified EMG signal exceeds the mean baseline activity by more than two standard deviations and remains above this threshold for at least 10 ms. This measure will be used as an index of the temporal dynamics of load-sensitive mechanotransduction, consistent with the poroelastic bone-BMR framework. |
195 seconds
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
2. WBV-evoked soleus reflex amplitude (%MVC)
Time Frame: 195 seconds
|
Reflex amplitude will be quantified as the peak rectified EMG amplitude within the predefined reflex response window following vibration onset and normalized to the maximal voluntary contraction (MVC) obtained during heel-rise trials.
Reflex amplitude will be interpreted as an indicator of the magnitude of the evoked reflex response.
|
195 seconds
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- 2025-78
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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