Vibration; ExposureNCT05209945
Whole Body Vibration and Tonic Vibration Reflex
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
- 7 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2021to 31 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
- 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: High-Frequency Whole Body Vibration Activates Tonic Vibration Reflex
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 our hypothesis, the reflex system activated by WBV changes depending on vibration frequency: if the high-frequency (100-150 Hz) WBV is applied, the tonic vibration reflex is activated; if the low-frequency (30-40 Hz) WBV is applied, the bone myoregulation reflex is activated. The purpose of this research is to test this hypothesis.
Read the detailed description
Seven healthy recreationally active males between the ages of 26 and 35 volunteered to participate in this study. All subjects received pre-study informed consent. All experimental procedures were designed with the Helsinki declaration in mind and approved by the local ethics committee. All subjects performed a familiarization trial to acclimate subjects to the WBV stimulus. WBV-IR and TVR latency of soleus muscle were then measured in the quiet standing position. The vibrations (WBV or tendon) sequence were applied randomly to negate any order/time effect. The subject rested for five minutes between the WBV and tendon vibration. The WBV application was delivered using a PowerPlate Pro5 device (PowerPlate International, Amsterdam, The Netherlands). First, 30 Hz, low amplitude (1 mm) vibration with a duration of 30 seconds was applied to each subject for familiarization purposes. After three minutes of rest, low-amplitude (1 mm) WBV testing was performed in random order in quiet standing positions. In a WBV set, three different vibration frequencies (30, 35, and 40 Hz), each lasting for 30 s with 3-s rest intervals, were delivered. The local vibration was applied to the mid-point of the right Achilles tendon by using a custom-made vibrator. The head of the tendon vibrator was in light contact with the underlying skin. Tendon vibrations were applied by the same researcher. Three different vibration frequencies (100, 135, and 150 Hz) were delivered, lasting for 30 s with 3-s rest intervals. A local vibration was applied to the right heel using the same custom-made vibrator. Tendon vibrations were applied by the same researcher. Three different vibration frequencies (100, 135, and 150 Hz) were delivered, lasting for 30 s with 3-s rest intervals.
The surface electromyography (SEMG) recorded from the soleus and acceleration data were collected simultaneously using data acquisition and analysis system (PowerLab ® software, ADInstruments, Oxford, UK). Disposable self-adhesive bipolar Ag/AgCl (Covidien Kendall, Dublin, Ireland) surface electrodes were placed on the right soleus belly 4 cm apart. The skin overlying the muscle was shaved, light abrasion was applied, and the skin was cleaned with alcohol to reduce the skin resistance. To determine TVR latency, a light (2.9 g) piezoelectric accelerometer (LIS344ALH, ECOPACK®, Mansfield, TX, USA) was firmly fixed using adhesive tape on the skin overlying the right Achilles tendon. To determine WBV-IR latency, an identical accelerometer was firmly mounted on the WBV platform. The acceleration and SEMG signals were recorded at a sampling frequency of 20 kHz. Accelerometer recordings were filtered with a high-pass filter set at 5 Hz. SEMG data obtained during WBV were bandpass filtered at 80-500 Hz to reduce vibration-induced movement artifacts and then full-wave rectified. Similarly, SEMG data obtained during tendon vibration were bandpass filtered at 160-500 Hz and then full-wave rectified. WBV-IR and TVR latencies were then calculated by using the cumulative average method.
An electronic reflex hammer (Elcon, Germany) was used to determine T-reflex latency. 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, tonic vibration reflex
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, heel and soleus tendon vibrations were applied to the human body
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | Vibration (WBV, heel, and tendon vibration) was 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: during intervention, an average of 1 minute
TVR latency
Tonic vibration reflex latency
Measured: during intervention, an average of 1 minute
Heel vibration induced reflex latency
Vibration was applied to the right heel. The reflex latency induced by the heel vibration was measured.
