NCT07170709

Brief Summary

This study aims to investigate how the magnitude of mechanical loading affects reflex latency patterns induced by whole-body vibration (WBV). WBV can trigger two types of reflexes: the tonic vibration reflex (TVR) and the bone myoregulation reflex (BMR), which may be influenced by load-bearing condition. The study will include healthy adult volunteers aged 20-50 years. Reflex responses will be recorded from the soleus muscle using surface EMG during both WBV. Different conditions of mechanical loading (i.e., standing on one foot, both feet) and vibration frequencies (30-36 Hz) will be tested. The main outcome will be the latency of the reflex responses, which will help distinguish between TVR and BMR activation. The goal is to better understand how mechanical load modifies reflex response timing and to characterize the underlying afferent pathways. This knowledge may contribute to optimizing vibration-based rehabilitation strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 29, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 2, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
Last Updated

September 29, 2025

Status Verified

August 1, 2025

Enrollment Period

18 days

First QC Date

August 29, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

Whole-Body VibrationTonic Vibration ReflexBone Myoregulation ReflexReflex LatencyPostural ReflexesSurface ElectromyographyMechanical LoadingHealthy VolunteersNeuromuscular Physiology

Outcome Measures

Primary Outcomes (1)

  • Reflex latency (milliseconds) in the soleus muscle during vibration stimulation

    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.

    Day 1 (single-session, during each experimental condition)

Secondary Outcomes (4)

  • EMG amplitude of reflex response in the soleus muscle during vibration stimulation

    Day 1 (single-session, during each experimental condition)

  • Reflex type classification (TVR vs BMR) based on latency and mechanical load

    Day 1 (single-session, during each experimental condition)

  • Reflex latency variability under different mechanical loading conditions

    Day 1 (single-session, during each experimental condition)

  • Effect of vibration frequency on reflex latency and amplitude

    Day 1 (single-session, during each experimental condition)

Study Arms (1)

Whole-Body Vibration in Healthy Volunteers

EXPERIMENTAL

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.

Device: Whole-Body Vibration

Interventions

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.

Also known as: WBV, Reflex Latency Vibration Protocol
Whole-Body Vibration in Healthy Volunteers

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Istanbul, 34186, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 39119811BACKGROUND
  • 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.

    PMID: 27485766BACKGROUND
  • 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.

    PMID: 28457998BACKGROUND

Study Officials

  • Selim Sezikli, MD

    Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants receive the same sequence of whole-body vibration under different loading conditions. There is no randomization or control group. This is a single-arm, within-subject experimental design evaluating reflex latency under multiple biomechanical scenarios.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator / Physical Medicine & Rehabilitation Specialist

Study Record Dates

First Submitted

August 29, 2025

First Posted

September 12, 2025

Study Start

September 2, 2025

Primary Completion

September 20, 2025

Study Completion

September 24, 2025

Last Updated

September 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Following publication of the main study results, de-identified individual participant data (IPD) and relevant supporting documents will be made available to qualified researchers upon submission of a valid research proposal. Data will be provided exclusively for research purposes and under a formal data sharing agreement.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 6 months after the primary publication and will remain accessible for 5 years. Access will be granted on a case-by-case basis following review of a research proposal and execution of a formal data-sharing agreement.
Access Criteria
Access will be limited to qualified researchers who submit a request for a research project that has received prior ethical approval and who agree to comply with the study's confidentiality principles. Data access will be granted through a formal data-sharing agreement executed between the requesting researcher and the study sponsor or relevant institution. The agreement will specify the intended purpose of data use, the duration of access, and the confidentiality obligations. Shared data will consist of de-identified individual participant data (IPD), with all potentially identifying information removed. Supporting documents such as the study protocol, statistical analysis plan, and analytic code will also be provided to promote research transparency.
More information

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