NCT06744218

Brief 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. face-to-face rehabilitation in patients undergoing arthroscopic rotator cuff repair surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Nov 2024Nov 2026

Study Start

First participant enrolled

November 22, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 16, 2024

Last Update Submit

December 19, 2025

Conditions

Keywords

telerehabilitationphysiotherapistrotator cuff repair surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    At baseline (day 0), after one months, after 3 months

Secondary Outcomes (3)

  • Mobility of the shoulder

    At baseline (day 0), after one months, after 3 months

  • Numeric rating scale

    At baseline (day 0), after one months, after 3 months

  • Disabilities of the Arm, Shoulder and Hand

    at baseline, after 3 months and after 6 months

Study Arms (2)

Standard

ACTIVE COMPARATOR
Procedure: Standard Treatment

experimental

EXPERIMENTAL
Procedure: Experimental Treatment

Interventions

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

experimental

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

Standard

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous shoulder surgeries
  • difficulty understanding the Italian language/language barrier
  • unavailability of IT devices or stable wi-fi connection by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ospedale del Delta

Lagosanto, Ferrara, 44023, Italy

NOT YET RECRUITING

IRCCS Istituto ortopedico Rizzoli

Bologna, Italia, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

Silvana Sartini, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 20, 2024

Study Start

November 22, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations