NCT06261645 Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function
| NCT ID | NCT06261645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Shoulder Dislocation or Subluxation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-05-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * young adults, non traumatic as well as non-controllable, positional, functional shoulder instability according to Moroder et al. demonstrating a lack of ≥ 20%, active, dynamic control compared with the total passive range of motion in shoulder rotation with or without previous shoulder stabilizing surgery * Understanding the Swedish language well, in speaking, in reading and writing. Exclusion Criteria: * Other significant shoulder pathologies, patients diagnosed with severe systemic connective tissue, congenital anatomic abnormalities, or psychiatric diagnoses according to previous medical records * \<60% adherence to assigned exercises
Contact & Investigator
Monika Fagevik Olsén, Professor
PRINCIPAL INVESTIGATOR
Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy
Frequently Asked Questions
Who can join the NCT06261645 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Shoulder Dislocation or Subluxation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06261645 currently recruiting?
Yes, NCT06261645 is actively recruiting participants. Contact the research team at ingrid.hultenheim-klintberg@vgregion.se for enrollment information.
Where is the NCT06261645 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT06261645 clinical trial?
NCT06261645 is sponsored by Sahlgrenska University Hospital. The principal investigator is Monika Fagevik Olsén, Professor at Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy. The trial plans to enroll 100 participants.