Vibration; ExposureNCT05221541
Feature of Reflex Pathway Activated by WBV and Voluntary Contraction
A study testing vibration in people with Vibration; Exposure and Muscle Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Whole-body vibration (WBV) has beneficial neuromuscular effects on muscle strength increase. Supraspinal, spinal, and peripheral mechanisms have been proposed to explain these beneficial effects. The most commonly proposed explanatory mechanism is spinal segmental reflexes. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vibration; Exposure, Muscle Physiology
- What is being tested?
- vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2021to 22 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
Who cannot join
- Scar, dermatitis, etc. in the skin tissue where the surface EMG electrode will be placed
- Kidney stone history
- Fracture in the lower extremity, history of orthopedic surgery
- Heart disease, Hypertension
- Dizziness
- Metabolic bone diseases, including osteoporosis
Show all 11Show fewer
- History of bone occupying lesion, neoplasia, osteomyelitis
- Degenerative, inflammatory diseases of the joints of the lower extremities
- Lower extremity thrombophlebitis
- Lower extremity motor loss, sensory loss, muscle atrophy
- Subjects who cannot tolerate whole-body vibration
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: Is the Reflex Pathway Activated by Whole-body Vibration Change in Case of Voluntary Contraction?
Whole-body vibration (WBV) has beneficial neuromuscular effects on muscle strength increase. Supraspinal, spinal, and peripheral mechanisms have been proposed to explain these beneficial effects. The most commonly proposed explanatory mechanism is spinal segmental reflexes. However, the neuronal circuit and receptors of the reflex response have not been defined precisely. A group of researchers found that the reflex system is the Tonic vibration reflex (TVR) under the neuromuscular effects of WBV; Other researchers claim that WBV activates a different spinal reflex than TVR.
Tonic vibration reflex is a polysynaptic reflex that occurs as a result of muscle spindle activation, in which more than 100 Hz vibrations are applied to the belly or tendon of the muscle.
Read more
A group of researchers argues that WBV activates the spinal reflex response, but this reflex response is different from TVR. According to them, WBV-induced reflex (WBV-IR) response latency is longer than TVR latency. WBV activates TVR at very attenuated amplitude; WBV activates a different spinal reflex with longer latency at medium and high amplitude vibration. They reported that although the H-reflex, T-reflex, and TVR latency was longer in the spastic soleus muscle than normotonic soleus muscle, where the muscle spindle and Ia afferent pathway were hyperactive. However, the WBV-IR latency was similar in both spastic and normotonic soleus muscle.
According to hypothesis of the present study , the reflex system activated by WBV changes depending on whether there is voluntary contraction or not: if the vibration is applied during voluntary contraction, the tonic vibration reflex is activated; In the absence of voluntary contraction (when the muscle is at rest), the bone myoregulation reflex is activated. The purpose of this research is to test this hypothesis.
Read the detailed description
Subjects will be performed WBV in a semi-squatting position and standing upright, and soleus reflex latency will be detected by surface EMG during WBV. TVR latency will be measured by performing Achilles tendon vibration. Achilles tendon reflex latency will also be measured.
The WBV will be applied with the PowerPlate® Pro5 (London UK). The vibration amplitude will be 4 mm. The vibration frequency will be 30, 35, 40 Hz. Each vibration frequency will be applied for the 30s. A 10s rest period will be applied between vibrations of 30 seconds. This test vibration application will be performed in a semi-squatting position and standing upright. Subjects will be administered WBV for familiarisation prior to administration of WBV for testing purposes.
A surface EMG recording will be taken from the right soleus muscle belly. A pair of self-adhesive Ag/AgCl (KENDALL® Covidien, Massachusetts, USA) self-adhesive electrodes will have adhered to the skin. The surface EMG recordings will be made with a PowerLab ® (ADInstruments ADInstruments, Oxford, UK) data recorder with a sample rate of 40 kHz. EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK).
For reflex latency calculation, piezo-electric accelerometers (LIS344ALH, ECOPACK®, Mansfield, TX, USA) will be fixed on the WBV device platform and on the right Achilles tendon. The acceleration data will be recorded with the PowerLab (ADInstruments London) data acquisition simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 40 kHz.
An electronic reflex hammer (Elcon, Germany) was used to determine T-reflex latency.
WBV-IMR and TVR latencies were then calculated by using the cumulative average method. All latencies were normalized to the body height of each participant. Latency was expressed as milliseconds (ms).
- Conditions
- Vibration; Exposure, Muscle Physiology
- Being tested
- vibration
- Keywords
- muscle strength, vibration, reflex pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrationProcedure or surgery
whole-body vibration and soleus tendon vibration will be applied to participants
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | Vibration (WBV and Tendon vibration) will be applied to participants Receives: Procedure: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
WBV-IR latency
Whole-body vibration induced reflex latency
Measured: 1 day
TVR latency
Tonic vibration reflex latency
Measured: 1 day
T-reflex latency
The Achilles tendon reflex latency
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 posted3 Feb 2022
- Study start16 Dec 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vibration; ExposureStudies 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
- Parallel group study design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan KARACAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- İLHAN KARACAN, Principal investigator, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221541
- Sponsor's protocol ID
- TVRBMR
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Reflex Pathway Activated by Whole-body Vibration Change in Case of Voluntary Contraction?
