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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02904044
Other study ID # 2011/CHU/TsColEPS
Secondary ID
Status Completed
Phase N/A
First received September 8, 2016
Last updated September 13, 2016
Start date September 2012
Est. completion date June 2015

Study information

Verified date September 2016
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertésFrance: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.


Description:

Sport injuries during physical activities lessons are the first etiology of traumatism in secondary school. Epidemiological studies on individual determinants of sport injuries are very scarce and most focused on contextual or mixed determinants.

TsColEPS is a multicenter case control study with one control paired to one case.

A convenience sample of 500 pupils in each group was planned on the base of a range of expected odds ratios.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date June 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- in secondary public school classroom in south of Reunion Island

- no age limited

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Universitaire Saint Pierre île de La Réunion

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual determinants of sport injuries during physical activity lessons in secondary school measured by a series of questionnaires at school (nurse interview), at home (family interview) and at the doctor's office for diagnosis Questionnaires are compiled in the CRC for datamanagement and analysis. Determinants are computed in frequency and proportion or mean +/- SD and analysed in a multilevel model 2 years with 1 year follow-up No
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