Translation and Validation of the SIRSI and TSK-SI Into German

NCT06555991 | Completed

• 1 other identifier: OE-236
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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. This study is conducted to translate both questionnaires into German and test it in German speaking patients in Switzerland.

Conditions

Shoulder Instability

Keywords

Return to Sports; Shoulder Instability; SIRSI; TSK-SI; Kinesiophobia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Western Ontario Shoulderinstability Index German (WOSI)

  Baseline

• SSV

  Baseline

• sSSV

  Baseline

• Return to Sports Status

  Baseline

Study Arms (1)

SIRSI and TSK-SI

OTHER

The SIRSI and TSK-SI as well as the WOSI and RTS-, Clinical- and Demographic Information are gathered. The SIRSI and TSK-SI are re-administered one week later

Other: SIRSI and TSK-SI

Interventions

SIRSI and TSK-SI OTHER

The SIRSI and TSK-SI as well as the WOSI and RTS-, Clinical- and Demographic Information are gathered. The SIRSI and TSK-SI are re-administered one week later

SIRSI and TSK-SI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had an instability event within last year
• Provided general consent for local shoulder instability register at Schulthess Klinik Zürich
• Adult patients aged 18 or older

You may not qualify if:

• Are at least three months after surgery or instability event
• Must endeavor to return to their sport
• Have another physical or psychological disorder not related to shoulder instability compromising return to sports
• Have a language barrier to complete the questionnaires in German
• Are legally incapable of participating in research studies

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Related Publications (2)

• van Iersel TP, Larsen van Gastel M, Versantvoort A, Hekman KMC, Sierevelt IN, Broekman BFP, van den Bekerom MPJ; Dutch Shoulder Instability Group (DSIG). The Modified Tampa-Scale of Kinesiophobia for Anterior Shoulder Instability. Arthrosc Sports Med Rehabil. 2023 Jul 24;5(4):100768. doi: 10.1016/j.asmr.2023.100768. eCollection 2023 Aug.

  PMID: 37645388 BACKGROUND

• Gerometta A, Klouche S, Herman S, Lefevre N, Bohu Y. The Shoulder Instability-Return to Sport after Injury (SIRSI): a valid and reproducible scale to quantify psychological readiness to return to sport after traumatic shoulder instability. Knee Surg Sports Traumatol Arthrosc. 2018 Jan;26(1):203-211. doi: 10.1007/s00167-017-4645-0. Epub 2017 Jul 13.

  PMID: 28707114 BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Asimina Lazaridou, PhD

  Schulthess Klinik Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 15, 2024
• Study Start: August 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CH (1)