Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-02 @ 1:02 AM
Study NCT ID:
NCT06901661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2025-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telerehabilitation for Hip and Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069350', 'term': 'Telerehabilitation'}, {'id': 'D059039', 'term': 'Standard of Care'}], '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'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Borg rate of perceived exertion (RPE)', 'timeFrame': 'Evaluate every week for 5 weeks during each exercise session of the experimental group', 'description': '6-20 points rating, a score ≤11 will be considered as "low fatigue" and \\>11 as "high fatigue'}, {'measure': 'International Physical Activity Questionnaire-Short Form (IPAQ-SF)', 'timeFrame': 'The outcome measures will be recorded before and after finish all 5 week of the intervention', 'description': 'A questionnaire'}], 'primaryOutcomes': [{'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'The outcome measures will be recorded before and after finish all 5 week of the intervention', 'description': 'A questionnaire'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': 'The outcome measures will be recorded before and after finish all 5 week of the intervention', 'description': 'Static muscle strength of hip and knee flexors and extensors'}, {'measure': 'Range of motion', 'timeFrame': 'The outcome measures will be recorded before and after finish all 5 week of the intervention', 'description': 'The Range of motions of hip and knee flexion and extension'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Telerehabilitation', 'Osteoarthritis', 'Randomized controlled trial'], 'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': "Digital health utilization in the form of telerehabilitation is a popular technology that is very little researched for musculoskeletal disorders particularly hip and knee osteoarthritis (OA). The progression of OA will lead to total hip or knee replacement surgery. As a consequence, the advancing aging population leads to an increased burden on the healthcare system due to rising osteoarthritis. That's why, we will conduct a randomized controlled trial to explore the effectiveness of telerehabilitation in hip and knee osteoarthritis. This study will recruit OA patients into control and experimental groups. The control group will receive a patient education while the experimental group will undergo remote exercise sessions. Both groups will receive one supervised session a week for 5 weeks. The pre- and post-outcome measures will be recorded for functional status of hip and knee, muscle strength, and range of motions of the lower extremity. This innovative study will evaluate the effectiveness of a telemedicine intervention applied to a clinical population in Taiwan. The use of telerehabilitation interventions aims to reduce treatment and transportation costs, as well as save time for patients with OA. This digital health approach also helps to alleviate the workload of physiotherapists and rehabilitation doctors in clinics. The findings from this study could broaden the scope for using remote digital technology to assist clinical patients in diverse settings, especially those with limited or no hospital access.", 'detailedDescription': 'Purpose: To conduct a randomized controlled trial to explore the efficacy of telerehabilitation intervention for 5 weeks in a clinical population with hip and knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosed with hip or knee osteoarthritis within last one year\n2. having sub-acute or chronic symptoms of pain and functional disability\n3. living in an area served by high-speed Internet services (at least 512 kb/s in upload)\n4. living within an hour driving distance from the treating hospital\n5. physically fit to provide a written consent to participate in this study\n\nExclusion Criteria:\n\n1. taking sedatives, autoimmune, or other medication that can interfere with their exercise program\n2. any health issues that could affect the tests or the rehabilitation program, including surgery over the recent six months\n3. having diagnosed with cognitive disorders\n4. having recent surgery or major postoperative complications'}, 'identificationModule': {'nctId': 'NCT06901661', 'briefTitle': 'Telerehabilitation for Hip and Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University Shuang Ho Hospital'}, 'officialTitle': 'Telerehabilitation for Hip and Knee Osteoarthritis. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'TMU-IJRB-N202412017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation', 'description': 'Receive a remote exercise program for 40 minutes once a week for 5 weeks', 'interventionNames': ['Behavioral: Telerehabilitation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard care', 'description': 'Receive a patient education session once a week for 5 weeks', 'interventionNames': ['Behavioral: Standard care']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'BEHAVIORAL', 'description': 'Exercise program include Warm-up, Targeted muscle Strengthening, Joint mobilization, and Proprioception', 'armGroupLabels': ['Telerehabilitation']}, {'name': 'Standard care', 'type': 'BEHAVIORAL', 'description': 'Education session on their pain, disability, and functional activities', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '235', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Hung-Chou Chen, Dr.', 'role': 'CONTACT', 'email': 'b8601084@tmu.edu.tw', 'phone': '+886-2-22490088', 'phoneExt': '1603'}], 'facility': 'Taipei Medical University-Shuang Ho Hospital, Ministry of Health and Welfare', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Muhammad Adeel, Dr.', 'role': 'CONTACT', 'email': 'dr.adeel215@gm.ntpu.edu.tw', 'phone': '+886-2-86741111', 'phoneExt': '67123'}, {'name': 'Hung-Chou Chen, Dr.', 'role': 'CONTACT', 'email': 'b8601084@tmu.edu.tw', 'phone': '+886-2-22490088'}], 'overallOfficials': [{'name': 'Hung-Chou Chen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University Shuang Ho Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University Shuang Ho Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}