Vibration Induced Reflex Responses and Estimation of TVR (VIRR&TVR)

Vibration-induced Reflex Responses and Estimation of Tonic Vibration Latency

The aim of this study is to estimate tonic vibration latency and whole body vibration reflex latency

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was included 17 patients with spastic spinal cord lesions and 23 healthy control.

Soleus T-reflex, soleus H-reflex, soleus tonic vibration reflex (TVR), and reflex muscle response induced by whole body vibration was evaluated this study. To obtain the H-reflex response, the tibial nerve in the popliteal region was stimulated by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records was taken with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on skin according to the SENIAM protocol. To obtain T-reflex response, an electronic reflex hammer (Elcon 100-150 Germany) was used. After H-reflex and T reflex records at rest, to obtain Tonic vibration reflex, local vibration was applied to the Achilles tendon at 50, 85, 140, 185, 235 and 265 Hz. To obtain the reflex response induced by Whole body vibration, vibration was applied at 35, 37, 39, 41, 43 and 45 Hz. Tibial nerve stimulation was performed again to determine Hmax during whole body vibration and local vibration.H-reflex records was taken while the subject is sitting on a chair.

The data was recorded with the PowerLab data acquisition device (ADInstrument Oxford UK). For Whole-body vibration, PowerPlate Pro5 (London UK) was used.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

All

Description

Inclusion Criteria spinal cord injury patients:

  • Spastic spinal cord lesion
  • Patients between the ages of 20 and 45

Exclusion Criteria for spinal cord injury patients

  • Accompanying trauma

    1. Lower extremity fracture
    2. Lower extremity peripheral nerve lesions
    3. Head trauma
  • Autonomic dysreflexia
  • Heterotopic ossification
  • Lesions in calf skin
  • Excessive spasticity (Ashwort4) / Contracture (knee, hip, footbath)
  • Peripheral nerve-vascular diseases / muscle diseases
  • Pressure ulcer (> Grade 2)

Inclusion criteria for Control

  • Ages 20 and 45 old years
  • Both sex
  • Healthy volunteers

Exclusion Criteria for Control

  • Pregnant women

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Vibrator
Local or Whole body vibration was applied at six different frequencies to Healthy control and spastic spinal cord injury. For local vibration, vibration frequencies were 50, 85, 140, 185, 235 and 265 Hz . For whole body vibration, vibration frequencies were 35, 37, 39, 41, 43 and 45 Hz
Local or whole body vibration was applied at six different frequencies
Other Names:
  • cyclic mechanical loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presynaptic inhibition level
Time Frame: 1 day
Change in Hmax amplitude during vibration
1 day

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Mustafa A Yıldırım, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

January 23, 2018

Primary Completion (ACTUAL)

February 23, 2018

Study Completion (ACTUAL)

March 23, 2018

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (ACTUAL)

February 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 18, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IstPMRTRH-BMR1

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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