NCT03424551

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

1 month

First QC Date

January 24, 2018

Last Update Submit

August 18, 2019

Conditions

MusclePhysiology

Keywords

vibrationmuscle spindleH reflextonic vibration reflex

Outcome Measures

Primary Outcomes (1)

  • Presynaptic inhibition level

    Change in Hmax amplitude during vibration

    1 day

Study Arms (1)

Vibrator

EXPERIMENTAL

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

vibratorDEVICE

Local or whole body vibration was applied at six different frequencies

Also known as: cyclic mechanical loading
Vibrator

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Spastic spinal cord lesion
  • Patients between the ages of 20 and 45

You may not qualify if:

  • 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)
  • Ages 20 and 45 old years
  • Both sex
  • Healthy volunteers
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 4375172BACKGROUND

  • 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.

    PMID: 24986541BACKGROUND

  • 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.

    PMID: 28457998BACKGROUND

  • 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.

    PMID: 27485766BACKGROUND

  • 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.

    PMID: 26310784BACKGROUND

  • 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.

    PMID: 25551934BACKGROUND

  • 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.

    PMID: 25207162BACKGROUND

  • 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.

    PMID: 25198227BACKGROUND

Study Officials

  • Mustafa A Yıldırım, MD

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 7, 2018

Study Start

January 23, 2018

Primary Completion

February 23, 2018

Study Completion

March 23, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)