- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07321444
Telerehabilitation in Shoulder Pathology
Effectiveness of Telerehabilitation in Shoulder Pathology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aragon
-
Teruel, Aragon, Spain, 44002
- Teruel Ensanche Primary Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Minimum age 18.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation
exercises supervised by videoconference
|
Exercises supervised by videoconference.
|
|
Active Comparator: Face to face physiotherapy
Face to face exercise sessions in the physiotherapy room
|
Exercises performed in a physical therapy room.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline, at 2, 5, 8, and 12 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: At baseline, and at 2, 5, 8, and 12 weeks.
|
The COOP-WONCA questionnaire The COOP-WONCA questionnaire is a brief instrument for assessing health status and health-related quality of life (HRQoL), widely used in primary care and clinical studies to obtain a global and functional view of the patient's perceived health status. It consists of 7 items, and scores were processed using a 5-point Likert scale, with higher scores corresponding to a poorer quality of life. |
At baseline, and at 2, 5, 8, and 12 weeks.
|
|
Level of shoulder disability
Time Frame: At baseline, 5 and 12 weeks
|
Shoulder disability will be analyzed using the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand). The DASH consists of 30 items. Each question must be answered using a 5-point scale, where 1 indicates "No difficulty" and 5 indicates "Unable to perform." A higher score indicates greater disability. |
At baseline, 5 and 12 weeks
|
|
Pain perception
Time Frame: At baseline, 2,5,8 and 12 weeks
|
Pain perception will be analyzed using the Numerical Pain Rating Scale.
It is scored from 1 to 10.
The higher the score, the greater the perception of pain.
|
At baseline, 2,5,8 and 12 weeks
|
|
Level of satisfaction with telerehabilitation
Time Frame: At 12 weeks.
|
Satisfaction with the use of telerehabilitation will be measured using the TUQ questionnaire (Telehealth Usability Questionnaire).
It has 12 items, rated on a Likert scale from 1 to 7, the higher the score, the greater the satisfaction.
|
At 12 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C.P.-C.I. PI21-403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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