Latency Period (Psychology)NCT01908439
A Simple Method to Determine the Reflex Latency During WBV
A study testing whole-body vibration in people with Latency Period (Psychology), run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to examine the validity of the measurement method based on observation of vibration stimulation-MUAP (motor unit action potential) (1 to 1) matching that helps to measure human WBV-induced muscular reflex latency and to compare these results with the latency determination obtained using… Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Latency Period (Psychology)
- What is being tested?
- whole-body vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Aug 2013
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adult (20-45 yrs)
- Healthy
- Right handed
Who cannot join
- Any health problems
- Left handed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bağcılar Training & Research Hospital
Istanbul
About this study
Official title: A Simple Method to Determine the Reflex Latency During Whole Body Vibration
The purpose of this study was to examine the validity of the measurement method based on observation of vibration stimulation-MUAP (motor unit action potential) (1 to 1) matching that helps to measure human WBV-induced muscular reflex latency and to compare these results with the latency determination obtained using the classical methods. The investigators' principle hypothesis is that the simple method is capable of determining the WBV induced reflex response latency as reliably as the complex methods described earlier.
To achieve this goal, the investigators have averaged the electrical responses of the soleus muscle (sEMG and multi motor unit (MMU) potential) against the vertical force data obtained during all the six vibration frequencies tested in this study. The investigators have then combined all the averaged EMG data belonging to six different vibration frequencies to generate the 'cumulative averaged' sEMG and MMU for each subject. The investigators have also obtained the standard error for the cumulative averaged records which indicated the WBV-induced muscular reflex (WBV-IMR) latency.
Read the detailed description
Subjects Five healthy volunteers will be participated in the study.
Procedures During WBV, the subjects will be asked to stand upright on a vibration platform (PowerPlate Pro5, London, United Kingdom). Their hips and knees will be in a neutral position. Subjects will be barefooted, and no sponge or foam will be placed between the vibration platform and their feet (Figure 1). The whole plate oscillates with a linear movement upward and downward. Vibration amplitude is 2.2 mm. WBV frequencies will be varied randomly to cover the following six frequencies: 25, 30, 35, 40,45 and 50 Hz. Each frequency lasts for 60 seconds and there will be a 15 seconds rest in between different frequencies.
A load sensor (FC2331-0000-2000L Compression Load Sensor, France) will be fixed on the WBV platform in order to be able to determine induced muscular response latency. Subjects will be positioned on the WBV platform such that their right heel will be placed on the load sensor.
Recordings MMUs, surface EMG (sEMG) and force recordings will be simultaneously done using the Powerlab data acquisition system (ADInstruments, Oxford, United Kingdom). A sampling frequency of 40 kiloHertz (kHz) will be used. Data will be analyzed offline using the MATLAB (R2012a 7.14.0.739).
In order to record sEMG, Ag/AgCl electrodes [KENDALL ® Arbo] with a disc radius of 10 mm will be placed 20 mm apart on the right soleus muscle belly, on shaved skin cleaned with alcohol. The ground electrode will be placed on the lateral malleolus.
To record MMU activity, a pair of Teflon® insulated silver wires (75 µm in core diameter) will be used. About 3 mm of the tips of the silver wires will be stripped of their Teflon ® coating in order to be able to record the activity of several motor units. The pair of wires will be inserted into the right soleus muscle with a 25 G needle. Needle will be immediately withdrawn leaving the fish-hooked wires in the muscle. A lip-clip electrode will be used as the ground electrode.
All cables will be carefully taped to the skin to minimize mechanical artifacts.
The subjects will be instructed to relax their muscles throughout the recordings and were trained using EMG feedback to this end. WBV may impair the sense of balance and muscles may be activated to restore balance. To overcome this issue, the subjects will be familiarized with WBV with a 15 s session of WBV, the subjects will be asked to use the handles of the WBV device to secure their balance and the base of support (distance between the heels) will be adjusted as wide. The distance between the heels usually will be about 25 cm.
