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Bone Myoregulation Reflex & Presynaptic Ia Inhibition

This study is not yet open for participant recruitment.
Verified July 2017 by Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03016286
First Posted: January 10, 2017
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
  Purpose

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.


Condition Intervention
Effects of Vibration Other: vibration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Cooling of Ankle on Bone Myoregulation Reflex Response and Presynaptic Ia Inhibition Level

Further study details as provided by Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Presynaptic Ia inhibition level [ Time Frame: 1 month ]

Estimated Enrollment: 10
Anticipated Study Start Date: November 1, 2017
Estimated Study Completion Date: April 17, 2018
Estimated Primary Completion Date: April 17, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WBV group
whole-body vibration (WBV) group
Other: vibration
Whole body vibration at 25Hz frequency
Other Name: Whole body vibration

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Ilhan Karacan, Clinical Associated Professor, Head of PMR clinic, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03016286     History of Changes
Other Study ID Numbers: BMR20171
First Submitted: January 8, 2017
First Posted: January 10, 2017
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital:
Whole body vibration
Bone myoregulation reflex
H-reflex