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Recruiting NCT06357143

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

No phase Interventional Shoulder Fractures Prosthesis User

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REMOVE, CONTROL.
Who it may be relevant to
Registry conditions: Shoulder Fractures, Prosthesis User. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis: a Randomized Controlled Trial.

Overview

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.

Interventions

  • Other 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 abdu
  • 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

Primary outcome measures

  • American Shoulder and Elbow Surgeons Scale (ASES) - Functionality. [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
Secondary outcome measures (9)
  • Ultrasound image - Muscle thickness in centimeters. [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • Inertial sensors - Linear acceleration and angular velocity [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • Dynamometer - Strength in Newtons. [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • Goniometer - Range of motion in degrees. [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • Constant-Murley Score (CS) - Functionality [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • University of California - Los Angeles Shoulder Scale (UCLA) - Functionality. [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • Simple Shoulder Test (SST) - Functionality. [Time frame: BASELINE, 12 WEEKS, 24 WEEKS]
  • Physiological fatigue - high density electromyography [Time frame: Baseline, 6 Weeks, 12 weeks, 24 weeks.]
  • Kinematics - Motion capture system [Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Antonio Cuesta Vargas — Málaga

Identifiers

NCT: NCT06357143 · REMOVE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