Rotator Cuff InjuriesNCT06744218
Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery
A study testing Standard Treatment and Experimental Treatment in people with Rotator Cuff Injuries, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Standard Treatment and Experimental Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Nov 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous shoulder surgeries
- difficulty understanding the Italian language/language barrier
- unavailability of IT devices or stable wi-fi connection by the patient
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Istituto ortopedico Rizzoli
Bologna, Italia, 40136
Silvana Sartini, MD, 0516366 ext. 051
- Not yet recruiting
Ospedale del Delta
Lagosanto, Ferrara, 44023
elisabetta zucchini
About this study
Official title: 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.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Standard Treatment, Experimental Treatment
- Keywords
- telerehabilitation, physiotherapist, rotator cuff repair surgery
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TreatmentProcedure or surgery
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 TreatmentProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Not described Receives: Procedure: Standard Treatment |
| experimental | Experimental | Not described Receives: Procedure: Experimental Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley Score
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
Measured: At baseline (day 0), after one months, after 3 months
Secondary outcomes (3)
Mobility of the shoulder
Range of motion of the shoulder seen by movements made during the rehabilitation
Measured: At baseline (day 0), after one months, after 3 months
Numeric rating scale
Description of pain by numeric rating scale, from 0 no pain, to 10 worst pain ever (0-10)
Measured: At baseline (day 0), after one months, after 3 months
Disabilities of the Arm, Shoulder and Hand
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
Measured: at baseline, after 3 months and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start22 Nov 2024
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744218
- Sponsor's protocol ID
- Teleriab-Cuffia
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2024
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery: Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06744218
- Acronym / sponsor ID
- Teleriab-Cuffia
- Conditions
- Rotator Cuff Injuries
- Keywords
- telerehabilitation, physiotherapist, rotator cuff repair surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Procedure: Standard Treatment |
| experimental | Experimental | Procedure: Experimental Treatment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Previous shoulder surgeries
- difficulty understanding the Italian language/language barrier
- unavailability of IT devices or stable wi-fi connection by the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TreatmentPatients 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 | Procedure or surgery | Standard |
| Experimental Treatmentpatients 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 | Procedure or surgery | experimental |
Primary outcome
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
3 secondary outcomes
Mobility of the shoulder
Time frame: 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
Disabilities of the Arm, Shoulder and Hand
Time frame: at baseline, after 3 months and after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment and Experimental Treatment in people with Rotator Cuff Injuries, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvana Sartini, MD (0516366 ext. 051, silvana.sartini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (time frame: At baseline (day 0), after one months, after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.