Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555991
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Translation and Validation of the SIRSI and TSK-SI Into German
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Translation and Validation of the Shoulder Instability Return to Sports Index SIRSI and Tampa Scale of Kinesiophobia Shoulder Instability TSK-SI Into German
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clinicians need to evaluate the psychological readiness to return to sports after an shoulder injury The SIRSI is a questionnaire that provides such information however it has not yet been translated and tested for a German speaking population Switzerland Austria or Germany Similarily the TSK-SI is a questionnaire that measures fear of movement in patients with shoulderinstability which is also not available to German speaking patients
We conduct this study to translate both questionnaires into German and test it in German speaking patients in Switzerland
We conduct this study to translate both questionnaires into German and test it in German speaking patients in Switzerland
Detailed Description:
Return to Sports RTS is an important outcome measure after shoulder instability treatment Abdul-Rassoul et al 2019 While the definition of returning to sport is not clear Doege et al 2021 efforts have been made to provide consensus The concept of Return to Sport is multifactorial consisting of physical psychological and socialcontextual factors in an interplay with sociodemographic and injury factors Furthermore different stages of RTS have been defined Ardern et al 2016 To take all factors into account outcome measures like the ACL-RSI for anterior cruciate ligament ruptures have been invented Webster et al 2008 To provide such a measure for the shoulder instability cohort Gerometta et al 2018 have adapted the ACL-RSI to a shoulder instability population and named it the Shoulder Instability Return to Sport Index SIRSI Since then this outcome has been frequently used to determine psychological readiness to RTS Rossi et al 2022 Despite an available German translation published by a German insurance company Return-to-Competition Schulter Shoulder Instability-Return to Sport after Injury SIRSI-Skala vbgde accessed 23012024 the SIRSI is not scientifically available for a German speaking population because this version has never been officially translated and validated Similarly the Tampa Scale for Kinesiophobia TSK has been invented to measure an excessive fear of movement due to painful injury in chronic low back pain Miller et al 1991 The Scale was then adapted to the shoulder instability cohort van Iersel et al 2023 However it is currently not available in German Therefore this project seeks to translate the SIRSI and TSK-SI into a German version and validate them in a German speaking population in Switzerland
The aim of the project is to translate the Shoulder Instability Return to Sports Index SIRSI and Tampa Scale for Kinesiophobia - Shoulder Instability TSK-SI into a German version and assess its validity in a Swiss-German population of patients with shoulder instability treated conservatively or surgically and planning to return to sports
The aim of the project is to translate the Shoulder Instability Return to Sports Index SIRSI and Tampa Scale for Kinesiophobia - Shoulder Instability TSK-SI into a German version and assess its validity in a Swiss-German population of patients with shoulder instability treated conservatively or surgically and planning to return to sports
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None