- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424551
Vibration Induced Reflex Responses and Estimation of TVR (VIRR&TVR)
Vibration-induced Reflex Responses and Estimation of Tonic Vibration Latency
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
- Lower extremity fracture
- Lower extremity peripheral nerve lesions
- 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
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 |
|---|---|
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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
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Local or whole body vibration was applied at six different frequencies
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Presynaptic inhibition level
Time Frame: 1 day
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Change in Hmax amplitude during vibration
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1 day
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Collaborators and Investigators
Investigators
- Principal Investigator: Mustafa A Yıldırım, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publications and helpful links
General Publications
- Ashby P, Verrier M, Lightfoot E. Segmental reflex pathways in spinal shock and spinal spasticity in man. J Neurol Neurosurg Psychiatry. 1974 Dec;37(12):1352-60. doi: 10.1136/jnnp.37.12.1352.
- Alizadeh-Meghrazi M, Masani K, Zariffa J, Sayenko DG, Popovic MR, Craven BC. Effect of whole-body vibration on lower-limb EMG activity in subjects with and without spinal cord injury. J Spinal Cord Med. 2014 Sep;37(5):525-36. doi: 10.1179/2045772314Y.0000000242. Epub 2014 Jul 1.
- 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.
- Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.
- 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.
- Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.
- Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
- Cakar HI, Cidem M, Kara S, Karacan I. Vibration paradox and H-reflex suppression: is H-reflex suppression results from distorting effect of vibration? J Musculoskelet Neuronal Interact. 2014 Sep;14(3):318-24.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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