Gymnastics Injury, Motor Learning, BalanceEarly Phase 1NCT00374569
Dynamic Posturographic Testing and Motor Learning Predictability in Gymnasts
A Early Phase 1 study testing Gymnastic Routine in people with Gymnastics Injury, Motor Learning, Balance, run by Carrick Institute for Graduate Studies at 1 site in United States.
Trial summary
One aim of this study was to find if there was a difference between balance and stability between elite level gymnasts and non-gymnasts. Another aim was to find if there was a relationship between dynamic posturographic scores associated with sway fatigue or adaptability and the ability to learn new gymnastic… Read more about this study
- Who is it for?
- Ages 10 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gymnastics Injury, Motor Learning, Balance
- What is being tested?
- Gymnastic Routine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Sep 2006
- Phase
- Early Phase 1
- 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 10 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Elite level Gymnasts
- Non Gymasts control
Who cannot join
- Non Elite level Gymnasts
Trial locations and contacts
1 site in 1 country.
United States1 site
Carrick Institute for Graduate Studies Texas
Dallas, Texas, 75267
About this study
One aim of this study was to find if there was a difference between balance and stability between elite level gymnasts and non-gymnasts. Another aim was to find if there was a relationship between dynamic posturographic scores associated with sway fatigue or adaptability and the ability to learn new gymnastic routines. The ultimate aim of the study was to improve gymnastic performance while reducing the probability of injury.
Read the detailed description
Computerized dynamic posturography outcomes will be obtained on elite level gymnasts and non gymnasts who will be age matched. The outcome measurement will be obtained using computerized dynamic posturography, a standard diagnostic test of balance function (41-46). The subject's balance was tested using a three-component force platform (CAPS test) under one sensory condition of the modified Clinical Test of Sensory Interaction on Balance (mCTSIB), the eyes closed on perturbing surface condition. This condition was chosen as studies have shown it to be the single test that best correlates with balance impairment and falls. The stability score, already used in several studies by other authors will be used as the primary outcome measure in this research. It is defined as 1 minus the ratio between the measured sway during the test (computed as the major axis of a standard 95% confidence ellipse) and the amount of sway a normal subject of the same height as the one being tested should be able to sway before falling (also known as the theoretical maximum sway or the theoretical limit of stability, calculated using a regression formula based on the subject's height developed by NASA in 1962 and commonly used in all posturographic tests). For convenience, the stability score will be expressed as a percentage. Its definition makes it a convenient and easy to understand measure to use as a subject able to stand perfectly still with no sway will have a score of 100%, whereas one that sways as much as the limit of stability will have a score of 0%. During each test, the subject's sway will be determined by the force platform and its related software. The CAPS three-component force platform uses 3 load cells arranged in a triangle to measure the distribution of the vertical ground reaction force on the platform. The analog load cell signals are amplified and simultaneously sampled by the platform electronics using three synchronized individual 24bit delta-sigma analog to digital converters sampling at 312kHz and decimating the samples to a data rate of 64Hz. The use of three A/D converters insures that the signals from the 3 load cells are acquired simultaneously with no timing error. The high sampling rate with the high decimation and low data rate of the sigma-delta converters eliminates aliasing and provides a resolution of about 4 parts per million. The digital load cell data was then sent via a USB connection to the PC where software uses a calibration matrix determined by the manufacturer to compute the total vertical force and the two horizontal moments acting on the platform. From these data, the software computed the point of application of the vertical force acting on the platform, commonly referred to as the Center of Pressure (CoP). The location of the CoP coincides in static conditions with the projection of the subject's Center of Mass (CoM) onto the platform, and its movement relates to the movements of the subject's CoM (sway). The determination of the actual sway will require the determination of the instantaneous location of the CoM via the location and inertial properties of each body segment of the specific subject being tested. The CAPS test, like all posturographic equipment, uses the movement of the CoP as an approximation of the sway. Because it is an approximation, and because for kinetic reasons the CoP moves more than the CoM, the 95% confidence interval of the CoP motion was considered. This will allow the CAPS software to compute the ellipse that represents the location of all of the sway samples collected during the test with 95% confidence. The major axis of this ellipse will represent the maximum sway of the subject in any direction during the test and it will be used to compute the stability score. To