Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR) (IODPR)
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ClinicalTrials.gov Identifier: NCT03648125 |
Recruitment Status :
Terminated
(Limited time between the beginning and the end of the inclusions, only 7 high level rowers available within the time compatible with research realization)
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | May 25, 2018 | ||||
First Posted Date ICMJE | August 27, 2018 | ||||
Last Update Posted Date | August 27, 2018 | ||||
Actual Study Start Date ICMJE | October 27, 2017 | ||||
Actual Primary Completion Date | November 22, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Muscular power [ Time Frame: At the time of inclusion ] Muscular power (in Watts) developed by the high level rowers with the "leg press" test on a "Dyno concept 2" machine, with and without artificial occlusal disturbance. Each test lasts 30 seconds. The sequence consists in 2 tests and is performed twice with a resting period of 1 min between each recording.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR) | ||||
Official Title ICMJE | Influence of Dental Occlusion on the Performance of High Level Rowers (IODPR) | ||||
Brief Summary | Monocentric, prospective, randomized, open-label, cross-over study. | ||||
Detailed Description | Current literature data suggest that dental occlusion has an influence on postural control in the general population, and more markedly in high-level athletes. The link between dental occlusion and the postural stability of top athletes has been studied in several disciplines such as basketball, shooting, golf and running. There is currently no data in the field of rowing. But this sport requires optimal postural control for synchronous and symmetrical muscle solicitation. The present study aims to evaluate the influence of dental occlusion on postural stability and the performance of high level rowers. Our assumptions are as follows:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention Model Description: Prospective, monocentric, randomized, open-label, cross-over study. Randomization applies on the order of the training sessions "with" or "without" occlusal disturbance. Masking: None (Open Label)Primary Purpose: Basic Science |
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Condition ICMJE | Dental Occlusion, Traumatic | ||||
Intervention ICMJE |
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Study Arms ICMJE | Rowing training session
Power tests, balance and tonicity tests are performed eyes opened and eyes closed :
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
7 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 22, 2017 | ||||
Actual Primary Completion Date | November 22, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03648125 | ||||
Other Study ID Numbers ICMJE | 35RC17_8823_IODPR | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Rennes University Hospital | ||||
Study Sponsor ICMJE | Rennes University Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Rennes University Hospital | ||||
Verification Date | August 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |