Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

NCT ID: NCT06357143

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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.

Conditions

Shoulder Fractures; Prosthesis User

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CONTROL GROUP - STANDARD PHYSIOTHERAPY

Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education

Group Type: ACTIVE_COMPARATOR

CONTROL

Intervention Type: OTHER

Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education

EXPERIMENTAL GROUP - REMOVE PROGRAM

INITIAL STAGE:

• Aim: Recover mobility
• Exercises: Passive therapy, isometric exercises focused on middle deltoid.
• Goal: 80º passive flexion, 45º abduction, 5 N of abduction force STRENGTHENING STAGE
• Aim: Enhance scapulohumeral rhythm and strength rotator cura
• Exercises: Active-assisted therapy, isotonic exercises between 45-90º of forward flexión and abduction with dumbbells and isometric exercises focused on internal and external rotation.
• Goal: 100º passive flexion, 90º lateral abduction, 10 N of abduction force INTENSIVE STAGE
• Aim: Improve motor control and increase cross-sectional muscular área
• Exercises: Rowe with resistance band, wall push ups, lateral elevation with dumbbles, active external and internal rotation.
• Goal: 15 N of abduction force FUNCTIONAL STAGE
• Aim: Develope daily life activities
• Exercises: Overhead tasks, rowe with Kettlebell, internal and external rotations with resistance bands
• Goal: 20 N of abduction force

Group Type: EXPERIMENTAL

REMOVE

Intervention Type: OTHER

INITIAL STAGE:

• Aim: Recover mobility
• Exercises: Passive therapy, isometric exercises focused on middle deltoid.
• Goal: 80º passive flexion, 45º abduction, 5 N of abduction force STRENGTHENING STAGE
• Aim: Enhance scapulohumeral rhythm and strength rotator cura
• Exercises: Active-assisted therapy, isotonic exercises between 45-90º of forward flexión and abduction with dumbbells and isometric exercises focused on internal and external rotation.
• Goal: 100º passive flexion, 90º lateral abduction, 10 N of abduction force INTENSIVE STAGE
• Aim: Improve motor control and increase cross-sectional muscular área
• Exercises: Rowe with resistance band, wall push ups, lateral elevation with dumbbles, active external and internal rotation.
• Goal: 15 N of abduction force FUNCTIONAL STAGE
• Aim: Develope daily life activities
• Exercises: Overhead tasks, rowe with Kettlebell, internal and external rotations with resistance bands
• Goal: 20 N of abduction force

Interventions

REMOVE

INITIAL STAGE:

• Aim: Recover mobility
• Exercises: Passive therapy, isometric exercises focused on middle deltoid.
• Goal: 80º passive flexion, 45º abduction, 5 N of abduction force STRENGTHENING STAGE
• Aim: Enhance scapulohumeral rhythm and strength rotator cura
• Exercises: Active-assisted therapy, isotonic exercises between 45-90º of forward flexión and abduction with dumbbells and isometric exercises focused on internal and external rotation.
• Goal: 100º passive flexion, 90º lateral abduction, 10 N of abduction force INTENSIVE STAGE
• Aim: Improve motor control and increase cross-sectional muscular área
• Exercises: Rowe with resistance band, wall push ups, lateral elevation with dumbbles, active external and internal rotation.
• Goal: 15 N of abduction force FUNCTIONAL STAGE
• Aim: Develope daily life activities
• Exercises: Overhead tasks, rowe with Kettlebell, internal and external rotations with resistance bands
• Goal: 20 N of abduction force

Intervention Type: OTHER

CONTROL

Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Antonio I Cuesta-Vargas, PhD

Role: CONTACT

acuesta@uma.es

(+34) 667 45 55 44

Other Identifiers

REMOVE

Identifier Type: -

Identifier Source: org_study_id