assess the accuracy and resolution of the measurement chain, calibrated weights of 75kg and 100kg will be positioned in the center of the force platform (as if it were a subject) and 20s acquisitions will be performed: the accuracy of the weight must be within the instrument's factory specifications (+-2N). Therefore the accuracy for the position claimed by the manufacturer of +-1mm for a weight of 75kg will be accepted as correct as it determination will require specialized equipment and software available only to the manufacturer. It should be noted that the overall accuracy of the position of the CoP given by the instrument will not be relevant in this study as the motion of the CoP determined the sway. The sway measurement error will be estimated considering the fact that during the test at both weights the dead weight must not move, but the measurement chain will indicate a "sway" of less then 0.05mm (measurement noise), therefore the resolution of the measurement chain and the sway measurement error will be considered to be 0.05mm. To verify the repeatability of the measurement chain, the same type of tests will be repeated two times, obtaining similar results (within the specified accuracy and resolution). Given the sway measurement error, the measurement error in the stability score will be determined. From the definition of the stability score it is clear that the least the theoretical limit of stability, the more pronounced the effect of the sway measurement error is. As the theoretical limit of stability is computed by using the formula 0.55*height*2*sin(6.25°), the shorter the subject, the more the stability score is sensitive to the measurement errors. To estimate the stability score measurement error a subject's height of 1.6m will be considered. Such a subject will have a theoretical limit of stability of 191.6mm. For such a subject, a sway measurement error of 0.05mm means a stability score measurement error of 0.05/191.6 or, if the score is expressed in percentage, of 0.026%. Thus, any changes in the stability score greater than that will be a consequence of the subject's sway and not of measurement errors. A CAPS dynamic posturography test in the eyes closed perturbed stance will be obtained on all subjects. Subjects will be instructed that they will stand on a foam platform and close their eyes while data will be obtained from a computerized force plate. The subjects will be given practice sessions so that they will be familiar with the test prior to the collection of data. The CAPS test occurs over 25 seconds. We will divide the degree of sway observed during the first half of the test and the second half of the test and will obtain ratios. Subjects whose sway will increase in the second half of the test in reference to the first half will be identified as demonstrating a fatigability ratio. Individuals who will demonstrate less sway in the second half of the test will be identified as demonstrating an adaptability ratio that we consider might be related to some type of motor learning. All gymnasts will be instructed in a novel gymnastic routine which will include a variety of inverted postures and ground routines unfamiliar to the subjects. The athletes will be allowed to practice the routine for one hour after which they will be asked to perform the routine in front of the same judge who will be blinded as to the outcome measures previously obtained. The performance scores will be then compared to the CDP measurements to ascertain if there would be any relationship.
- Being tested
- Gymnastic Routine
- Keywords
- Gymnastics, Computerized Dynamic Posturography, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gymnastic RoutineProcedure or surgery
A combination of gymnastic movements are performed
| Study group | Role | What they receive |
|---|---|---|
| Gymnastics | Experimental | Gymnasts stand on a computerized dynamic posturography Force Plate and Stability is measured and gymnastic routines performed Receives: Procedure: Gymnastic Routine |
| Non Gymnasts | Experimental | Non Gymnasts stand on a computerized dynamic posturography Force Plate and Stability is measured and gymnastic routines performed Receives: Procedure: Gymnastic Routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Posturography
stability testing pre and post gymnastic routines
Measured: pre and post
Secondary outcomes (1)
Blinded expert judging of motor performance in Gymnastics
Judging of gymnastic performance
Measured: pre and post immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startJun 2005
- Primary completionJul 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gymnastics Injury, Motor Learning, BalanceStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
- Investigators
- Frederick R Carrick, PhD, FACCN, Study chair, Carrick Institute for Graduate StudiesGuido Pagnacco, PhD, Principal investigator, Carrick Institute for Graduate StudiesElena Oggero, PhD, Principal investigator, Carrick Institute for Graduate StudiesBrandon Brock, DC, Study chair, Carrick Institute for Graduate StudiesTina Arikan, DC, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374569
- Sponsor's protocol ID
- CI-05-05
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2006
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Carrick FR, Oggero E, Pagnacco G, Brock JB, Arikan T. Posturographic testing and motor learning predictability in gymnasts. Disabil Rehabil. 2007 Dec 30;29(24):1881-9. doi: 10.1080/09638280601141335. Epub 2007 Feb 9.
