Translation and Validation of the SIRSI and TSK-SI Into German
NCT Number: NCT06555991
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Shoulder Instability
Interventions: OTHER: SIRSI and TSK-SI
Sponsor: Schulthess Klinik
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 135
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-08
Locations: Schulthess Klinik, Zürich, 8008, Switzerland

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.

Primary Outcome Measures: Shoulder Instability Return to Sports Index - German (SIRSI-D), The SIRSI has been adapted to the shoulder instability cohort from the Anterior Cruciate Ligament Return to Sport Index (ACL-RSI) by (Gerometta et al., 2018). It is composed of twelve items that are rated on a zero to ten. The single total score is calculated by multiplying the sum of each item and dividing it by 120. The worst score then is zero indicating no psychological readiness to RTS and 100 the best, indicating full psychological readiness to RTS., Baseline and after one week|Tampa Scale for Kinesiophobia Shoulder Instability German (TSK-SI-D), The TSK-SI has been adapted to the shoulder cohort by van Iersel et al (2023). The TSK-SI is composed of 18 questions scored on a 4 point Likert-Scale from "Strongly agree" to "Strongly disagree". The lowest score is 18, indicating no kinesiophobia and 72, indicating highest level of kinesiophobia., Baseline and after one week
Secondary Outcome Measures: Western Ontario Shoulderinstability Index German (WOSI), The the Western Ontario Shoulderinstability Index (WOSI) was developed by Kirkley (2003) and is the most prominent PROM in clinic and research for shoulder instability. The WOSI consists of 21 items and four domains: Physical symptoms (10 items), Sports, recreation, and work (4 items), lifestyle (4 items) and emotions (3 items). The scale for each item ranges from 0 to 100, allowing for a total score of 0 (best) to 2100 (worst)., Baseline|SSV and sSSV, The subjective shoulder value (SSV) was introduced by Gilbart and Gerber (2007) and provides a simple measure to represent shoulder functionality during activities of daily living (ADL). Patients are asked to rate their overall shoulder state on a scale from 0 to 100 percent, where a healthy shoulder is 100 percent. Because the standard SSV might lack sport specific context Descamps et al (2023) suggested the sport subjective shoulder value (sSSV) with the question "Regarding sports practice, what is the overall percent value of your shoulder, if a completely normal shoulder represents 100% and a non-functional shoulder represents 0%?". Both scales result in a value between zero and 100, where zero means no subjective functionality during ADL or Sport respectively., Baseline|Return to Sports Status, Ardern et al (2016) defined RTS as that the athlete has returned to his previous sport but not necessarily at the same performance level and differentiated it to return to participation and return to performance. This spectrum will be assessed using custom build questions to determine the RTS level, Baseline