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CompletedNCT03424551VIRR&TVRUpdated Aug 20, 2019

Vibration Induced Reflex Responses and Estimation of TVR

An interventional study of vibrator in Muscle and Physiology, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Muscle
  • Physiology

Keywords

  • vibration
  • muscle spindle
  • H reflex
  • tonic vibration reflex
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

    Device: vibrator

Interventions

  • Devicevibrator

    Local or whole body vibration was applied at six different frequencies

    Also known as: cyclic mechanical loading

05

What researchers measure

Primary outcomes

  1. Presynaptic inhibition level

    Change in Hmax amplitude during vibration

    Time frame: 1 day

06

Study locations

1 site
  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    Istanbul, Turkey
07

References and documents

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. PubMed 4375172 ↗
  • 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. PubMed 24986541 ↗
  • 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 28457998 ↗
  • 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. PubMed 27485766 ↗
  • 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. PubMed 26310784 ↗
  • 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. PubMed 25551934 ↗
  • 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. PubMed 25207162 ↗
  • 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. PubMed 25198227 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03424551
Lead sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Jan 23, 2018
Primary completion
Feb 23, 2018
Completion
Mar 23, 2018
Last update
Aug 20, 2019

Study contacts

Mustafa A Yıldırım, MD
principal investigator · Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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