PubMed 17852265
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Posturographic Testing and Motor Learning Predictability in Gymnasts
- ClinicalTrials.gov ID
- NCT00374569
- Acronym / sponsor ID
- CI-05-05
- Keywords
- Gymnastics, Computerized Dynamic Posturography, Balance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 11 Sep 2006 (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.
One aim of this study was to find if there was a difference between balance and stability between elite level gymnasts and non-gymnasts. Another aim was to find if there was a relationship between dynamic posturographic scores associated with sway fatigue or adaptability and the ability to learn new gymnastic routines. The ultimate aim of the study was to improve gymnastic performance while reducing the probability of injury.
Detailed description
Computerized dynamic posturography outcomes will be obtained on elite level gymnasts and non gymnasts who will be age matched. The outcome measurement will be obtained using computerized dynamic posturography, a standard diagnostic test of balance function (41-46). The subject's balance was tested using a three-component force platform (CAPS test) under one sensory condition of the modified Clinical Test of Sensory Interaction on Balance (mCTSIB), the eyes closed on perturbing surface condition. This condition was chosen as studies have shown it to be the single test that best correlates with balance impairment and falls. The stability score, already used in several studies by other authors will be used as the primary outcome measure in this research. It is defined as 1 minus the ratio between the measured sway during the test (computed as the major axis of a standard 95% confidence ellipse) and the amount of sway a normal subject of the same height as the one being tested should be able to sway before falling (also known as the theoretical maximum sway or the theoretical limit of stability, calculated using a regression formula based on the subject's height developed by NASA in 1962 and commonly used in all posturographic tests). For convenience, the stability score will be expressed as a percentage. Its definition makes it a convenient and easy to understand measure to use as a subject able to stand perfectly still with no sway will have a score of 100%, whereas one that sways as much as the limit of stability will have a score of 0%. During each test, the subject's sway will be determined by the force platform and its related software. The CAPS three-component force platform uses 3 load cells arranged in a triangle to measure the distribution of the vertical ground reaction force on the platform. The analog load cell signals are amplified and simultaneously sampled by the platform electronics using three synchronized individual 24bit delta-sigma analog to digital converters sampling at 312kHz and decimating the samples to a data rate of 64Hz. The use of three A/D converters insures that the signals from the 3 load cells are acquired simultaneously with no timing error. The high sampling rate with the high decimation and low data rate of the sigma-delta converters eliminates aliasing and provides a resolution of about 4 parts per million. The digital load cell data was then sent via a USB connection to the PC where software uses a calibration matrix determined by the manufacturer to compute the total vertical force and the two horizontal moments acting on the platform. From these data, the software computed the point of application of the vertical force acting on the platform, commonly referred to as the Center of Pressure (CoP). The location of the CoP coincides in static conditions with the projection of the subject's Center of Mass (CoM) onto the platform, and its movement relates to the movements of the subject's CoM (sway). The determination of the actual sway will require the determination of the instantaneous location of the CoM via the location and inertial properties of each body segment of the specific subject being tested. The CAPS test, like all posturographic equipment, uses the movement of the CoP as an approximation of the sway. Because it is an approximation, and because for kinetic reasons the CoP moves more than the CoM, the 95% confidence interval of the CoP motion was considered. This will allow the CAPS software to compute the ellipse that represents the location of all of the sway samples collected during the test with 95% confidence. The major axis of this ellipse will represent the maximum sway of the subject in any direction during the test and it will be used to compute the stability score. To assess the accuracy and resolution of the measurement chain, calibrated weights of 75kg and 100kg will be positioned in the center of the force platform (as if it were a subject) and 20s acquisitions will be performed: the accuracy of the weight must be within the instrument's factory specifications (+-2N). Therefore the accuracy for the position claimed by the manufacturer of +-1mm for a weight of 75kg will be accepted as correct as it determination will require specialized equipment and software available only to the manufacturer. It should