Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

Prosthesis User Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357143
• Other study ID #: REMOVE
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 three times, at baseline, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults with a reverse shoulder prosthesis.
• Age between 18 and 75 years.
• Signed informed consent.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Prosthesis User
• Shoulder Fractures

Intervention

Other:
• REMOVE
Early multimodal physiotherapy program focused on therapeutic exercise
• CONTROL
Standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functionality	American Shoulder and Elbow Surgeons Scale (ASES)	BASELINE, 12 WEEKS, 24 WEEKS
Secondary	Muscle mass	Ultrasound image	BASELINE, 12 WEEKS, 24 WEEKS
Secondary	Kinematics	Inertial sensors	BASELINE, 12 WEEKS, 24 WEEKS
Secondary	Strength	Dynamometer	BASELINE, 12 WEEKS, 24 WEEKS
Secondary	Range of movement	Goniometer	BASELINE, 12 WEEKS, 24 WEEKS