Determination of Onset Point of Mechanical Stimulation (TrueRL)

August 30, 2021 updated by: Ilhan KARACAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

A New Method to Determine Onset Point of Mechanical Stimulation Inducing Muscle Spindle-Based Stretch Reflex by Using Intramuscular Electromyography Electrodes

The difference between latencies of the tonic vibration reflex or T-reflex and whole body vibration-induced muscular reflex may be related to the distance between their stimulation point and the muscle spindles. Achilles tendon is mechanically stimulated by using a local vibrator to elicit the tonic vibration reflex or a reflex hammer to elicit the T-reflex. Whole body vibration, however, stimulates the soleus muscle indirectly over the heel, not directly, since whole body vibration is administered in a position that the subjects are standing on the whole body vibration platform. In other words, while the local vibrator or the hammer stimulates the Achilles tendon, whole body vibration stimulates the sole of the foot. During whole body vibration, mechanical vibration stimuli need to go a long way to reach the soleus muscle spindle. Therefore, whole body vibration-induced muscular reflex latency may be longer than tonic vibration reflex or T-reflex latency. The aim this study is to define a method for determination of onset point of mechanical stimulation inducing muscle spindle-based reflex (e.g., tonic vibration reflex, T-reflex) by using intramuscular electromyography electrodes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to define a method for the determination of the onset point of mechanical stimulation inducing muscle spindle-based reflex by using Intramuscular electromyography electrodes. This research protocol has two phases: First, the method of measuring latency using MAS was described in Experiment-I. The validity of this method was then determined in Experiment II. Eight healthy volunteers will participate in experiment-I and five healthy volunteers will participate in experiment II. Two surface electromyography electrodes will be placed on the left gastrocnemius muscle belly to record spindle-based reflex response. Single motor unit electrode pairs will be then inserted between two surface electrodes into the lateral gastrocnemius muscle to record stimulus artifact caused by tapping. The Achilles tendon will be tapped 20 times at 3-5 s intervals by a reflex hammer (Achilles tapping). Participants will be then asked to stand up and stand upright on the left foot. To maintain static balance, participants will be asked to hold the handles on the wall. The left heel will be tapped 20 times at 3-5 s intervals by a hammer (Heel tapping). In experiment II, the records from multiple sites gastrocnemius lateralis and rectus femoris) will be taken to characterize how movement artifacts change based on the location of the recording electrode. Using electric signals of the switch system as the trigger and the signals recorded by intramuscular electrodes and accelerometer as the source, spike-triggered averaging was used to determine the lag time it takes for the mechanical stimulus to reach the belly of the gastrocnemius and rectus femoris muscles. Meanwhile, the internal delay time of the accelerometers (the time between the mechanical stimulus moment and the signal output moment from the accelerometer) was determined. Using electric signals of the switch system as the trigger and the signals of accelerometers as the source, spike-triggered averaging was used to determine the internal delay time of accelerometers.

Study Type

Interventional

Enrollment (Actual)

13

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

  • Turkey
      • İstanbul, Turkey, 34192
        • 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:

  • Both gender
  • 20-45 aged
  • Healthy volunteer

Exclusion Criteria:

  • People with any health problems

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: Experiment
Reflex latency will be measured in this arm
Diagnostic test: Electrodiagnostic test
Muscle spindle- based reflex latency will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle spindle- based reflex latency
Time Frame: 1 day (a single point in time)
Duration between the onset point of mechanical stimulation and onset point of muscle spindle- based reflex latency response is defined as "muscle spindle- based reflex latency".
1 day (a single point in time)

Collaborators and Investigators

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

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Ilhan Karacan, Assoc Prof, Istanbul Physical Medicine Rehabilitation Training & 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)

April 13, 2020

Primary Completion (Actual)

August 20, 2021

Study Completion (Actual)

August 20, 2021

Study Registration Dates

First Submitted

April 12, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISTPMR

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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