Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2026-01-01 @ 8:53 PM
Study NCT ID:
NCT05719350
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telerehabilitation in Patients With Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rating of Pain', 'timeFrame': 'one Month', 'description': 'rating of pain in the knee joint with osteoarthritis measured with the nprs pain scale'}], 'secondaryOutcomes': [{'measure': 'Quality of life improvement', 'timeFrame': 'one month, three month', 'description': 'Improved quality of life as measured by the Short Form Health Survey scale'}, {'measure': 'Assessment of knee joint function', 'timeFrame': 'one month, three month', 'description': 'Assessment of knee joint function as measured by the Womac scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Randomized controlled study on the effectiveness of Telerehabilitation intervention on subjects with knee osteoarthritis. Subjects will be randomized into two groups. The experimental group perform 3 sessions a week for 4 weeks of TR, the control group 3 sessions a week for 4 weeks of conventional rehabilitation c/o IOR rehabilitation gym. Follow-up at 3 months.\n\nInclusion criteria\n\n1. Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more indications, OARSI criteria.\n2. Male or Female, aged \\> 18 years\n3. Participant is willing and able to provide informed consent for participation in the study.\n4. Subjects must be able to use an electronic device (pc, tablet, smartphone). Exclusion criteria\n\n1\\. Participation in another clinical study with any investigational agent within 30 days prior of the study screening.\n\n2\\. Inability to use an electronic device (pc, tablet, smartphone) 4. Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal.\n\n5\\. Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological.\n\n6\\. Children under the age of 18 8. NPRS value \\<3 7. BMI \\>25'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more articulations, OARSI criteria.\n* Male or Female, aged \\> 18 years\n* Participant is willing and able to provide informed consent for participation in the\n* study.\n* Subjects must be able to use\n\nExclusion Criteria:\n\n* Participation in another clinical study with any investigational agent within 30 days prior\n* of the study screening.\n* Inability to use an electronic device (pc, tablet, smartphone)\n* Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal.\n* Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological.\n* hildren under the age of 18\n* Numeric Pain Rating Scale(NPRS) value \\<3\n* BMI \\>25'}, 'identificationModule': {'nctId': 'NCT05719350', 'acronym': 'TABLET', 'briefTitle': 'Telerehabilitation in Patients With Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Effectiveness of Telerehabilitation in Patients With Osteoarthritis. A Randomized Controlled', 'orgStudyIdInfo': {'id': '0001333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Tele-rehabilitation exercises for the knee joint to reduce pain', 'interventionNames': ['Other: Exercises for Knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Exercises in presence for the knee joint to decrease pain', 'interventionNames': ['Other: Exercises for Knee']}], 'interventions': [{'name': 'Exercises for Knee', 'type': 'OTHER', 'description': 'Four exercises for strengthening and mobility of the knee joint two in a sitting position and two in a standing position for a total of 20-25 minutes', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40141', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Roberto Tedeschi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Maria Grazia Benedetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Ortopedico Rizzoli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}