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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05777096
Other study ID # 2023-A00131-44
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2023
Est. completion date August 4, 2023

Study information

Verified date March 2024
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective is to determine the prevalence of non-traumatic pathologies in the paragliding population using the Nordic type questionnaire. The paragliding pilots population frequently evoque pathologies, discomfort, or pain in the course of their practice. Said pain and discomfort, though unerelated any form of accident, seem to have an impact on the pilots' flying and their participation in daily life. However, no epidemiological data are available in the literature. Investigators hypothesize the existence of non-traumatic disorders and it seems interesting to quantify the extent of the phenomenon. The results of this study might encourage the proposition of preventive measures in order to minimize a potential risk factor for paragliding accidents, and participation restrictions.


Description:

In this cross-sectional descriptive epidemiological survey, investigators wish to quantify epidemiological parameters such as the prevalence of pathologies and their consequences in the activities of daily life. For this purpose, an email containing the link to answer the online questionnaire will be sent to all the licensees. The link of the questionnaire will be sent directly to all clubs in each league. The main objective is to calculate the prevalence with descriptive statistics. The primary outcome is the prevalence of non-traumatic pathology in paragliding pilots that had registered to the French Paragliding federation (FFVL) in 2022. The prevalence will be infered from the IRSST Standardised Nordic Questionnaire with the following formula : Prevalence = (FS4+FS6=yes and FS2=no ) divided by the total number of respondents. FS4 item "Yes" = pain in the last 12 months FS6 item "Yes" = activity limitations) FS2 item "No" = Non-traumatic disorders This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having suffered trauma in the area. For the secondary outcomes will aim at exploring several hypotheses related to personal and environmental factors that could be correlated to the incidence of the nontraumatic disorders. They will be calculated with bivariate descriptive statistics using the Pvalue.io software.


Recruitment information / eligibility

Status Completed
Enrollment 2475
Est. completion date August 4, 2023
Est. primary completion date June 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - over 18 years old - Registered with the FFVL for the year 2022 and/or 2023 - Paragliding in the year 2022 and/or 2023 Exclusion Criteria: - Adults not able to express their consent

Study Design


Intervention

Diagnostic Test:
Standardised Nordic questionnaires
participants will complete the SNQ online. Estimated time of participation per person: 15 minutes to fill in the questionnaires

Locations

Country Name City State
France Grenoble Alpes University - Faculty of Medecine - Departement of Physiotherapy Saint-Martin-d'Hères

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (3)

Alexis Descatha, Yves Roquelaure, Agnès Aublet-Cuvelier, Catherine Ha, Annie Touranchet, et al.. Validité du questionnaire de type "Nordique" dans la surveillance des pathologies d'hypersollicitation du membre supérieur. Documents pour le Médecin du Travail, 2007, pp.509-517. ffinserm-00232629

desLibris, L'enque^te que´be´coise sur la sante´ de la population 2008, Canadian Electronic Library. Canada. Retrieved from https://canadacommons.ca/artifacts/1238967/lenquete-quebecoise-sur-la-sante-de-la-population-2008/1792039/ on 05 Mar 2023. CID: 20.500.12592/rvf74g.

Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of non-traumatic pathologies in the paragliding pilot population The prevalence will be calculated using the IRSST's Standardised Nordic Questionnaire.
Prevalence = (FS4+FS6=yes and FS2=no ) on total number of respondents. This prevalence will be calculated on the Population Health, with the FS4 and FS6 items. And to be more specific about atraumatic pathologies, it is necessary to have answered "no" to the FS2 item. This corresponds to having felt pain in the body region indicated, at least once during the last 12 months, as well as a restriction of participation following this pain, but without having undergone trauma in the area concerned.
Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Secondary Correlations between prevalence, a body area, restriction of participation in paragliding and individual characteristics of participants Correlation analysis (univariate and bivariate) between responses to different questions to test for a potential association between variables Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Secondary Paragliders' beliefs about the origin of their pain. Number of respondents with musculoskeletal disorder (FS9=yes)/total number of positive cases ((FS4+FS6=yes and FS2=no) Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
Secondary Prevalence of injuries sustained during a paragliding accident Number of respondents with musculoskeletal disorder due to accident/total number of pain positive cases and participation restriction ((FS4+FS6=yes and FS2.3=yes) Cross sectional study. Each participant is evaluated for 15 minutes (estimated time of completion of the questionnaire)
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