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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03424551
Other study ID # IstPMRTRH-BMR1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 23, 2018
Est. completion date March 23, 2018

Study information

Verified date August 2019
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to estimate tonic vibration latency and whole body vibration reflex latency


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 23, 2018
Est. primary completion date February 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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

1. Lower extremity fracture

2. Lower extremity peripheral nerve lesions

3. 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 Design


Related Conditions & MeSH terms


Intervention

Device:
vibrator
Local or whole body vibration was applied at six different frequencies

Locations

Country Name City State
Turkey Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Türker 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. — View Citation

Cidem M, Karacan I, Diraçoglu D, Yildiz A, Küçük SH, Uludag M, Gün 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. — View Citation

Karacan I, Cidem M, Cidem M, Türker 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. — View Citation

Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Türker 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. — View Citation

Karamehmetoglu SS, Karacan I, Cidem M, Küçük SH, Ekmekçi H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Presynaptic inhibition level Change in Hmax amplitude during vibration 1 day
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