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VIRR&TVR: Vibration Induced Reflex Responses and Estimation of TVR

Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03424551
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
1.9
Actual Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: vibrator
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Vibration-induced Reflex Responses and Estimation of Tonic Vibration Latency
Actual Study Start Date :
Jan 23, 2018
Actual Primary Completion Date :
Feb 23, 2018
Actual Study Completion Date :
Mar 23, 2018

Arms and Interventions

Arm Intervention/Treatment
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
Local or whole body vibration was applied at six different frequencies
Other Names:
  • cyclic mechanical loading

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presynaptic inhibition level [1 day]

      Change in Hmax amplitude during vibration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Investigators

    • Principal Investigator: Mustafa A Yıldırım, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT03424551
    Other Study ID Numbers:
    • IstPMRTRH-BMR1
    First Posted:
    Feb 7, 2018
    Last Update Posted:
    Aug 20, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital
    vibration
    muscle spindle
    H reflex
    tonic vibration reflex

    Study Results

    No Results Posted as of Aug 20, 2019