Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06357143

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

Led by University of Malaga · Updated on 2026-04-08

40

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how effective an early intervention program based on multimodal physiotherapy and therapeutic exercise is for patients who have received a reverse shoulder prosthesis. The study addresses the lack of a clear, standardized rehabilitation protocol for these patients and seeks to develop new treatment guidelines that improve their recovery and shoulder function. It is a randomized controlled trial comparing a new program called the REMOVE program with standard care. Participants are divided into two groups: one receiving standard care, which includes an initial physiotherapy consultation with exercise recommendations and health education; the other undergoing the REMOVE program. The REMOVE program involves four stages: an initial stage focusing on recovering mobility with passive therapy and isometric exercises; a strengthening stage with active-assisted and isotonic exercises; an intensive stage to improve motor control and muscle area using resistance bands and weights; and a functional stage designed to develop daily living activities with specific exercises and resistance training. Throughout the study, participants are assessed five times: before surgery, at baseline, and then at 6, 12, and 24 weeks after surgery. Measurements include psychometric questionnaires and laboratory tests such as muscle thickness by ultrasound, movement range by goniometer, strength by dynamometer, and motion analysis using inertial sensors. The main outcome is shoulder functionality measured by the American Shoulder and Elbow Surgeons Scale, with additional functional scores and physiological fatigue assessments. This comprehensive monitoring aims to observe progress and safety over six months.

CONDITIONS

Brief Title

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with a reverse shoulder prosthesis
  • Age between 18 and 90 years
  • Signed informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants undergo surgery to receive a reverse shoulder prosthesis followed by either the REMOVE early multimodal physiotherapy program or standard physiotherapy care. The REMOVE program includes stages focused on mobility recovery, strengthening, intensive motor control improvement, and functional daily activities development.

5 visits: pre-surgery, baseline, 6 weeks, 12 weeks, and 24 weeks

Trial Site Locations

Total: 1 location

1

Antonio Cuesta Vargas

Málaga, Spain

Actively Recruiting

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Research Team

A

Antonio I Cuesta-Vargas, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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