Filtering and Rectification regimens All force sensor recordings will be 5 Hz high-pass filtered. All sEMG recordings will be 80 - 500 Hz band-pass filtered (Butterworth 1st order) and full-wave rectified to overcome movement artifacts. All MMU recordings will be 100-5000 Hz band-pass filtered (Butterworth 1st order) and full-wave rectified.
WBV - induced muscular reflex (WBV-IMR) latency
In a previous study, right soleus muscle sEMG measurement and force sensor measurement that is placed under right heel during WBV were taken synchronously and it was found that vibration stimulation and MUAPs would be matched 1 to 1. In this study that is based on the previous observation, it is predicted that it is possible to calculate latency by using averaging method.
All MMU and sEMG data will be analyzed by applying respectively filtering, rectification and differentiation with MATLAB (R2012a 7.14.0.739). Data analysis will be performed in two stages:
- Detection of the moment of mechanical stimulation threshold (Force Sensor Data Averaging): Force sensor data will be averaged by using Spike triggered averaging (STA) method. For this, 50 seconds of constant time intervals of preset vibration frequency in a WBV set will be used. All the positive peaks in both MMU and sEMG traces will be marked. For all the positive peaks, the force sensor trace will be segmented covering 75 ms previous positive peak. After, cumulative average of these 6 vibration sets will be averaged. The standard error on the cumulative averaged force records will be calculated. The lowest point of standard error on force sensor averaging graphic will be considered as the starting point of mechanical stimulation that triggers the muscle response.
- Determination of the MUAP onset: EMG data averaging method and manual method (vibration stimulus and MUAP coupling) will be used.
- Conditions
- Latency Period (Psychology)
- Being tested
- whole-body vibration
- Keywords
- muscle electrical activity, whole-body vibration, latency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibrationOther
Also called Cyclic mechanical loading
High amplitude whole-body vibration
| Study group | Role | What they receive |
|---|---|---|
| Whole-body vibration | Experimental | A new method for muscle reflex latency measurement Receives: Other: whole-body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency measurement method
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latency Period (Psychology)Studies 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- İlhan Karacan, MD, Study chair, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908439
- Sponsor's protocol ID
- BEAH FTR-9
- Status last verified
- Sep 2013
- First submitted
- 18 Jul 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Method to Determine the Reflex Latency During Whole Body Vibration
- ClinicalTrials.gov ID
- NCT01908439
- Acronym / sponsor ID
- BEAH FTR-9
- Conditions
- Latency Period (Psychology)
- Keywords
- muscle electrical activity, whole-body vibration, latency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
The purpose of this study was to examine the validity of the measurement method based on observation of vibration stimulation-MUAP (motor unit action potential) (1 to 1) matching that helps to measure human WBV-induced muscular reflex latency and to compare these results with the latency determination obtained using the classical methods. The investigators' principle hypothesis is that the simple method is capable of determining the WBV induced reflex response latency as reliably as the complex methods described earlier.
To achieve this goal, the investigators have averaged the electrical responses of the soleus muscle (sEMG and multi motor unit (MMU) potential) against the vertical force data obtained during all the six vibration frequencies tested in this study. The investigators have then combined all the averaged EMG data belonging to six different vibration frequencies to generate the 'cumulative averaged' sEMG and MMU for each subject. The investigators have also obtained the standard error for the cumulative averaged records which indicated the WBV-induced muscular reflex (WBV-IMR) latency.
Detailed description
Subjects Five healthy volunteers will be participated in the study.
Procedures During WBV, the subjects will be asked to stand upright on a vibration platform (PowerPlate Pro5, London, United Kingdom). Their hips and knees will be in a neutral position. Subjects will be barefooted, and no sponge or foam will be placed between the vibration platform and their feet (Figure 1). The whole plate oscillates with a linear movement upward and downward. Vibration amplitude is 2.2 mm. WBV frequencies will be varied randomly to cover the following six frequencies: 25, 30, 35, 40,45 and 50 Hz. Each frequency lasts for 60 seconds and there will be a 15 seconds rest in between different frequencies.
