Reflex, Ankle, DecreasedWBV-IRMNCT04516798
The Reflex Mechanism Underlying Neuromuscular Effects Of The Whole Body Vibration
A study testing vibration in people with Reflex, Ankle, Decreased, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine whether the spinal reflex mechanism underlying the neuromuscular effects of whole body vibration (WBV) is tonic vibration reflex. Local and whole body vibration reflex latencies were measured in young adult healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reflex, Ankle, Decreased
- What is being tested?
- vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2020to 7 Oct 2020
- 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
- Healthy
- Young adult (20-40 years old)
- Both gender
- Volunteer
Who cannot join
- Cardiac disorder (Rhythm / conduction disorder, Cardiac pacemaker, Ischemic heart disease)
- Finding or suspected active deep vein thrombosis,
- History of deep vein thrombosis and pulmonary embolism,
- Orthostatic hypotension
- Hypertension
- Presence of fracture in the lower limb
Show all 15Show fewer
- Achilles Contractures
- Active inflammatory, rheumatological or infectious disease in the lower limb
- Peripheral nerve lesions such as polyneuropathy, radiculopathy in the lower limb
- Those with a history of Achilles tendinopathy / bursitis
- Those with a history of kidney stones
- Patients with dizziness and balance problems,
- Cases with lesions on the skin surface where electrodes were attached
- Those with communication-cooperation problems
- Having a history of panic attacks
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: The Reflex Mechanism Underlying The Neuromuscular Effects Of The Whole Body Vibration
This study was conducted to determine whether the spinal reflex mechanism underlying the neuromuscular effects of whole body vibration (WBV) is tonic vibration reflex. Local and whole body vibration reflex latencies were measured in young adult healthy volunteers.
Read the detailed description
A total of eight volunteers were included according to the inclusion and exclusion criteria. The subjects were vibrated while standing upright with the WBV device (PowerPlate® Pro5). The 30, 35 and 40 Hz WBVs were applied for thirty seconds for each frequency with an amplitude of 2 mm. In the same session, 100, 135 and 150 Hz local vibrations were applied to the right Achilles tendon for thirty seconds for each frequency. 100, 135 and 150 Hz local vibrations were then applied to the right heel for thirty seconds for each frequency with an interval of five seconds. Vibration stimuli were recorded accelerometers. Reflex muscle responses were recorded from the right soleus muscle at a sampling rate of 40 KHz. Recording electrodes were placed on the belly of the right soleus muscle and the ground electrode was placed on the right medial malleolus.
The data were recorded with the PowerLab device, the records were processed and analyzed offline from the LabChart program. After the EMG records are filtered and rectified, reflex latencies were measured by cumulative averaging method using the accelerometer records as triggers (Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Türker KS.A new method to determine reflex latency induced by high rate stimulation of the nervous system.Front Hum Neurosci.2014 Jul 18; 8: 536.doi: 10.3389 / fnhum.2014.00536). After determining the Achilles tendon vibration reflex latency and the reflex latency induced by WBV, it was compared with statistical methods.
- Conditions
- Reflex, Ankle, Decreased
- Being tested
- vibration
- Keywords
- whole body vibration, tonic vibration reflex, muscle spindle
- Medical subject headings
- Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrationOther
local and whole-body vibration were applied
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Local and whole body vibration were applied Receives: Other: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
reflex latency
The time between the vibration stimulus and the reflex muscle response triggered by it was defined as the latency.
Measured: during intervention, an average of 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start5 Oct 2020
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Reflex, Ankle, DecreasedStudies 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 experimental study
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilhan Karacan, Assoc Prof, Principal investigator, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516798
- Sponsor's protocol ID
- ISTANBULPMR
- Acronym
- WBV-IRM
- Status last verified
- Oct 2020
- First submitted
- 14 Aug 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildirim MA, Topkara B, Aydin T, Paker N, Soy D, Coskun E, Ones K, Bardak A, Kesiktas N, Ozyurt MG, Celik B, Onder B, Kilic A, Kucuk HC, Karacan I, Turker KS. Exploring the receptor origin of vibration-induced reflexes. Spinal Cord. 2020 Jun;58(6):716-723. doi: 10.1038/s41393-020-0419-5. Epub 2020 Jan 15.
