Actively Recruiting

Phase Not Applicable
Age: 16Years - 35Years
All Genders
NCT06261645

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

Led by Sahlgrenska University Hospital · Updated on 2024-03-08

100

Participants Needed

1

Research Sites

187 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 16Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Young adults aged 16 to 35 with non-traumatic, non-controllable, positional, functional shoulder instability showing at least 20% lack of active dynamic control compared to passive shoulder rotation range
  • Ability to understand Swedish well in speaking, reading, and writing
Not Eligible

You will not qualify if you...

  • Presence of other significant shoulder problems or diagnosis of severe systemic connective tissue disorders, congenital abnormalities, or psychiatric conditions
  • Less than 60% adherence to assigned exercise program

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sahlgrenska University Hospital/Mölndal, Physiotherapy Dpt

Gothenburg, Mölndal, Sweden, SE 43180

Actively Recruiting

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Research Team

I

Ingrid K Hultenheim Klinberg, PhD

CONTACT

E

Emil Steen, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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