HealthyNCT01433341
Evaluation of Postural Control After Exercise in Athletes Using Tetra Axial Posturography (tetrax1)
An observational study of Healthy, run by Meir Medical Center at 1 site in Israel.
Trial summary
Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of electronic signals emitted by four footplates, one for each heel and toe, respectively. Read more about this study
- Who is it for?
- Ages 12 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2012to Oct 2013
- Phase
- Observational
- 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 12 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Thirty basketball and football players between the ages of 12 and 18 years old.
Who may be able to join
- age 12-18 years
- healthy athletes
Who cannot join
- children with known disturbances in bone, muscle of nervous systems
- children using medications that may cause problems in balance or coordination
Trial locations and contacts
1 site in 1 country.
About this study
Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of electronic signals emitted by four footplates, one for each heel and toe, respectively. These are sensitive to vertical pressure produced by a subject standing straight but in various positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields additional parameters not obtained by the traditional monoplate stabilometers, namely, weight-distribution patterns and correlation among six combinations of paired outputs from the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric synchronizations).
Most athletic injuries occur at the end of an activity, when the participant is fatigue. It is likely that significant portion of the injuries result from instability of the lower extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue increase postural sway, impaired muscle control, and increase the onset delay of movement. Comparing pre-exercise with post-exercise results for each athlete, should detect significant and clinically meaningful differences with the Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and synchronizations of toe parts. The method is suitable for young subjects, and the equipment is portable and tests can be conveniently carried out in a child's familiar training setting and right before/after exercise.
The goal of the present study is to measure the balance of the athletes after different types of exercises, to measure the ability of the athletes to recover different types of exercises, and to measure the influence of increasing physical fitness on balance ability. Fifty basketball and football players between the ages of 12 and 18 years old will be examined following informed consent from the children and their legal guardian. Each participant would be measured three times during the year (pre-season, middle-season, and post-season), three times each (before-training, after aerobic warming-up, and after-training) on the Tetrax. Additionally, physical parameters (as height, and weight), anatomical parameters (as leg length), and joint range of movement, would be record.
- Conditions
- Healthy
- Keywords
- Normal young athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young athletes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posturography measures
changes in posturography measures in athletes throughout a training season
Measured: Training season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433341
- Sponsor's protocol ID
- MeirMc06611TIL
- Status last verified
- Nov 2013
- First submitted
- 12 Sep 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postural Control After Exercise in Athletes Using Tetra Axial Posturography (tetrax1)
- ClinicalTrials.gov ID
- NCT01433341
- Acronym / sponsor ID
- MeirMc06611TIL
- Conditions
- Healthy
- Keywords
- Normal young athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Sep 2011 (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.
Tetra-ataxiametric posturography is based on the measurement and computerized elaboration of electronic signals emitted by four footplates, one for each heel and toe, respectively. These are sensitive to vertical pressure produced by a subject standing straight but in various positions (feet parallel, in tandem, eyes closed, on pads, etc.). The method yields additional parameters not obtained by the traditional monoplate stabilometers, namely, weight-distribution patterns and correlation among six combinations of paired outputs from the two heels, two toes, heel/toe of each foot, and the two diagonals (tetra-ataxiametric synchronizations).
Most athletic injuries occur at the end of an activity, when the participant is fatigue. It is likely that significant portion of the injuries result from instability of the lower extremity joints as a consequence of fatigue of the stabilizing muscles. Muscle fatigue increase postural sway, impaired muscle control, and increase the onset delay of movement. Comparing pre-exercise with post-exercise results for each athlete, should detect significant and clinically meaningful differences with the Tetra-ataxiametric measures of stability, interaction between Fourier Spectral Power Ranges of body sway, weight distributions, and synchronizations of toe parts. The method is suitable for young subjects, and the equipment is portable and tests can be conveniently carried out in a child's familiar training setting and right before/after exercise.
The goal of the present study is to measure the balance of the athletes after different types of exercises, to measure the ability of the athletes to recover different types of exercises, and to measure the influence of increasing physical fitness on balance ability. Fifty basketball and football players between the ages of 12 and 18 years old will be examined following informed consent from the children and their legal guardian. Each participant would be measured three times during the year (pre-season, middle-season, and post-season), three times each (before-training, after aerobic warming-up, and after-training) on the Tetrax. Additionally, physical parameters (as height, and weight), anatomical parameters (as leg length), and joint range of movement, would be record.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young athletes | – | – |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Thirty basketball and football players between the ages of 12 and 18 years old.
Key inclusion criteria (2 listed)
- age 12-18 years
- healthy athletes
Key exclusion criteria (2 listed)
- children with known disturbances in bone, muscle of nervous systems
- children using medications that may cause problems in balance or coordination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Posturography measures
Time frame: Training season
changes in posturography measures in athletes throughout a training season
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 13 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Meir Medical Center at 1 site in Israel.
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 2 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 13 Nov 2013. 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 Israel. 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?
Posturography measures (time frame: Training season). 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 Nov 2013.