Effectiveness of Telerehabilitation in Shoulder Pathology
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
exercises supervised by videoconference
Intervention: telerehabilitation in physiotherapy (Procedure)
Face to face physiotherapy
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
Yolanda Marcen Roman
PhD
Instituto de Investigación Sanitaria Aragón