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Clinical Trials/NCT07321444
NCT07321444
Recruiting
Not Applicable

Effectiveness of Telerehabilitation in Shoulder Pathology

Instituto de Investigación Sanitaria Aragón1 site in 1 country68 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Instituto de Investigación Sanitaria Aragón
Enrollment
68
Locations
1
Primary Endpoint
Shoulder functionality

Overview

Brief Summary

A randomized clinical trial will be conducted to evaluate the effectiveness of telerehabilitation compared to in-person physiotherapy in the treatment of rotator cuff injuries of the shoulder. Follow-up assessments will be performed at 2, 5, and 8 weeks. Scales will be used to evaluate shoulder function, quality of life, pain perception, and satisfaction with the digital tool.

Detailed Description

Digital health is undergoing significant development in various healthcare settings, especially in primary care. Digital physiotherapy, or telerehabilitation, is a resource that promotes self-care and allows for remote monitoring and follow-up. This study focuses on its application to degenerative rotator cuff disease of the shoulder. This is justified by its high prevalence and the geographical dispersion of the population served by the Primary Care Physiotherapy Unit of Teruel Ensanche. Objectives: The main objective is to evaluate the effectiveness of a primary care telerehabilitation program for patients with degenerative rotator cuff disease of the shoulder, compared to traditional physiotherapy. Secondary objectives are to assess patients' perception and satisfaction with this intervention and to analyze the usability and acceptance of the telerehabilitation program. Methodology: A 12-week randomized clinical trial will be conducted at the Teruel Ensanche Health Center. A sample of 68 adults aged 34 to 87 years with degenerative rotator cuff disease of the shoulder was estimated. Participants require internet access and an electronic device. The variables measured: shoulder function (Constant-Murley test), degree of disability (DASH questionnaire), quality of life (COOP/WONCA questionnaire), and pain perception (numerical rating scale). The intervention group (IG) receive an individualized program with remotely guided and supervised exercises, supplemented by a weekly in-person session. The control group (CG) receive standard treatment: 10 in-person physiotherapy sessions, followed by unsupervised home exercises. Assessments will be conducte at baseline and at 2, 5, 8, and 12 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Minimum age
  • Diagnosis of degenerative shoulder rotator cuff disease.
  • Internet access.
  • Access to a video calling device.

Exclusion Criteria

  • Previous shoulder surgery.
  • Cognitive impairment that prevents them from performing the task.

Arms & Interventions

Telerehabilitation

Experimental

exercises supervised by videoconference

Intervention: telerehabilitation in physiotherapy (Procedure)

Face to face physiotherapy

Active Comparator

Face to face exercise sessions in the physiotherapy room

Intervention: face to face physiotherapy (Procedure)

Outcomes

Primary Outcomes

Shoulder functionality

Time Frame: At baseline, at 2, 5, 8, and 12 weeks.

Shoulder function will be analyzed using the test Constant Murley.A maximum total score of 100 indicates optimal health and mobility in this joint. The results are divided into four main categories: pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). It is essential to distinguish between scores below 60, which denote a severely dysfunctional state, and those above 80, which reflect optimal functionality.

Secondary Outcomes

  • Health-related quality of life(At baseline, and at 2, 5, 8, and 12 weeks.)
  • Level of shoulder disability(At baseline, 5 and 12 weeks)
  • Pain perception(At baseline, 2,5,8 and 12 weeks)
  • Level of satisfaction with telerehabilitation(At 12 weeks.)

Investigators

Sponsor
Instituto de Investigación Sanitaria Aragón
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yolanda Marcen Roman

PhD

Instituto de Investigación Sanitaria Aragón

Study Sites (1)

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