protocolSection identificationModule nctId: NCT06261645, orgStudyIdInfo id: ROTOFUNK_2_2023, briefTitle: Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function, acronym: ROTOFUNC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sahlgrenska University Hospital, Sweden, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition., conditionsModule conditions: Shoulder Dislocation or Subluxation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A 16 week exercise program with specific exercises to restore total rotator cuff function individually selected during clinical physiotherapy visits and performed 2 - 4 times daily.In addition, the patient will receive education and guidance in the daily use of the arm to adjust to appropriate load on the shoulder., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Investigator: 6 physiotherapists are care providers, responsible for the Intervention . Two independent investigators does not know who is the actual care provider. However, all patients recieve the same intervention.Outcome assessor: each participant is given a research code. The results from the assessments are entered in the data base by a research assistant, not involved in the study on any level.Individuals are not identifiable. The outcome assessor are planning for all statistics used and is not in other ways involved in the study., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Early Physiotherapist selected active exercises, interventions name: Delayed Physiotherapist selected active exercises, outcomesModule primaryOutcomes measure: Neuromuscular control, secondaryOutcomes measure: Clinical assessment - Active and passive range of motion, secondaryOutcomes measure: Pain at rest, secondaryOutcomes measure: Pain during motion, secondaryOutcomes measure: Apprehension of instability during motion, secondaryOutcomes measure: Patient reported quality-of-life in relation to shoulder function, secondaryOutcomes measure: Patient's satisfaction, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt, status: RECRUITING, city: Gothenburg, state: Mölndal, zip: SE 43180, country: Sweden, contacts name: Ingrid K Hultenheim Klintberg, PhD, role: CONTACT, email: ingrid.hultenheim-klintberg@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False