Reflex, AbnormalTrueRLNCT04347083
Determination of Onset Point of Mechanical Stimulation
A study testing Electrodiagnostic test in people with Reflex, Abnormal, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Reflex, Abnormal
- What is being tested?
- Electrodiagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2020to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both gender
- 20-45 aged
- Healthy volunteer
Who cannot join
- People with any health problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, 34192
About this study
Official title: 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.
Read the 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.
- Conditions
- Reflex, Abnormal
- Being tested
- Electrodiagnostic test
- Medical subject headings
- Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrodiagnostic testDiagnostic test
Muscle spindle- based reflex latency will be measured
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Reflex latency will be measured in this arm Receives: Diagnostic Test: Electrodiagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 1 day (a single point in time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start13 Apr 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Reflex, AbnormalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan KARACAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Ilhan Karacan, Assoc Prof, Principal investigator, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347083
- Sponsor's protocol ID
- ISTPMR
- Acronym
- TrueRL
- Status last verified
- Aug 2021
- First submitted
- 12 Apr 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28457998Yildirim 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.
PubMed 31942042Aydin 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.
PubMed 32024411Cakar 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.
PubMed 26310784Karacan 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.
PubMed 25100978
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Method to Determine Onset Point of Mechanical Stimulation Inducing Muscle Spindle-Based Stretch Reflex by Using Intramuscular Electromyography Electrodes
- ClinicalTrials.gov ID
- NCT04347083
- Acronym / sponsor ID
- TrueRL / ISTPMR
- Conditions
- Reflex, Abnormal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Diagnostic Test: Electrodiagnostic testReflex latency will be measured in this arm |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both gender
- 20-45 aged
- Healthy volunteer
Key exclusion criteria (1 listed)
- People with any health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrodiagnostic testMuscle spindle- based reflex latency will be measured | Diagnostic test | Experiment |
Primary outcome
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Results publication: PubMed 28457998Karacan 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 publication: PubMed 31942042Yildirim 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 publication: PubMed 32024411Aydin 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 publication: PubMed 26310784Cakar 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 publication: PubMed 25100978Karacan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilhan Karacan, Assoc Prof principal investigator
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrodiagnostic test in people with Reflex, Abnormal, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle spindle- based reflex latency (time frame: 1 day (a single point in time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347083, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.