Shoulder FracturesNCT06357143
Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis
A study testing REMOVE in people with Shoulder Fractures and Prosthesis User, run by University of Malaga at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shoulder Fractures, Prosthesis User
- What is being tested?
- REMOVE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a reverse shoulder prosthesis.
- Age between 18 and 90 years.
- Signed informed consent.
Who cannot join
- Language or cultural barriers.
- Other upper limb injury.
- Treatment that affect physical activity capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Antonio Cuesta Vargas
Málaga
Antonio Ignacio, Cuesta Vargas, PhD, 952137551 ext. +34, acuesta@uma.es
Cuesta Vargas A Antonio Ignacio, PhD
About this study
Official title: Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis: a Randomized Controlled Trial.
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.
Read the 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
- Being tested
- REMOVE, CONTROL
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMOVEOther
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
CONTROLOther
Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: REMOVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Secondary outcomes (9)
Ultrasound image - Muscle thickness in centimeters.
To measure the thickness of lateral deltoid muscle at rest, at maximum contraction, and fatigued, being able to compare the muscle mass variation between presurgical and postsurgical situation, and the effect of the intervention in this variable.
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Inertial sensors - Linear acceleration and angular velocity
To assess kinematics variables such as angular velocity and linear acceleration during flexion, abduction and scaption, to evaluate the scapulohumeral rhythm and the tridimensional scapula motion.
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Dynamometer - Strength in Newtons.
To measure strength, time to peak, rate of force development, and muscle power of the lateral deltoid.
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Goniometer - Range of motion in degrees.
To measure the range of motion, both passive and active, in flexion, abduction, external rotation and internal rotation.
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Constant-Murley Score (CS) - Functionality
To evaluate functional status of the shoulder. The scale is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points).
The total score is between 0 points (worst result) and 100 points (best result).
Measured: BASELINE, 12 WEEKS, 24 WEEKS
University of California - Los Angeles Shoulder Scale (UCLA) - Functionality.
To assess functional outcomes after shoulder interventions. The scale include five categories: active forward flexion (5 points), strength of forward flexion (5 points), pain (10 points), satisfaction (5 points), and function (10 points).
The total score range from 0 points (worst result) and 35 points (best result).
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Simple Shoulder Test (SST) - Functionality.
To evaluate the ability of the affected shoulder to perform daily live activities.
The tool is based on 12 "yes" (1 point) or "no" (0 points) questions. Overall score is calculated by: [number of "yes" / number of completex items] x 100, were 0 % is the worst result, and 100% is the best result.
Measured: BASELINE, 12 WEEKS, 24 WEEKS
Physiological fatigue - high density electromyography
We are going to use a matrix of 64 electrodes located on middle deltoid muscle. The variables extracted will be: impulse train, motor neuron recruitment,, neural drive speed
Measured: Baseline, 6 Weeks, 12 weeks, 24 weeks.
Kinematics - Motion capture system
We are going to record analytical movements (forward flexion, lateral abduction, scaption) and functional movements with a mobile phone camera, to analyze position, linear acceleration and angular velocity
Measured: Baseline, 6 weeks, 12 weeks, 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357143
- Sponsor's protocol ID
- REMOVE
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06357143
- Acronym / sponsor ID
- REMOVE
- Conditions
- Shoulder Fractures, Prosthesis User
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP - STANDARD PHYSIOTHERAPY | Active comparator | Other: CONTROLPatients 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 | Experimental | Other: REMOVEINITIAL 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with a reverse shoulder prosthesis.
- Age between 18 and 90 years.
- Signed informed consent.
Key exclusion criteria (3 listed)
- Language or cultural barriers.
- Other upper limb injury.
- Treatment that affect physical activity capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMOVEINITIAL 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 | EXPERIMENTAL GROUP - REMOVE PROGRAM |
| CONTROLPatients 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 GROUP - STANDARD PHYSIOTHERAPY |
Primary outcome
American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.
Time frame: BASELINE, 12 WEEKS, 24 WEEKS
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMOVE in people with Shoulder Fractures and Prosthesis User, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio I Cuesta-Vargas, PhD ((+34) 667 45 55 44, acuesta@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons Scale (ASES) - Functionality. (time frame: BASELINE, 12 WEEKS, 24 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.