Anterior Shoulder Dislocation Clinical Trial
Official title:
Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability
Verified date | November 2019 |
Source | Western Norway University of Applied Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be
identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed
for patients with TASI, but has not yet been tested in patients eligible for surgery. The
purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX
program for patients diagnosed with TASI and eligible for surgery.
A feasibility study with an experimental, longitudinal design using both quantitative and
qualitative research methods. Participants undergo the SINEX program, a twelve week exercise
program including physiotherapist supervised sessions. Feasibility data on recruitment,
retention, compliance, acceptability and safety was collected through observation and
individual semi-structured interviews. Clinical tests and self-report questionnaires were
completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and
relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control
measured by center of pressure path length (COPL) on a force platform, isometric strength
measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC), self-report
questionnaires included Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of
Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE).
Status | Completed |
Enrollment | 7 |
Est. completion date | August 31, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery Exclusion Criteria: - complex shoulder injuries not suitable for a Bankart procedure as determined by an orthopedic surgeon, insufficient Norwegian language skills, and/or not being able to participate in a supervised exercise program |
Country | Name | City | State |
---|---|---|---|
Norway | Bergen University College | Bergen |
Lead Sponsor | Collaborator |
---|---|
Western Norway University of Applied Sciences |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ontario Shoulder Instability Index (WOSI) | change in shoulder quality of life | Baseline, 12 weeks | |
Secondary | Tampa Scale of Kinesiophobia (TSK) | Change in fear of movement and re-injury, numbers | Baseline, 12 weeks | |
Secondary | Sensorimotor control measured by center of pressure path length (COPL) | Change in shoulder stability, mm | Baseline, 12 weeks | |
Secondary | Shoulder joint position sense (SJPS) | Change in shoulder position stability, degrees | Baseline, 12 weeks | |
Secondary | Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC) | Change in muscle strength, kg | Baseline, 12 weeks | |
Secondary | Apprehension and relocation tests | Change in anterior glenohumeral instability, positive/negative | Baseline, 12 weeks | |
Secondary | Global Perceived Effect questionnaire (GPE) | Impression of change, 1-7 | at 12 weeks |
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