NCT01780376

Brief Summary

Whole Body Vibration (WBV) applies thrust force in opposite direction to gravity to body.This mechanical stimulation induces reflex muscular activity. Tonic vibration reflex (TVR) is most commonly cited mechanism to explain WBV-induced reflex muscular activity (WBV-IRMA), although there is no conclusive evidence that TVR occurs. The bone myoregulation reflex is another neurologic mechanism used to explain the effects of vibration on muscular performance. Investigators hypothesized that latency of WBV-IRMA is different from latency of TVR. Primary aim of this study is to determine latency of WBV-IRMA. Secondary aim is to investigate whether WBV-IRMA is explained with TVR. Twenty healthy young adult men are planned to include in this study. Participants will stand upright with their knees locked during WBV. PowerPlate Pro5 will be used for WBV. WBV with high amplitude at 25,30,35,40,45 and 50 Hz will be applied. Surface electrodes will be placed on both the soleus muscles. To measure TVR latency, piezo-electric accelerometer will be placed on the achilles tendon and this achilles tendon will be stimulated with spring based mechanical reflex hammer. Our pilot study was showed that motor unit potentials (MUAP) occurred in a 1:1 response with vibration. After confirmation of this finding, WBV-IRMA latency will be measured in the present study. To measure WBV-IRMA latency, piezo-electric force sensor will be placed between heel and WBV platform. Exact moment of initial strike of heel when thrust force expressed by WBV begin to be transferred to body will be determined. The time between moment of the initial strike and corresponding MUAP is defined as "WBV-IRMA latency". Piezo-electric stretch sensor will be placed between knee and malleol to simulate muscle spindle. The reflex muscle activity of soleus muscles will be measured by PowerLab (data acquisition system, ADInstruments, Australia) device. This project is planed to be completed in 1 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2013

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

Same day

First QC Date

January 28, 2013

Last Update Submit

June 18, 2015

Conditions

Keywords

whole-body vibrationlatencyreflex responsemuscle

Outcome Measures

Primary Outcomes (1)

  • latency of reflex muscle activity

    Whole-body vibration induced reflex muscle activity latency

    1 month

Study Arms (1)

WBV group

EXPERIMENTAL

whole-body vibration (WBV) group

Procedure: whole-body vibration (WBV)

Interventions

whole-body vibration (4 mm amplitude, 25,30,35,40,45,50 Hz)

Also known as: Cyclic mechanical loading
WBV group

Eligibility Criteria

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

You may qualify if:

  • Healthy men
  • Men with ages varying between 20 and 45 years
  • Right-handed men

You may not qualify if:

  • Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and spine
  • Medication that could affect the musculoskeletal system
  • Postural abnormalities (scoliosis, kyphosis, etc)
  • Systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar TRH

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • ILHAN KARACAN, MD

    Bagcilar Training & Research Hospital

    STUDY CHAIR
  • MUHARREM CIDEM, MD

    Bagcilar Training & Research Hospital

    PRINCIPAL INVESTIGATOR
  • HALIL I CAKAR, PhD

    Fatih University Biomedical Engineering Instıtute

    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 28, 2013

First Posted

January 31, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations