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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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