Reflex, AbnormalIPMTRHNCT05129982
Reliability of Methods for Determining the Vibration Threshold
A study testing whole body vibration in people with Reflex, Abnormal, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reflex, Abnormal
- What is being tested?
- whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2021to 13 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both gender
- 20-40 aged
- Healthy volunteer
Who cannot join
- People with any health problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
About this study
Official title: Reliability of Methods for Determining the Vibration Threshold That Triggers the Reflex
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".
- Conditions
- Reflex, Abnormal
- Being tested
- whole body vibration
- Keywords
- sensor, vibration, reflex
- Medical subject headings
- Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationDevice
whole body vibration is a modality of physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The reflex response will be recorded during whole-body vibration. Receives: Device: whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold vibration stimulus
Threshold vibration stimulus intensity that activates the reflex response
Measured: A single point in time (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start9 Dec 2021
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflex, AbnormalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- self-controlled study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- İLHAN KARACAN, Principal investigator, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129982
- Sponsor's protocol ID
- WBVsensor
- Acronym
- IPMTRH
- Status last verified
- Dec 2021
- First submitted
- 8 Nov 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Methods for Determining the Vibration Threshold That Triggers the Reflex
- ClinicalTrials.gov ID
- NCT05129982
- Acronym / sponsor ID
- IPMTRH / WBVsensor
- Conditions
- Reflex, Abnormal
- Keywords
- sensor, vibration, reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- self-controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: whole body vibrationThe reflex response will be recorded during whole-body vibration. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both gender
- 20-40 aged
- Healthy volunteer
Key exclusion criteria (1 listed)
- People with any health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibrationwhole body vibration is a modality of physical therapy | Device | Intervention |
Primary outcome
Threshold vibration stimulus
Time frame: A single point in time (1 day)
Threshold vibration stimulus intensity that activates the reflex response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İLHAN KARACAN principal investigator
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration in people with Reflex, Abnormal, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold vibration stimulus (time frame: A single point in time (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.