- ClinicalTrials.gov ID
- NCT05221541
- Acronym / sponsor ID
- TVRBMR
- Conditions
- Vibration; Exposure, Muscle Physiology
- Keywords
- muscle strength, vibration, reflex pathway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 3 Feb 2022 (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.
Whole-body vibration (WBV) has beneficial neuromuscular effects on muscle strength increase. Supraspinal, spinal, and peripheral mechanisms have been proposed to explain these beneficial effects. The most commonly proposed explanatory mechanism is spinal segmental reflexes. However, the neuronal circuit and receptors of the reflex response have not been defined precisely. A group of researchers found that the reflex system is the Tonic vibration reflex (TVR) under the neuromuscular effects of WBV; Other researchers claim that WBV activates a different spinal reflex than TVR.
Tonic vibration reflex is a polysynaptic reflex that occurs as a result of muscle spindle activation, in which more than 100 Hz vibrations are applied to the belly or tendon of the muscle.
A group of researchers argues that WBV activates the spinal reflex response, but this reflex response is different from TVR. According to them, WBV-induced reflex (WBV-IR) response latency is longer than TVR latency. WBV activates TVR at very attenuated amplitude; WBV activates a different spinal reflex with longer latency at medium and high amplitude vibration. They reported that although the H-reflex, T-reflex, and TVR latency was longer in the spastic soleus muscle than normotonic soleus muscle, where the muscle spindle and Ia afferent pathway were hyperactive. However, the WBV-IR latency was similar in both spastic and normotonic soleus muscle.
According to hypothesis of the present study , the reflex system activated by WBV changes depending on whether there is voluntary contraction or not: if the vibration is applied during voluntary contraction, the tonic vibration reflex is activated; In the absence of voluntary contraction (when the muscle is at rest), the bone myoregulation reflex is activated. The purpose of this research is to test this hypothesis.
Detailed description
Subjects will be performed WBV in a semi-squatting position and standing upright, and soleus reflex latency will be detected by surface EMG during WBV. TVR latency will be measured by performing Achilles tendon vibration. Achilles tendon reflex latency will also be measured.
The WBV will be applied with the PowerPlate® Pro5 (London UK). The vibration amplitude will be 4 mm. The vibration frequency will be 30, 35, 40 Hz. Each vibration frequency will be applied for the 30s. A 10s rest period will be applied between vibrations of 30 seconds. This test vibration application will be performed in a semi-squatting position and standing upright. Subjects will be administered WBV for familiarisation prior to administration of WBV for testing purposes.
A surface EMG recording will be taken from the right soleus muscle belly. A pair of self-adhesive Ag/AgCl (KENDALL® Covidien, Massachusetts, USA) self-adhesive electrodes will have adhered to the skin. The surface EMG recordings will be made with a PowerLab ® (ADInstruments ADInstruments, Oxford, UK) data recorder with a sample rate of 40 kHz. EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK).
For reflex latency calculation, piezo-electric accelerometers (LIS344ALH, ECOPACK®, Mansfield, TX, USA) will be fixed on the WBV device platform and on the right Achilles tendon. The acceleration data will be recorded with the PowerLab (ADInstruments London) data acquisition simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 40 kHz.
An electronic reflex hammer (Elcon, Germany) was used to determine T-reflex latency.
WBV-IMR and TVR latencies were then calculated by using the cumulative average method. All latencies were normalized to the body height of each participant. Latency was expressed as milliseconds (ms).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Parallel group study design
| Arm | Type | Receives |
|---|---|---|
| Vibration | Experimental | Procedure: vibrationVibration (WBV and Tendon vibration) will be applied to participants |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
Key exclusion criteria (11 listed)
- Scar, dermatitis, etc. in the skin tissue where the surface EMG electrode will be placed
- Kidney stone history
- Fracture in the lower extremity, history of orthopedic surgery
- Heart disease, Hypertension
- Dizziness
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 |
|---|---|---|
| vibrationwhole-body vibration and soleus tendon vibration will be applied to participants | Procedure or surgery | Vibration |
Primary outcome
WBV-IR latency
Time frame: 1 day
Whole-body vibration induced reflex latency
TVR latency
Time frame: 1 day
Tonic vibration reflex latency
T-reflex latency
Time frame: 1 day
The Achilles tendon reflex latency
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 Feb 2022.
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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 vibration in people with Vibration; Exposure and Muscle Physiology, 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 11 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 Feb 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?
WBV-IR latency (time frame: 1 day). The study lists 3 primary outcomes in all. 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 Feb 2022.