Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

NCT06357143 | Recruiting DMC

• 1 other identifier: REMOVE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Fractures; Prosthesis User

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.

  This tool is used to evaluate functionality and shoulder-related problems. This scale contains demographic data, medical evaluation, and self-reported outcomes, with a visual analog scale (VAS) to report pain, and 10 items regarding daily life activities. The score is calculated: \[(10 - score obtained in VAS) x 5\] + (5/3 x score obtained in daily life activities)\]. The worst result is 0 points and the best one is 100 points.

  BASELINE, 12 WEEKS, 24 WEEKS

Secondary Outcomes (9)

• Ultrasound image - Muscle thickness in centimeters.

  BASELINE, 12 WEEKS, 24 WEEKS

• Inertial sensors - Linear acceleration and angular velocity

  BASELINE, 12 WEEKS, 24 WEEKS

• Dynamometer - Strength in Newtons.

  BASELINE, 12 WEEKS, 24 WEEKS

• Goniometer - Range of motion in degrees.

  BASELINE, 12 WEEKS, 24 WEEKS

• Constant-Murley Score (CS) - Functionality

  BASELINE, 12 WEEKS, 24 WEEKS

Study Arms (2)

CONTROL GROUP - STANDARD PHYSIOTHERAPY

ACTIVE COMPARATOR

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

Other: CONTROL

EXPERIMENTAL GROUP - REMOVE PROGRAM

EXPERIMENTAL

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

Other: REMOVE

Interventions

REMOVE 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

EXPERIMENTAL GROUP - REMOVE PROGRAM

CONTROL 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

CONTROL GROUP - STANDARD PHYSIOTHERAPY

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Antonio Cuesta Vargas

Málaga, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Central Study Contacts

Antonio I Cuesta-Vargas, PhD

CONTACT

(+34) 667 45 55 44; acuesta@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)