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Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function

NCT06261645 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Shoulder Dislocation or Subluxation

Interventions

OTHER

Early Physiotherapist selected active exercises

Exercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance. Education on shoulder muscles functional anatomy and on effect of pain on muscle performance

OTHER

Delayed Physiotherapist selected active exercises

Exercises to restore total rotator cuff function selected and progressed according to patients performance. Performance is assessed by the physiotherapist regarding available range of motion, comfort during as well as pain-free performance. Education on shoulder muscles functional anatomy and on effect of pain on muscle performance

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Monika Fagevik Olsén, Professor · Sahlgrenska Academy, Inst Neuroscience and Physiology/Physiotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261645 on ClinicalTrials.gov