Effects of VibrationNCT03016286
Bone Myoregulation Reflex & Presynaptic Ia Inhibition
A study testing vibration in people with Effects of Vibration, run by Bagcilar Training and Research Hospital.
Trial summary
Hypotheses of this study are 1. Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body vibration (WBV) 2. Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this study is to test these hypotheses. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Vibration
- What is being tested?
- vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 17 Apr 2018
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male
- Right-handed men
Who cannot join
- 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
About this study
Official title: Effects of Cooling of Ankle on Bone Myoregulation Reflex Response and Presynaptic Ia Inhibition Level
Hypotheses of this study are
- Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body vibration (WBV)
- Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this study is to test these hypotheses.
Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at 35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20 minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of the right ankle, and during WBV respectively.
Read the detailed description
Hypotheses of this study are
- Bone myoregulation reflex (BMR) inhibits presynaptically T-reflex during whole-body vibration (WBV)
- Cooling of ankle abolishes the inhibitor effect of BMR on soleus T-reflex Aim of this study is to test these hypotheses.
Methods:
Participants:
Ten young, healthy and right hand dominant male adult volunteers will be included in this study.
Procedure:
Prior to the induction of WBV, control T-reflex recordings will be elicited and then the participants will complete a 15-s trial WBV protocol to familiarize themselves with the procedure. Following the control T-reflex recordings, the trial protocol and a 15-s rest, the participants will receive one session WBV. T-reflex will be recorded during WBV. Then, cold pack will be applied to the right ankle for 20 minutes. T-reflex will be recorded during the cooling of the ankle. Then, the participants will receive one session WBV, again. T-reflex will be recorded during WBV.
A light (2.9 gr.) triaxial (x, y and z-axis) accelerometer (LIS344ALH, ECOPACK®) will be taped on the right Achilles tendon so that the z-axis will be perpendicular with the direction of the tendon (Achilles accelerometer). A custom-made reflex hammer will be used to tap the right Achilles tendon just caudal to the accelerometer. The intensity of tapping will be about 19.6 N WBV frequencies of 35 Hz will be delivered for 60 s. The vibration plate of WBV device (Power-Plate®Pro5, PowerPlate® International, Ltd. London, UK) oscillates with a linear movement upward and downward. The participants will be barefooted and stand directly on the vibration platform. The surface electromyography (SEMG) data will be obtained while the participants stand upright on the vibration platform with the knees in extension. The Ag/AgCl electrodes (KENDALL®Covidien) with a disc radius of 10 mm will be placed 20 mm apart on the right soleus muscle belly on shaved skin in accordance with the recommendations of the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) project .
The recordings of both T-reflex and WBV-IMR will be acquired using SEMG. SEMG data will be recorded using a PowerLAB® data acquisition system (ADInstruments, Oxford, United Kingdom) and the data will be analyzed offline using the LabChart7® (ver 7.3.7, ADInstruments, Oxford, United Kingdom) software.
Precautions for voluntary muscle contractions and motion artifacts:
- the participants will be asked to use the handles of the WBV device to secure their balance. The sense of balance may impair during WBV. Therefore muscles may be activated to restore balance during WBV,
- before WBV trials, participants will be asked to relax and not to make voluntary contractions in their lower extremity muscles.
- a trial protocol will be applied to familiarize vibration,
- all cables will be carefully taped to the skin to minimize motion artifacts,
- all EMG recordings will be filtered to avoid WBV induced movement artifacts using a band pass filter from 60 to 500 Hz.
- Conditions
- Effects of Vibration
- Being tested
- vibration
- Keywords
- Whole body vibration, Bone myoregulation reflex, H-reflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrationOther
Also called Whole body vibration
Whole body vibration at 25Hz frequency
| Study group | Role | What they receive |
|---|---|---|
| WBV group | Experimental | whole-body vibration (WBV) group Receives: Other: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presynaptic Ia inhibition level
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start1 Nov 2017 (estimated)
- Primary completion17 Apr 2018 (estimated)
- Study completion17 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of VibrationStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016286
- Sponsor's protocol ID
- BMR20171
- Status last verified
- Jul 2017
- First submitted
- 8 Jan 2017
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cooling of Ankle on Bone Myoregulation Reflex Response and Presynaptic Ia Inhibition Level
- ClinicalTrials.gov ID
- NCT03016286
- Acronym / sponsor ID
- BMR20171
- Conditions
- Effects of Vibration
- Keywords
- Whole body vibration, Bone myoregulation reflex, H-reflex
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 17 Apr 2018 (estimated)
- Study completion
- 17 Apr 2018 (estimated)
- First posted
- 10 Jan 2017 (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.
