HealthyNCT02121093
Effect of Vibration Stimulation Applied to Different Frequencies in Cortical Excitability and Muscular Function: Randomised Clinical Trial
A study testing vibration in people with Healthy, run by Universidade do Vale do Paraíba at 1 site in Brazil.
Trial summary
The vibration stimulation is regarded as a new method of training and therapy to change afferent parts and cortical projections, which are important for motor control. This study aims to check effects of different frequency parameters for electrical cortical potentials and electrical muscular potentials in healthy… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- May 2014to Jul 2014
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically and mentally healthy
- Right-handed volunteers who are not using psychoactive or psychotropic substances,
- Have nourished themselves up to three hours before the experiment.
Who cannot join
- Under 18-year- and over-60-old volunteers
- who do not fit into using data collection equipment,
- individuals who have slept less than six to eight hours the night before the experiment,
- who have already undergone vibration training and had problems with using it.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Janaina de Moraes Silva
Teresina, Piauí, 64020290
janaina silva, 558699317552, fisiojanainams@gmail.com
janaina, 558699317552, fisiojanainams@gmail.com
About this study
The vibration stimulation is regarded as a new method of training and therapy to change afferent parts and cortical projections, which are important for motor control. This study aims to check effects of different frequency parameters for electrical cortical potentials and electrical muscular potentials in healthy young adults. 80 volunteers will participate in the study, and they will be randomly subdivided in four groups for trials. The methodology consists of electroencephalographic and electromyographic assessment before and after 15-minute vibration application with a digital vibratory pad.
Read the detailed description
The vibratory stimulation is regarded as a new training method and capable of modulating peripheral afferents and cortical projections therapy, which are important in motor control. This study aims to determine the effects of different parameters on cortical frequency electric potential and electric potential muscle in healthy young adults. Will participate in the study 80 volunteers, these randomly divided into four groups for the experimental procedures. The methodological approach consists of an electroencephalographic and electromyographic evaluation before and after 15 minutes of application of vibration through a digital vibrating pad.
- Conditions
- Healthy
- Being tested
- vibration
- Keywords
- vibration, physiotherapy, cortex, muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| alpha band of the EEG and electromyographic activity | No intervention | - 20 will be in the evaluation group (EG); then review the alpha band of EEG and EMG activity. |
| Vibration | Experimental | * • 20 vai participar no grupo de baixa freqüência de vibração estimulação (LFVS);
* 20 no grupo de estimulação da vibração de média freqüência (MFVS);
* 20 vai participar no grupo de alta freqüência de vibração estimulação (HFVS). then review the alpha band of EEG and EMG activity. Receives: Procedure: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
We know that the vibration has multiple physiologic effects, promoting normal patterns of motor activity by changing motor-neuron excitability. Vibrations increase the final afferent influx of the primary muscular fuse, allowing the reflex contraction, the so-called tonic vibration reflex . This reflex is mediated by both segmental and supra-segmental spine path, and is supported by upper centres.
Measured: 1 month
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
The 80 volunteers will be randomly gathered in study groups by random computer-given numbers.
From these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).
Measured: 1 month
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
The 80 volunteers will be randomly gathered in study groups by random computer-given numbers.
From these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).
The three groups is intended to observe increased alpha band
Measured: 1 month
Secondary outcomes (1)
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
The 80 volunteers will be randomly gathered in study groups by random computer-given numbers.
From these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).
The three groups is intended to observe increased electromyographic activity of the muscles
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 posted23 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izabela dos Santos Mendes, Universidade do Vale do Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121093
- Sponsor's protocol ID
- janaina de moraes silva
- Status last verified
- Apr 2014
- First submitted
- 7 Apr 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibration Stimulation Applied to Different Frequencies in Cortical Excitability and Muscular Function: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02121093
- Acronym / sponsor ID
- janaina de moraes silva
- Conditions
- Healthy
- Keywords
- vibration, physiotherapy, cortex, muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 23 Apr 2014 (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 vibration stimulation is regarded as a new method of training and therapy to change afferent parts and cortical projections, which are important for motor control. This study aims to check effects of different frequency parameters for electrical cortical potentials and electrical muscular potentials in healthy young adults. 80 volunteers will participate in the study, and they will be randomly subdivided in four groups for trials. The methodology consists of electroencephalographic and electromyographic assessment before and after 15-minute vibration application with a digital vibratory pad.
Detailed description
The vibratory stimulation is regarded as a new training method and capable of modulating peripheral afferents and cortical projections therapy, which are important in motor control. This study aims to determine the effects of different parameters on cortical frequency electric potential and electric potential muscle in healthy young adults. Will participate in the study 80 volunteers, these randomly divided into four groups for the experimental procedures. The methodological approach consists of an electroencephalographic and electromyographic evaluation before and after 15 minutes of application of vibration through a digital vibrating pad.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha band of the EEG and electromyographic activity | No intervention | –- 20 will be in the evaluation group (EG); then review the alpha band of EEG and EMG activity. |
| Vibration | Experimental | Procedure: vibration* • 20 vai participar no grupo de baixa freqüência de vibração estimulação (LFVS); * 20 no grupo de estimulação da vibração de média freqüência (MFVS); * 20 vai participar no grupo de alta freqüência de vibração estimulação (HFVS). then review the alpha band of EEG and EMG activity. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Physically and mentally healthy
- Right-handed volunteers who are not using psychoactive or psychotropic substances,
- Have nourished themselves up to three hours before the experiment.
Key exclusion criteria (4 listed)
- Under 18-year- and over-60-old volunteers
- who do not fit into using data collection equipment,
- individuals who have slept less than six to eight hours the night before the experiment,
- who have already undergone vibration training and had problems with using it.
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 |
|---|---|---|
| vibration | Procedure or surgery | Vibration |
Primary outcome
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
Time frame: 1 month
We know that the vibration has multiple physiologic effects, promoting normal patterns of motor activity by changing motor-neuron excitability. Vibrations increase the final afferent influx of the primary muscular fuse, allowing the reflex contraction, the so-called tonic vibration reflex . This reflex is mediated by both segmental and supra-segmental spine path, and is supported by upper centres.
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
Time frame: 1 month
The 80 volunteers will be randomly gathered in study groups by random computer-given numbers. From these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
Time frame: 1 month
The 80 volunteers will be randomly gathered in study groups by random computer-given numbers. From these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS). The three groups is intended to observe increased alpha band
1 secondary outcome
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial
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 23 Apr 2014.
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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.
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 Healthy, run by Universidade do Vale do Paraíba at 1 site in Brazil.
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 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 23 Apr 2014. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact janaina silva (558699317552, fisiojanainams@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial (time frame: 1 month). 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 23 Apr 2014.