Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05209893
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2022-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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'}], '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-20', 'studyFirstSubmitDate': '2022-01-06', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Change from Baseline Pain at 8 weeks', 'description': 'On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'Change from Baseline Subjective Function at 8 weeks', 'description': 'WOMAC consists of 3 main headings: pain intensity, stiffness, and physical function. The total score ranges from 0 (no disability) to 96 (complete disability).'}, {'measure': 'Muscle Strength Test with Lafayette Hand Held Dynamometer', 'timeFrame': 'Change from Baseline Muscle Strength at 8 weeks', 'description': 'It is an objective muscle strength measurement tool. Measurements are made 3 times. A rest of 120 seconds is given between measurements. The highest measured value is noted.'}, {'measure': 'Proprioception Measurement with Baseline Bubble Inclinometer', 'timeFrame': 'Change from Baseline Proprioception at 8 weeks', 'description': 'The "absolute angle difference", which is the difference between the targeted angle and the angle realized by the patient in each repetition, is recorded. The arithmetic mean of the absolute angle difference of 3 repetitions is the result data.'}, {'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': 'Change from Baseline "Timed Up and Go" test performance at 8 weeks', 'description': 'Patients are asked to get up from a standard chair, walk 3 meters a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated.'}, {'measure': 'Five Times Sit to Stand Test (5TSTS)', 'timeFrame': 'Change from Baseline "Five Times Sit to Stand" test performance at 8 weeks', 'description': 'The test involves patients getting up and sitting again without support from a chair 5 times as soon as possible. Measurements are made with a stopwatch.'}, {'measure': '3-Meter Backward Walk Test (3MBW)', 'timeFrame': 'Change from Baseline "3-Meter Backward Walk" test performance at 8 weeks', 'description': 'It is determined by measuring a distance of 3 meters. Participants are asked to walk backwards safely but as quickly as possible and stop at the finish line. The time is recorded with a stopwatch.'}, {'measure': 'Modified Four Square Step Test (mFSST)', 'timeFrame': 'Change from Baseline "Modified Four Square Step" test performance at 8 weeks', 'description': 'A suitable ground is divided into four identical squares with a "+" shaped line. Squares are numbered clockwise with numbers 1-4. The patient takes steps on the 1, 2, 3 and 4 squares in sequence without pressing the lines.The test ends when the last foot contact is cut off from the square. The time is recorded with a stopwatch.'}], 'secondaryOutcomes': [{'measure': 'EQ-5D-5L', 'timeFrame': 'Change from Baseline General Quality of Life at 8 weeks', 'description': 'The patient is asked to indicate the state of health by marking the most appropriate expression in each of the five dimensions. Index score of the EQ-5D-5L is ranged between 1 to - 0.285. Higher scores indicate better quality of life. VAS score of the EQ-5D-5L is ranged between 0 to 100. Higher scores indicate better quality of life.'}, {'measure': 'Telemedicine Satisfaction Questionnaire', 'timeFrame': 'Change from Baseline General Telemedicine Satisfaction at 8 weeks', 'description': 'This questionnaire consists of 14 items. The level of satisfaction of the patients with the software or system from which they receive treatment or other remote rehabilitation services is evaluated. The tool uses a 5-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total score varies between 14-70 for 14 questions with a maximum of 5 points. Higher scores indicate better satisfaction.'}, {'measure': 'Telehealth Usability Questionnaire', 'timeFrame': 'Change from Baseline General Usability Satisfaction at 8 weeks', 'description': 'The questionnaire consists of 21 items evaluating the distance rehabilitation service. The questionnaire uses a 7-point Likert-type scale (1 = disagree, 7 = agree). The total score is calculated by summing up 21 items.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gonarthrosis', 'Knee Osteoarthritis'], 'conditions': ['Osteoarthritis', 'Knee Arthritis']}, 'referencesModule': {'references': [{'pmid': '37678215', 'type': 'DERIVED', 'citation': 'Tumturk I, Bakirhan S, Ozden F, Gultac E, Kilinc CY. Effect of Telerehabilitation-Based Exercise and Education on Pain, Function, Strength, Proprioception, and Psychosocial Parameters in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2024 Mar 1;103(3):222-232. doi: 10.1097/PHM.0000000000002335. Epub 2023 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'Video exercise component of the telerehabilitation would provide additional contribution to the patients. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.', 'detailedDescription': 'Owing to telerehabilitation, exercise video suppliment will enable individuals to learn the exercise programs in the most appropriate way, have comprehensive information about their condition, and communicate easily with their physiotherapists. The aim of this study is to compare the effects of telerehabilitation-based exercise program and conventional (given on paper) exercise and training combination practices on pain, functionality, balance, proprioception and quality of life in patients with knee OA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 40 to 65 years\n* Being diagnosed with knee osteoarthritis by an orthopedist\n* Having a value of 1 or 2 in the Kellgren Lawrence classification\n* Having and being able to use the equipment to receive video-based exercise and education support\n* Having signed the consent form\n\nExclusion Criteria:\n\n* Situations that will prevent assessments or communication with the individual\n* Knee surgery history\n* Having other joint pathologies\n* Orthopedic and neurological problems that would prevent evaluation and/or treatment'}, 'identificationModule': {'nctId': 'NCT05209893', 'briefTitle': 'The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'The Effect of Telerehabilitation-Based Exercise and Training Combination on Pain, Function, Balance, Proprioception and Quality of Life in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '24/III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation (TR)', 'description': 'The TR group will be followed up through the application within the 8-week home exercise program.', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paper Based Rehabilitation (PBR)', 'description': 'The PBR group will be followed up through the paper instruction within the 8-week home exercise program.', 'interventionNames': ['Other: Paper Based Rehabilitation']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'Application based video home exercise for the knee osteoarthritis', 'armGroupLabels': ['Telerehabilitation (TR)']}, {'name': 'Paper Based Rehabilitation', 'type': 'OTHER', 'description': 'Paper instruction based home exercise for the knee osteoarthritis', 'armGroupLabels': ['Paper Based Rehabilitation (PBR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Muğla Sıtkı Koçman Training and Research Hospital', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Fatih Özden, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muğla Sıtkı Koçman University'}, {'name': 'Cem Yalın Kılınç, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muğla Sıtkı Koçman University'}, {'name': 'Emre Gültaç, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muğla Sıtkı Koçman University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd, Associate Professor', 'investigatorFullName': 'Serkan Bakırhan', 'investigatorAffiliation': 'Ege University'}}}}