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Determination of Onset Point of Mechanical Stimulation (TrueRL)

Primary Purpose

Reflex, Abnormal

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Electrodiagnostic test
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Reflex, Abnormal

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Both gender
  • 20-45 aged
  • Healthy volunteer

Exclusion Criteria:

  • People with any health problems

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiment

Arm Description

Reflex latency will be measured in this arm

Outcomes

Primary Outcome Measures

muscle spindle- based reflex latency
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".

Secondary Outcome Measures

Full Information

First Posted
April 12, 2020
Last Updated
August 30, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04347083
Brief Title
Determination of Onset Point of Mechanical Stimulation
Acronym
TrueRL
Official Title
A New Method to Determine Onset Point of Mechanical Stimulation Inducing Muscle Spindle-Based Stretch Reflex by Using Intramuscular Electromyography Electrodes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 13, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflex, Abnormal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
Reflex latency will be measured in this arm
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrodiagnostic test
Intervention Description
Muscle spindle- based reflex latency will be measured
Primary Outcome Measure Information:
Title
muscle spindle- based reflex latency
Description
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".
Time Frame
1 day (a single point in time)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Both gender 20-45 aged Healthy volunteer Exclusion Criteria: People with any health problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilhan Karacan, Assoc Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
İstanbul
ZIP/Postal Code
34192
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28457998
Citation
Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.
Results Reference
result
PubMed Identifier
31942042
Citation
Yildirim MA, Topkara B, Aydin T, Paker N, Soy D, Coskun E, Ones K, Bardak A, Kesiktas N, Ozyurt MG, Celik B, Onder B, Kilic A, Kucuk HC, Karacan I, Turker KS. Exploring the receptor origin of vibration-induced reflexes. Spinal Cord. 2020 Jun;58(6):716-723. doi: 10.1038/s41393-020-0419-5. Epub 2020 Jan 15.
Results Reference
result
PubMed Identifier
32024411
Citation
Aydin T, Kesiktas FN, Baskent A, Karan A, Karacan I, Turker KS. Cross-training effect of chronic whole-body vibration exercise: a randomized controlled study. Somatosens Mot Res. 2020 Jun;37(2):51-58. doi: 10.1080/08990220.2020.1720635. Epub 2020 Feb 5.
Results Reference
result
PubMed Identifier
26310784
Citation
Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Turker KS. Whole-body vibration-induced muscular reflex: Is it a stretch-induced reflex? J Phys Ther Sci. 2015 Jul;27(7):2279-84. doi: 10.1589/jpts.27.2279. Epub 2015 Jul 22.
Results Reference
result
PubMed Identifier
25100978
Citation
Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
Results Reference
result

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Determination of Onset Point of Mechanical Stimulation

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