Hypotheses of this study are
- Bone myoregulation reflex (BMR) inhibits presynaptically H-reflex during whole-body vibration (WBV)
- Cooling of ankle abolishes the inhibitor effect of BMR on soleus H-reflex Aim of this study is to test these hypotheses.
Methods: This study will be conducted on 10 healthy young adult males. WBV will be applied at 35 Hz frequencies with 2 mm amplitudes. Cold pack will be applied the right ankle for 20 minutes. The right soleus T-reflex will be recorded before WBV, during WBV, during cooling of the right ankle, and during WBV respectively.
Detailed description
Hypotheses of this study are
- Bone myoregulation reflex (BMR) inhibits presynaptically T-reflex during whole-body vibration (WBV)
- Cooling of ankle abolishes the inhibitor effect of BMR on soleus T-reflex Aim of this study is to test these hypotheses.
Methods:
Participants:
Ten young, healthy and right hand dominant male adult volunteers will be included in this study.
Procedure:
Prior to the induction of WBV, control T-reflex recordings will be elicited and then the participants will complete a 15-s trial WBV protocol to familiarize themselves with the procedure. Following the control T-reflex recordings, the trial protocol and a 15-s rest, the participants will receive one session WBV. T-reflex will be recorded during WBV. Then, cold pack will be applied to the right ankle for 20 minutes. T-reflex will be recorded during the cooling of the ankle. Then, the participants will receive one session WBV, again. T-reflex will be recorded during WBV.
A light (2.9 gr.) triaxial (x, y and z-axis) accelerometer (LIS344ALH, ECOPACK®) will be taped on the right Achilles tendon so that the z-axis will be perpendicular with the direction of the tendon (Achilles accelerometer). A custom-made reflex hammer will be used to tap the right Achilles tendon just caudal to the accelerometer. The intensity of tapping will be about 19.6 N WBV frequencies of 35 Hz will be delivered for 60 s. The vibration plate of WBV device (Power-Plate®Pro5, PowerPlate® International, Ltd. London, UK) oscillates with a linear movement upward and downward. The participants will be barefooted and stand directly on the vibration platform. The surface electromyography (SEMG) data will be obtained while the participants stand upright on the vibration platform with the knees in extension. The Ag/AgCl electrodes (KENDALL®Covidien) with a disc radius of 10 mm will be placed 20 mm apart on the right soleus muscle belly on shaved skin in accordance with the recommendations of the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles (SENIAM) project .
The recordings of both T-reflex and WBV-IMR will be acquired using SEMG. SEMG data will be recorded using a PowerLAB® data acquisition system (ADInstruments, Oxford, United Kingdom) and the data will be analyzed offline using the LabChart7® (ver 7.3.7, ADInstruments, Oxford, United Kingdom) software.
Precautions for voluntary muscle contractions and motion artifacts:
- the participants will be asked to use the handles of the WBV device to secure their balance. The sense of balance may impair during WBV. Therefore muscles may be activated to restore balance during WBV,
- before WBV trials, participants will be asked to relax and not to make voluntary contractions in their lower extremity muscles.
- a trial protocol will be applied to familiarize vibration,
- all cables will be carefully taped to the skin to minimize motion artifacts,
- all EMG recordings will be filtered to avoid WBV induced movement artifacts using a band pass filter from 60 to 500 Hz.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WBV group | Experimental | Other: vibrationwhole-body vibration (WBV) group |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male
- Right-handed men
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| vibrationAlso: Whole body vibrationWhole body vibration at 25Hz frequency | Other | WBV group |
Primary outcome
Presynaptic Ia inhibition level
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing vibration in people with Effects of Vibration, run by Bagcilar Training and Research Hospital.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Presynaptic Ia inhibition level (time frame: 1 month). 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 13 Jul 2017.