Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Malaga
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with a reverse shoulder prosthesis.
Age between 18 and 90 years.
Signed informed consent.
Disqualifiers
Language or cultural barriers.
Other upper limb injury.
Treatment that affect physical activity capacity.
Trial design
Design model
Parallel
Treatments tested in this trial
REMOVE
Other interventionINITIAL 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
CONTROL
Other interventionPatients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CONTROL GROUP - STANDARD PHYSIOTHERAPYActive comparator 1 intervention
Group B: EXPERIMENTAL GROUP - REMOVE PROGRAMExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
BASELINE, 12 WEEKS, 24 WEEKSSecondary outcomes
1
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.
Time frame
BASELINE, 12 WEEKS, 24 WEEKS2
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.
Time frame
BASELINE, 12 WEEKS, 24 WEEKS3
Dynamometer - Strength in Newtons.
To measure strength, time to peak, rate of force development, and muscle power of the lateral deltoid.
Time frame
BASELINE, 12 WEEKS, 24 WEEKS4
Goniometer - Range of motion in degrees.
To measure the range of motion, both passive and active, in flexion, abduction, external rotation and internal rotation.
Time frame
BASELINE, 12 WEEKS, 24 WEEKSSponsors and contacts
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Source ClinicalTrials.gov