Bone Myoregulation Reflex & Presynaptic Ia Inhibition

July 11, 2017 updated by: Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital

Effects of Cooling of Ankle on Bone Myoregulation Reflex Response and Presynaptic Ia Inhibition Level

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.

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male
  • Right-handed men

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: WBV group
whole-body vibration (WBV) group
Whole body vibration at 25Hz frequency
Other Names:
  • Whole body vibration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presynaptic Ia inhibition level
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

April 17, 2018

Study Completion (Anticipated)

April 17, 2018

Study Registration Dates

First Submitted

January 8, 2017

First Submitted That Met QC Criteria

January 8, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BMR20171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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