Measured: during intervention, an average of 1 minute
T-reflex latency
Latency of the Achilles tendon reflex
Measured: during intervention, an average of 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start27 Nov 2021
- Primary completion30 Dec 2021
- Study completion31 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
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 7 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, Study chair, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209945
- Sponsor's protocol ID
- WBVTVR
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 27 Jan 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 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency Whole Body Vibration Activates Tonic Vibration Reflex
- ClinicalTrials.gov ID
- NCT05209945
- Acronym / sponsor ID
- WBVTVR
- Conditions
- Vibration; Exposure, Muscle Physiology
- Keywords
- muscle strength, vibration, tonic vibration reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 Jan 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 our hypothesis, the reflex system activated by WBV changes depending on vibration frequency: if the high-frequency (100-150 Hz) WBV is applied, the tonic vibration reflex is activated; if the low-frequency (30-40 Hz) WBV is applied, the bone myoregulation reflex is activated. The purpose of this research is to test this hypothesis.
Detailed description
Seven healthy recreationally active males between the ages of 26 and 35 volunteered to participate in this study. All subjects received pre-study informed consent. All experimental procedures were designed with the Helsinki declaration in mind and approved by the local ethics committee. All subjects performed a familiarization trial to acclimate subjects to the WBV stimulus. WBV-IR and TVR latency of soleus muscle were then measured in the quiet standing position. The vibrations (WBV or tendon) sequence were applied randomly to negate any order/time effect. The subject rested for five minutes between the WBV and tendon vibration. The WBV application was delivered using a PowerPlate Pro5 device (PowerPlate International, Amsterdam, The Netherlands). First, 30 Hz, low amplitude (1 mm) vibration with a duration of 30 seconds was applied to each subject for familiarization purposes. After three minutes of rest, low-amplitude (1 mm) WBV testing was performed in random order in quiet standing positions. In a WBV set, three different vibration frequencies (30, 35, and 40 Hz), each lasting for 30 s with 3-s rest intervals, were delivered. The local vibration was applied to the mid-point of the right Achilles tendon by using a custom-made vibrator. The head of the tendon vibrator was in light contact with the underlying skin. Tendon vibrations were applied by the same researcher. Three different vibration frequencies (100, 135, and 150 Hz) were delivered, lasting for 30 s with 3-s rest intervals. A local vibration was applied to the right heel using the same custom-made vibrator. Tendon vibrations were applied by the same researcher. Three different vibration frequencies (100, 135, and 150 Hz) were delivered, lasting for 30 s with 3-s rest intervals.
The surface electromyography (SEMG) recorded from the soleus and acceleration data were collected simultaneously using data acquisition and analysis system (PowerLab ® software, ADInstruments, Oxford, UK). Disposable self-adhesive bipolar Ag/AgCl (Covidien Kendall, Dublin, Ireland) surface electrodes were placed on the right soleus belly 4 cm apart. The skin overlying the muscle was shaved, light abrasion was applied, and the skin was cleaned with alcohol to reduce the skin resistance. To determine TVR latency, a light (2.9 g) piezoelectric accelerometer (LIS344ALH, ECOPACK®, Mansfield, TX, USA) was firmly fixed using adhesive tape on the skin overlying the right Achilles tendon. To determine WBV-IR latency, an identical accelerometer was firmly mounted on the WBV platform. The acceleration and SEMG signals were recorded at a sampling frequency of 20 kHz. Accelerometer recordings were filtered with a high-pass filter set at 5 Hz. SEMG data obtained during WBV were bandpass filtered at 80-500 Hz to reduce vibration-induced movement artifacts and then full-wave rectified. Similarly, SEMG data obtained during tendon vibration were bandpass filtered at 160-500 Hz and then full-wave rectified. WBV-IR and TVR latencies were then calculated by using the cumulative average method.
An electronic reflex hammer (Elcon, Germany) was used to determine T-reflex latency. 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
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Vibration | Experimental | Procedure: vibrationVibration (WBV, heel, and tendon vibration) was 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
- 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, heel and soleus tendon vibrations were applied to the human body | Procedure or surgery | Vibration |
Primary outcome
WBV-IR latency
Time frame: during intervention, an average of 1 minute
Whole-body vibration induced reflex latency
TVR latency
Time frame: during intervention, an average of 1 minute
Tonic vibration reflex latency
Heel vibration induced reflex latency
Time frame: during intervention, an average of 1 minute
Vibration was applied to the right heel. The reflex latency induced by the heel vibration was measured.
T-reflex latency
Time frame: during intervention, an average of 1 minute
Latency of the Achilles tendon reflex
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 27 Jan 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 study chair
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 27 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?
WBV-IR latency (time frame: during intervention, an average of 1 minute). The study lists 4 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 27 Jan 2022.