PubMed 31942042Aydin T, Kesiktas FN, Baskent A, Karan A, Karacan I, Turker KS. Cross-training effect of chronic whole-body vibration exercise: a randomized controlled study. Somatosens Mot Res. 2020 Jun;37(2):51-58. doi: 10.1080/08990220.2020.1720635. Epub 2020 Feb 5.
PubMed 32024411Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
PubMed 25100978
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reflex Mechanism Underlying The Neuromuscular Effects Of The Whole Body Vibration
- ClinicalTrials.gov ID
- NCT04516798
- Acronym / sponsor ID
- WBV-IRM / ISTANBULPMR
- Conditions
- Reflex, Ankle, Decreased
- Keywords
- whole body vibration, tonic vibration reflex, muscle spindle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 18 Aug 2020 (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.
This study was conducted to determine whether the spinal reflex mechanism underlying the neuromuscular effects of whole body vibration (WBV) is tonic vibration reflex. Local and whole body vibration reflex latencies were measured in young adult healthy volunteers.
Detailed description
A total of eight volunteers were included according to the inclusion and exclusion criteria. The subjects were vibrated while standing upright with the WBV device (PowerPlate® Pro5). The 30, 35 and 40 Hz WBVs were applied for thirty seconds for each frequency with an amplitude of 2 mm. In the same session, 100, 135 and 150 Hz local vibrations were applied to the right Achilles tendon for thirty seconds for each frequency. 100, 135 and 150 Hz local vibrations were then applied to the right heel for thirty seconds for each frequency with an interval of five seconds. Vibration stimuli were recorded accelerometers. Reflex muscle responses were recorded from the right soleus muscle at a sampling rate of 40 KHz. Recording electrodes were placed on the belly of the right soleus muscle and the ground electrode was placed on the right medial malleolus.
The data were recorded with the PowerLab device, the records were processed and analyzed offline from the LabChart program. After the EMG records are filtered and rectified, reflex latencies were measured by cumulative averaging method using the accelerometer records as triggers (Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Türker KS.A new method to determine reflex latency induced by high rate stimulation of the nervous system.Front Hum Neurosci.2014 Jul 18; 8: 536.doi: 10.3389 / fnhum.2014.00536). After determining the Achilles tendon vibration reflex latency and the reflex latency induced by WBV, it was compared with statistical methods.
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 experimental study
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: vibrationLocal and whole body vibration were applied |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Young adult (20-40 years old)
- Both gender
- Volunteer
Key exclusion criteria (15 listed)
- Cardiac disorder (Rhythm / conduction disorder, Cardiac pacemaker, Ischemic heart disease)
- Finding or suspected active deep vein thrombosis,
- History of deep vein thrombosis and pulmonary embolism,
- Orthostatic hypotension
- Hypertension
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 |
|---|---|---|
| vibrationlocal and whole-body vibration were applied | Other | Experiment |
Primary outcome
reflex latency
Time frame: during intervention, an average of 8 minutes
The time between the vibration stimulus and the reflex muscle response triggered by it was defined as the 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 27 Oct 2020.
- Results publication: PubMed 31942042Yildirim MA, Topkara B, Aydin T, Paker N, Soy D, Coskun E, Ones K, Bardak A, Kesiktas N, Ozyurt MG, Celik B, Onder B, Kilic A, Kucuk HC, Karacan I, Turker KS. Exploring the receptor origin of vibration-induced reflexes. Spinal Cord. 2020 Jun;58(6):716-723. doi: 10.1038/s41393-020-0419-5. Epub 2020 Jan 15.
- Results publication: PubMed 32024411Aydin T, Kesiktas FN, Baskent A, Karan A, Karacan I, Turker KS. Cross-training effect of chronic whole-body vibration exercise: a randomized controlled study. Somatosens Mot Res. 2020 Jun;37(2):51-58. doi: 10.1080/08990220.2020.1720635. Epub 2020 Feb 5.
- Results publication: PubMed 25100978Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
- Individual participant dataSharing planned: No
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.
Ilhan Karacan, Assoc Prof 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 Reflex, Ankle, Decreased, 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 4 inclusion and 15 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 Oct 2020. 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?
reflex latency (time frame: during intervention, an average of 8 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516798, which also lists 3 linked publications.
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 Oct 2020.