Bergen University College
Bergen, 5020, Norway
NCT Number: NCT04152304
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).
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Notify Me16 year–45 year
All sexes
Interventional
Not applicable
Bergen, 5020, Norway
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder
Time frame: Baseline, 12 weeks
change in shoulder quality of life
Time frame: Baseline, 12 weeks
Change in fear of movement and re-injury, numbers
Time frame: Baseline, 12 weeks
Change in shoulder stability, mm
Time frame: Baseline, 12 weeks
Change in shoulder position stability, degrees
Time frame: Baseline, 12 weeks
Change in muscle strength, kg
Time frame: Baseline, 12 weeks
Change in anterior glenohumeral instability, positive/negative
Time frame: at 12 weeks
Impression of change, 1-7
Western Norway University of Applied Sciences
Other
Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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