A load sensor (FC2331-0000-2000L Compression Load Sensor, France) will be fixed on the WBV platform in order to be able to determine induced muscular response latency. Subjects will be positioned on the WBV platform such that their right heel will be placed on the load sensor.
Recordings MMUs, surface EMG (sEMG) and force recordings will be simultaneously done using the Powerlab data acquisition system (ADInstruments, Oxford, United Kingdom). A sampling frequency of 40 kiloHertz (kHz) will be used. Data will be analyzed offline using the MATLAB (R2012a 7.14.0.739).
In order to record sEMG, Ag/AgCl electrodes [KENDALL ® Arbo] with a disc radius of 10 mm will be placed 20 mm apart on the right soleus muscle belly, on shaved skin cleaned with alcohol. The ground electrode will be placed on the lateral malleolus.
To record MMU activity, a pair of Teflon® insulated silver wires (75 µm in core diameter) will be used. About 3 mm of the tips of the silver wires will be stripped of their Teflon ® coating in order to be able to record the activity of several motor units. The pair of wires will be inserted into the right soleus muscle with a 25 G needle. Needle will be immediately withdrawn leaving the fish-hooked wires in the muscle. A lip-clip electrode will be used as the ground electrode.
All cables will be carefully taped to the skin to minimize mechanical artifacts.
The subjects will be instructed to relax their muscles throughout the recordings and were trained using EMG feedback to this end. WBV may impair the sense of balance and muscles may be activated to restore balance. To overcome this issue, the subjects will be familiarized with WBV with a 15 s session of WBV, the subjects will be asked to use the handles of the WBV device to secure their balance and the base of support (distance between the heels) will be adjusted as wide. The distance between the heels usually will be about 25 cm.
Filtering and Rectification regimens All force sensor recordings will be 5 Hz high-pass filtered. All sEMG recordings will be 80 - 500 Hz band-pass filtered (Butterworth 1st order) and full-wave rectified to overcome movement artifacts. All MMU recordings will be 100-5000 Hz band-pass filtered (Butterworth 1st order) and full-wave rectified.
WBV - induced muscular reflex (WBV-IMR) latency
In a previous study, right soleus muscle sEMG measurement and force sensor measurement that is placed under right heel during WBV were taken synchronously and it was found that vibration stimulation and MUAPs would be matched 1 to 1. In this study that is based on the previous observation, it is predicted that it is possible to calculate latency by using averaging method.
All MMU and sEMG data will be analyzed by applying respectively filtering, rectification and differentiation with MATLAB (R2012a 7.14.0.739). Data analysis will be performed in two stages:
- Detection of the moment of mechanical stimulation threshold (Force Sensor Data Averaging): Force sensor data will be averaged by using Spike triggered averaging (STA) method. For this, 50 seconds of constant time intervals of preset vibration frequency in a WBV set will be used. All the positive peaks in both MMU and sEMG traces will be marked. For all the positive peaks, the force sensor trace will be segmented covering 75 ms previous positive peak. After, cumulative average of these 6 vibration sets will be averaged. The standard error on the cumulative averaged force records will be calculated. The lowest point of standard error on force sensor averaging graphic will be considered as the starting point of mechanical stimulation that triggers the muscle response.
- Determination of the MUAP onset: EMG data averaging method and manual method (vibration stimulus and MUAP coupling) will be used.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-body vibration | Experimental | Other: whole-body vibrationA new method for muscle reflex latency measurement |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Young adult (20-45 yrs)
- Healthy
- Right handed
Key exclusion criteria (2 listed)
- Any health problems
- Left handed
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 vibrationAlso: Cyclic mechanical loadingHigh amplitude whole-body vibration | Other | Whole-body vibration |
Primary outcome
Latency measurement method
Time frame: 1 day
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 4 Sep 2013.
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, MD study chair
Bagcilar 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 Latency Period (Psychology), run by Bagcilar 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 2 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 4 Sep 2013. 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?
Latency measurement method (time frame: 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 4 Sep 2013.