- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744218
Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery
December 19, 2025 updated by: Istituto Ortopedico Rizzoli
Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery: Multicenter Randomized Clinical Trial
The present study aims to verify whether telerehabilitation as an alternative to in-person treatment (both conducted by a physiotherapist) can be a valid option in terms of pain, recovery of the rom, shoulder functionality compared to those provided by therapy alone.
face-to-face rehabilitation in patients undergoing arthroscopic rotator cuff repair surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Silvana Sartini, MD
- Phone Number: 051 0516366
- Email: silvana.sartini@ior.it
Study Locations
-
-
Ferrara
-
Lagosanto, Ferrara, Italy, 44023
- Not yet recruiting
- Ospedale del Delta
-
Contact:
- elisabetta zucchini
-
-
Italia
-
Bologna, Italia, Italy, 40136
- Recruiting
- IRCCS Istituto Ortopedico Rizzoli
-
Contact:
- Silvana Sartini, MD
- Phone Number: 051 0516366
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female patients aged between 40 and 70 years
- Patients undergoing arthroscopic repair surgery of the rotator cuff tendons
- Start of outpatient treatment within 7 days of discharge from the Orthopedic Department of the Argenta and Delta hospitals
- Continuation of rehabilitation care at the IOR Physical and Rehabilitation Medicine service in Argenta or at the Physical Therapy Rehabilitation Medicine service of the Delta Hospital.
- Patients who have provided informed consent
Exclusion Criteria:
- Previous shoulder surgeries
- difficulty understanding the Italian language/language barrier
- unavailability of IT devices or stable wi-fi connection by the patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard
|
Patients who will be assigned to the control group and subjected to standard treatment (usual care at our clinic) will undergo a physiotherapy treatment of 8 in-person sessions for 4 post-operative weeks
|
|
Experimental: experimental
|
patients who will be assigned to the experimental group and subjected to the experimental treatment will undergo a physiotherapy treatment of 8 sessions in telerehabilitation for 4 post-operative weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Constant-Murley Score
Time Frame: At baseline (day 0), after one months, after 3 months
|
The Constant-Murley score (CMS) is a 100-point scale made up of a series of individual parameters.
These parameters define the patient's pain level and ability to carry out normal daily activities
|
At baseline (day 0), after one months, after 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility of the shoulder
Time Frame: At baseline (day 0), after one months, after 3 months
|
Range of motion of the shoulder seen by movements made during the rehabilitation
|
At baseline (day 0), after one months, after 3 months
|
|
Numeric rating scale
Time Frame: At baseline (day 0), after one months, after 3 months
|
Description of pain by numeric rating scale, from 0 no pain, to 10 worst pain ever (0-10)
|
At baseline (day 0), after one months, after 3 months
|
|
Disabilities of the Arm, Shoulder and Hand
Time Frame: at baseline, after 3 months and after 6 months
|
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item questionnaire that examines a patient's ability to perform certain upper extremity activities
|
at baseline, after 3 months and after 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
December 16, 2024
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
December 20, 2024
Study Record Updates
Last Update Posted (Actual)
December 26, 2025
Last Update Submitted That Met QC Criteria
December 19, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Teleriab-Cuffia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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