Reliability of Methods for Determining the Vibration Threshold (IPMTRH)
Primary Purpose
Reflex, Abnormal
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
whole body vibration
Sponsored by
About this trial
This is an interventional basic science trial for Reflex, Abnormal focused on measuring sensor, vibration, reflex
Eligibility Criteria
Inclusion Criteria:
- Both gender
- 20-40 aged
- Healthy volunteer
Exclusion Criteria:
- People with any health problems
Sites / Locations
- Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
The reflex response will be recorded during whole-body vibration.
Outcomes
Primary Outcome Measures
Threshold vibration stimulus
Threshold vibration stimulus intensity that activates the reflex response
Secondary Outcome Measures
Full Information
NCT ID
NCT05129982
First Posted
November 8, 2021
Last Updated
December 13, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05129982
Brief Title
Reliability of Methods for Determining the Vibration Threshold
Acronym
IPMTRH
Official Title
Reliability of Methods for Determining the Vibration Threshold That Triggers the Reflex
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflex, Abnormal
Keywords
sensor, vibration, reflex
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
self-controlled study
Masking
None (Open Label)
Masking Description
With the cumulative average method, latency estimation will be made blindly.
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The reflex response will be recorded during whole-body vibration.
Intervention Type
Device
Intervention Name(s)
whole body vibration
Intervention Description
whole body vibration is a modality of physical therapy
Primary Outcome Measure Information:
Title
Threshold vibration stimulus
Description
Threshold vibration stimulus intensity that activates the reflex response
Time Frame
A single point in time (1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Both gender
20-40 aged
Healthy volunteer
Exclusion Criteria:
People with any health problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İLHAN KARACAN
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
City
Istanbul
ZIP/Postal Code
34173
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Learn more about this trial
Reliability of Methods for Determining the Vibration Threshold
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