Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 10:13 AM
Study NCT ID:
NCT06238960
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Telerehabilitation in Continuity With Outpatient Physiotherapy After Total Hip Replacement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hip disability and Osteoarthritis Outcome score (HOOS)', 'timeFrame': 'At baseline (day 0)', 'description': 'The HOOS is a 40-item self-report questionnaire with 5 subscales. A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.'}, {'measure': 'Hip disability and Osteoarthritis Outcome score (HOOS)', 'timeFrame': 'After 8 weeks', 'description': 'The HOOS is a 40-item self-report questionnaire with 5 subscales. A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.'}, {'measure': 'Hip disability and Osteoarthritis Outcome score (HOOS)', 'timeFrame': 'After 12 weeks', 'description': 'The HOOS is a 40-item self-report questionnaire with 5 subscales. A normalized score is calculated for each subscale with 0 indicating extreme symptoms and 100 representing no symptoms.'}], 'secondaryOutcomes': [{'measure': 'Timed Up and GO (TUG)', 'timeFrame': 'After 8 weeks', 'description': 'The test measures the time (in seconds) it takes a patient to get up from a chair, walk 3 meters, reverse and sit back in the chair. It can be performed without aids or with the aid usually used by the patient to walk.'}, {'measure': 'Timed Up and GO (TUG)', 'timeFrame': 'After 12 weeks', 'description': 'The test measures the time (in seconds) it takes a patient to get up from a chair, walk 3 meters, reverse and sit back in the chair. It can be performed without aids or with the aid usually used by the patient to walk.'}, {'measure': 'Harris Hip Score (HHS)', 'timeFrame': 'After 8 weeks', 'description': 'a multi-disability measurement tool, validated and translated into Italian, composed of a questionnaire and a specific clinical examination which has the aim of evaluating ADL and function in subjects with hip pathology'}, {'measure': 'Harris Hip Score (HHS)', 'timeFrame': 'After 12 weeks', 'description': 'a multi-disability measurement tool, validated and translated into Italian, composed of a questionnaire and a specific clinical examination which has the aim of evaluating ADL and function in subjects with hip pathology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Hip Replacement', 'Telerehabilitation', 'Physiotherapy']}, 'referencesModule': {'references': [{'pmid': '35099447', 'type': 'RESULT', 'citation': 'Sadiq S, Ahmad A, Ahmed A, Khan I, Asim HM, Aziz A. Role of tele-rehabilitation in patients following total hip replacement: Systematic review of clinical trials. J Pak Med Assoc. 2022 Jan;72(1):101-107. doi: 10.47391/JPMA.832.'}, {'pmid': '32026820', 'type': 'RESULT', 'citation': 'Nelson M, Bourke M, Crossley K, Russell T. Telerehabilitation is non-inferior to usual care following total hip replacement - a randomized controlled non-inferiority trial. Physiotherapy. 2020 Jun;107:19-27. doi: 10.1016/j.physio.2019.06.006. Epub 2019 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'Total arthroplasty (THA) is the treatment of choice for severe osteoarthritis of the hip joint. Following this type of intervention, a multidisciplinary rehabilitation approach allows you to reduce pain and improve the ability to carry out activities of daily living (ADL), but it is not clear what the optimal rehabilitation program is. Recently, the use of telerehabilitation has increased over the years. Specifically, in treatment of patients following THA surgery, telerehabilitation is able to give similar results to the treatment performed in person terms of pain and function. The aim of this study is to verify whether telerehabilitation associated with In-person treatment is comparable in terms of pain, recovery functionality and patient participation and satisfaction, compared to those provided by rehabilitation alone in the presence of patients undergoing THA surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having undergone total hip replacement surgery (THA)\n* Start outpatient treatment within 7 days of discharge from the Orthopedic Department\n* Age between 50 and 80 years.\n* Continuation of rehabilitation treatments at the IOR Physical Medicine and Rehabilitation service in Argenta.\n* The subjects or any caregivers must be able to use an electronic device (PC, tablet, smartphone).\n\nExclusion Criteria:\n\n* patients undergoing revision of previous prosthesis surgery\n* difficulty understanding the Italian language/language barrier\n* unavailability stable wi-fi connection by the patient'}, 'identificationModule': {'nctId': 'NCT06238960', 'briefTitle': 'Effectiveness of Telerehabilitation in Continuity With Outpatient Physiotherapy After Total Hip Replacement.', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Effectiveness of Telerehabilitation in Continuity With Outpatient Physiotherapy After Total Hip Replacement: Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'TELERIABPTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation', 'description': 'the patients who will be randomized and subjected to the experimental treatment will undergo a physiotherapy treatment with a biweekly frequency which will be started at the same times as the standard group.\n\nAfter the sixth session, the process will continue through telerehabilitation until the end of outpatient treatment.', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional physiotherapy', 'description': 'Patients who will be randomized and subjected to standard treatment (usual care at our clinic) will undergo physiotherapy treatment on a bi-weekly basis in person.', 'interventionNames': ['Other: Traditional rehabilitation']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'the patient will undergo 10 session of tele rehabilitation in continuity with traditional physiotherapy', 'armGroupLabels': ['Telerehabilitation']}, {'name': 'Traditional rehabilitation', 'type': 'OTHER', 'description': 'the patient will undergo 16 session of outpatient physiotherapy rehabilitation', 'armGroupLabels': ['traditional physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'state': 'Italia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Ruggiero', 'role': 'CONTACT', 'email': 'marco.ruggiero@ior.it', 'phone': '3382001089'}], 'facility': 'IRCCS Istituto ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Marco Ruggiero', 'role': 'CONTACT', 'email': 'marco.ruggiero@ior.it', 'phone': '3382001089'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}