Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT06744218
Status:
RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant-Murley Score', 'timeFrame': 'At baseline (day 0), after one months, after 3 months', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Mobility of the shoulder', 'timeFrame': 'At baseline (day 0), after one months, after 3 months', 'description': 'Range of motion of the shoulder seen by movements made during the rehabilitation'}, {'measure': 'Numeric rating scale', 'timeFrame': 'At baseline (day 0), after one months, after 3 months', 'description': 'Description of pain by numeric rating scale, from 0 no pain, to 10 worst pain ever (0-10)'}, {'measure': 'Disabilities of the Arm, Shoulder and Hand', 'timeFrame': 'at baseline, after 3 months and after 6 months', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['telerehabilitation', 'physiotherapist', 'rotator cuff repair surgery'], 'conditions': ['Rotator Cuff Injuries']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged between 40 and 70 years\n* Patients undergoing arthroscopic repair surgery of the rotator cuff tendons\n* Start of outpatient treatment within 7 days of discharge from the Orthopedic Department of the Argenta and Delta hospitals\n* 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.\n* Patients who have provided informed consent\n\nExclusion Criteria:\n\n* Previous shoulder surgeries\n* difficulty understanding the Italian language/language barrier\n* unavailability of IT devices or stable wi-fi connection by the patient'}, 'identificationModule': {'nctId': 'NCT06744218', 'briefTitle': 'Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Effectiveness of Telerehabilitation as an Alternative to Outpatient Physiotherapy in the 1 Month After Arthroscopic Rotator Cuff Repair Surgery: Multicenter Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Teleriab-Cuffia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'interventionNames': ['Procedure: Standard Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'experimental', 'interventionNames': ['Procedure: Experimental Treatment']}], 'interventions': [{'name': 'Standard Treatment', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Standard']}, {'name': 'Experimental Treatment', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44023', 'city': 'Lagosanto', 'state': 'Ferrara', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'elisabetta zucchini', 'role': 'CONTACT'}], 'facility': 'Ospedale del Delta', 'geoPoint': {'lat': 44.76282, 'lon': 12.14005}}, {'zip': '40136', 'city': 'Bologna', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvana Sartini, MD', 'role': 'CONTACT', 'phone': '0516366', 'phoneExt': '051'}], 'facility': 'IRCCS Istituto ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Silvana Sartini, MD', 'role': 'CONTACT', 'email': 'silvana.sartini@ior.it', 'phone': '0516366', 'phoneExt': '051'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}