CClinicalTrials.gg
Status unknownNCT03016286Updated Jul 13, 2017

Bone Myoregulation Reflex & Presynaptic Ia Inhibition

An interventional study of vibration in Effects of Vibration, sponsored by Bagcilar Training and Research Hospital. Status unknown. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-13.

Sponsored by Bagcilar Training and Research Hospital · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Male
01

Study summary

Hypotheses of this study are

  1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body vibration (WBV)
  2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this study is to test these hypotheses.

Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at 35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20 minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of the right ankle, and during WBV respectively.

Read the detailed description

Hypotheses of this study are

  1. Bone myoregulation reflex (BMR) inhibits presynaptically T-reflex during whole-body vibration (WBV)
  2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus T-reflex Aim of this study is to test these hypotheses.

Methods:

Participants:

Ten young, healthy and right hand dominant male adult volunteers will be included in this study.

Procedure:

Prior to the induction of WBV, control T-reflex recordings will be elicited and then the participants will complete a 15-s trial WBV protocol to familiarize themselves with the procedure. Following the control T-reflex recordings, the trial protocol and a 15-s rest, the participants will receive one session WBV. T-reflex will be recorded during WBV. Then, cold pack will be applied to the right ankle for 20 minutes. T-reflex will be recorded during the cooling of the ankle. Then, the participants will receive one session WBV, again. T-reflex will be recorded during WBV.

A light (2.9 gr.) triaxial (x, y and z-axis) accelerometer (LIS344ALH, ECOPACK®) will be taped on the right Achilles tendon so that the z-axis will be perpendicular with the direction of the tendon (Achilles accelerometer). A custom-made reflex hammer will be used to tap the right Achilles tendon just caudal to the accelerometer. The intensity of tapping will be about 19.6 N WBV frequencies of 35 Hz will be delivered for 60 s. The vibration plate of WBV device (Power-Plate®Pro5, PowerPlate® International, Ltd. London, UK) oscillates with a linear movement upward and downward. The participants will be barefooted and stand directly on the vibration platform. The surface electromyography (SEMG) data will be obtained while the participants stand upright on the vibration platform with the knees in extension. The Ag/AgCl electrodes (KENDALL®Covidien) with a disc radius of 10 mm will be placed 20 mm apart on the right soleus muscle belly on shaved skin in accordance with the recommendations of the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) project .

The recordings of both T-reflex and WBV-IMR will be acquired using SEMG. SEMG data will be recorded using a PowerLAB® data acquisition system (ADInstruments, Oxford, United Kingdom) and the data will be analyzed offline using the LabChart7® (ver 7.3.7, ADInstruments, Oxford, United Kingdom) software.

Precautions for voluntary muscle contractions and motion artifacts:

  1. the participants will be asked to use the handles of the WBV device to secure their balance. The sense of balance may impair during WBV. Therefore muscles may be activated to restore balance during WBV,
  2. before WBV trials, participants will be asked to relax and not to make voluntary contractions in their lower extremity muscles.
  3. a trial protocol will be applied to familiarize vibration,
  4. all cables will be carefully taped to the skin to minimize motion artifacts,
  5. all EMG recordings will be filtered to avoid WBV induced movement artifacts using a band pass filter from 60 to 500 Hz.
02

Conditions studied

  • Effects of Vibration

Keywords

  • Whole body vibration
  • Bone myoregulation reflex
  • H-reflex
03

In context

Lead sponsor

Bagcilar Training and Research Hospital is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male
  • Right-handed men

Exclusion criteria

Exclusion Criteria:

  • Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and spine
  • Medication that could affect the musculoskeletal system
  • Postural abnormalities (scoliosis, kyphosis, etc)
  • Systemic diseases
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    WBV group

    whole-body vibration (WBV) group

    Other: vibration

Interventions

  • Othervibration

    Whole body vibration at 25Hz frequency

    Also known as: Whole body vibration

06

What researchers measure

Primary outcomes

  1. Presynaptic Ia inhibition level

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03016286
Lead sponsor
Bagcilar Training and Research Hospital
Responsible party
Ilhan Karacan, Clinical Associated Professor (Head of PMR clinic, Bagcilar Training and Research Hospital) — Principal investigator
First posted
Jan 10, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Apr 17, 2018 (estimated)
Completion
Apr 17, 2018 (estimated)
Last update
Jul 13, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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