Clinical trial NCT06357143: Efficacy of Early Multimodal Physiotherapy in Patients with Reverse Shoulder Prosthesis
Official title: Efficacy of Early Multimodal Physiotherapy in Patients with Reverse Shoulder Prosthesis: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Fractures
Prosthesis User
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.

Detailed description: Background: Shoulder fractures, shoulder osteoarthritis and rheumatoid arthritis have a high prevalence and many times they require a surgery, in which a reverse shoulder phrostesis is colocated. Nonetheless, nowadays there is no a clear consensus protocol in order to manage the prehabilitation and rehabilitation of this patient, so each physiotherapist use different techniques to treat this pathology.

Objective: This study aims to evaluate the effectiveness of an original intervention program (REMOVE program) focused on an early intervention based on therapeutic exercise, manual therapy and education to improve the functionality of these patients after surgery.

Methods: This study is a randomized controlled trial with parallel groups. The control group receive standard care, and the experimental group is subjected to the REMOVE program. Both groups are evaluated five times, pre-surgery, at baseline, at 6 weeks, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.

Eligibility criteria: Inclusion Criteria:

* Adults with a reverse shoulder prosthesis.
* Age between 18 and 90 years.
* Signed informed consent.

Exclusion Criteria:

* Language or cultural barriers.
* Other upper limb injury.
* Treatment that affect physical activity capacity.

Primary outcomes:
measure: American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
Secondary outcomes:
measure: Ultrasound image - Muscle thickness in centimeters.
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: Inertial sensors - Linear acceleration and angular velocity
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: Dynamometer - Strength in Newtons.
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: Goniometer - Range of motion in degrees.
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: Constant-Murley Score (CS) - Functionality
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: University of California - Los Angeles Shoulder Scale (UCLA) - Functionality.
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: Simple Shoulder Test (SST) - Functionality.
timeFrame: BASELINE, 12 WEEKS, 24 WEEKS
measure: Physiological fatigue - high density electromyography
timeFrame: Baseline, 6 Weeks, 12 weeks, 24 weeks.
measure: Kinematics - Motion capture system
timeFrame: Baseline, 6 weeks, 12 weeks, 24 weeks.
Other outcomes:
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