be noted that the overall accuracy of the position of the CoP given by the instrument will not be relevant in this study as the motion of the CoP determined the sway. The sway measurement error will be estimated considering the fact that during the test at both weights the dead weight must not move, but the measurement chain will indicate a "sway" of less then 0.05mm (measurement noise), therefore the resolution of the measurement chain and the sway measurement error will be considered to be 0.05mm. To verify the repeatability of the measurement chain, the same type of tests will be repeated two times, obtaining similar results (within the specified accuracy and resolution). Given the sway measurement error, the measurement error in the stability score will be determined. From the definition of the stability score it is clear that the least the theoretical limit of stability, the more pronounced the effect of the sway measurement error is. As the theoretical limit of stability is computed by using the formula 0.55*height*2*sin(6.25°), the shorter the subject, the more the stability score is sensitive to the measurement errors. To estimate the stability score measurement error a subject's height of 1.6m will be considered. Such a subject will have a theoretical limit of stability of 191.6mm. For such a subject, a sway measurement error of 0.05mm means a stability score measurement error of 0.05/191.6 or, if the score is expressed in percentage, of 0.026%. Thus, any changes in the stability score greater than that will be a consequence of the subject's sway and not of measurement errors. A CAPS dynamic posturography test in the eyes closed perturbed stance will be obtained on all subjects. Subjects will be instructed that they will stand on a foam platform and close their eyes while data will be obtained from a computerized force plate. The subjects will be given practice sessions so that they will be familiar with the test prior to the collection of data. The CAPS test occurs over 25 seconds. We will divide the degree of sway observed during the first half of the test and the second half of the test and will obtain ratios. Subjects whose sway will increase in the second half of the test in reference to the first half will be identified as demonstrating a fatigability ratio. Individuals who will demonstrate less sway in the second half of the test will be identified as demonstrating an adaptability ratio that we consider might be related to some type of motor learning. All gymnasts will be instructed in a novel gymnastic routine which will include a variety of inverted postures and ground routines unfamiliar to the subjects. The athletes will be allowed to practice the routine for one hour after which they will be asked to perform the routine in front of the same judge who will be blinded as to the outcome measures previously obtained. The performance scores will be then compared to the CDP measurements to ascertain if there would be any relationship.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gymnastics | Experimental | Procedure: Gymnastic RoutineGymnasts stand on a computerized dynamic posturography Force Plate and Stability is measured and gymnastic routines performed |
| Non Gymnasts | Experimental | Procedure: Gymnastic RoutineNon Gymnasts stand on a computerized dynamic posturography Force Plate and Stability is measured and gymnastic routines performed |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Elite level Gymnasts
- Non Gymasts control
Key exclusion criteria (1 listed)
- Non Elite level Gymnasts
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 |
|---|---|---|
| Gymnastic RoutineA combination of gymnastic movements are performed | Procedure or surgery | Gymnastics, Non Gymnasts |
Primary outcome
Dynamic Posturography
Time frame: pre and post
stability testing pre and post gymnastic routines
1 secondary outcome
Blinded expert judging of motor performance in Gymnastics
Time frame: pre and post immediate
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 2016.
- Background: PubMed 17852265Carrick FR, Oggero E, Pagnacco G, Brock JB, Arikan T. Posturographic testing and motor learning predictability in gymnasts. Disabil Rehabil. 2007 Dec 30;29(24):1881-9. doi: 10.1080/09638280601141335. Epub 2007 Feb 9.
- 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.
Frederick R Carrick, PhD, FACCN study chair
Carrick Institute for Graduate Studies
Guido Pagnacco, PhD principal investigator
Carrick Institute for Graduate Studies
Elena Oggero, PhD principal investigator
Carrick Institute for Graduate Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gymnastic Routine in people with Gymnastics Injury, Motor Learning, Balance, run by Carrick Institute for Graduate Studies at 1 site in United States.
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 1 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 2016. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Dynamic Posturography (time frame: pre and post). 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 NCT00374569, which also lists 1 linked publication.
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 2016.