ClinicalTrials.gg
CompletedNCT05129982IPMTRHUpdated Jan 3, 2022

Reliability of Methods for Determining the Vibration Threshold

An interventional study of whole body vibration in Reflex, Abnormal, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-03.

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

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study summary

It is known that whole-body vibration (TVV) has beneficial neuromuscular effects such as muscle strength increase. These beneficial effects are explained by the muscular reflex response induced by TVV. Reflex latency measurement is frequently used in clinical and neurophysiological research. The latency of the reflex response induced by TVV is defined as the period between the onset of the vibration stimulus and the onset point of the spike in the EMG signal. The current research aimed to determine whether the cumulative average method is reliable for estimating the EST.

Read the detailed description

This is an experimental study for method development; a self-controlled (single group) study. Ten healthy male or female subjects between the ages of 18-45 will be included in the study. After obtaining informed consent from the subjects, 30 Hz low amplitude (2 mm) vibration for 30 seconds will be applied on the PowerPlate Pro5 device to meet TVV. After three minutes of rest, two sets of TVV will be applied for test purposes. For the test TVV, vibration will be applied at 25, 30, 35, 40, 45, 50 Hz frequencies, each lasting 30 seconds, with low amplitude.

Vibration stimuli detected by using an accelerometer fixed on the TVV platform will be recorded the Data acquisition (PowerLab data acquisition system (ADInstruments, Oxford, United Kingdom). Soleus EMG responses will be recorded using the superficial electrodes (Kendall Covidien). The sample rate for recordings will be 40KHz.

Latency calculation with Cumulative Average Method: It will be done. An 80-500 Hz band-pass filter and full-wave rectification will be applied to EMG recordings. The peak of reflex responses (spike) will be marked with the help of LabChart7 (ver 7.3.7, ADInstruments, Oxford, United Kingdom). According to this marked point, the averaging process covered 75 ms of the vibration data preceding the trigger and 15 ms after for each vibration frequency separately. Then, the average of the five vibration frequencies will be calculated for the accelerometer recordings and EMG recordings. The point where the standard error is lowest in the accelerometer recordings will be determined as the "effective stimulation point".

02

Conditions studied

  • Reflex, Abnormal

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Keywords

  • sensor
  • vibration
  • reflex
03

In context

Reflex, Abnormal

18 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.

This study's enrollment of 11 is below the median of 16 across 13 interventional studies indexed under Reflex, Abnormal.

Browse Reflex, Abnormal studies →

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Both gender
  • 20-40 aged
  • Healthy volunteer

Exclusion criteria

Exclusion Criteria:

  • People with any health problems
05

Study design

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

Study arms

  • Experimental
    Intervention

    The reflex response will be recorded during whole-body vibration.

    Device: whole body vibration

Interventions

  • Devicewhole body vibration

    whole body vibration is a modality of physical therapy

06

What researchers measure

Primary outcomes

  1. Threshold vibration stimulus

    Threshold vibration stimulus intensity that activates the reflex response

    Time frame: A single point in time (1 day)

07

Study locations

1 site
  • Istanbul Physical Medicine Rehabilitation Training & Research Hospital
    Istanbul, 34173, Turkey
08

References and documents

Individual participant data

Plan to share: No — The data that support the findings of this study are available from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2021 to primary completion in Dec 2021, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2021
First posted
Nov 22, 2021
StartActual
Dec 9, 2021
Primary completionActual
Dec 13, 2021
CompletionActual
Dec 13, 2021
Last update
Jan 3, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05129982
Responsible party
Sponsor
First posted
Nov 22, 2021
Start date
Dec 9, 2021
Primary completion
Dec 13, 2021
Completion
Dec 13, 2021
Last update
Jan 3, 2022

Study contacts

İLHAN KARACAN
principal investigator · Istanbul Physical Medicine Rehabilitation Training & 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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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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