NCT07408570

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Nov 2025Jun 2026

Study Start

First participant enrolled

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 26, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

bone myoregulation reflex

Outcome Measures

Primary Outcomes (1)

  • 1. WBV-evoked soleus reflex latency (ms)

    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 Outcomes (1)

  • 2. WBV-evoked soleus reflex amplitude (%MVC)

    195 seconds

Study Arms (1)

experimental group

EXPERIMENTAL

experimental group

Other: whole body vibration

Interventions

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).

experimental group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged between 20 and 45 years,
  • Absence of regular exposure to whole-body vibration (WBV) training.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Pmr Training Hospital

Bahçelievler, Istanbul, 34197, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: * 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CHIEF ASISTANT, PHYSIATRIST

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 13, 2026

Study Start

November 30, 2025

Primary Completion

February 26, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations