Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT06024551
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2023-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy
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'}]}, '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': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario Rotator Cuff Index', 'timeFrame': 'one month', 'description': 'Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.'}, {'measure': 'Simple Shoulder Test', 'timeFrame': 'one month', 'description': 'A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.'}], 'secondaryOutcomes': [{'measure': 'Range of motion', 'timeFrame': 'one month', 'description': 'Shoulder joint normal range of motion will be measured using a goniometer. Normal movements of the shoulder joint are flexion 180 degrees, abduction 180 degrees, hyperextension 45 degrees, internal rotation 70 degrees and external rotation 90 degrees. Limitations will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rotator cuff tendinopathy', 'telerehabilitation'], 'conditions': ['Rotator Cuff Injuries', 'Rotator Cuff Tendinitis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the effect of telerehabilitation in patients with rotator cuff tendinopathy. The main questions it aims to answer are:\n\n* Is telerehabilitation effective in improving the functional status of patients with rotator cuff tendinopathy?\n* Is telerehabilitation effective in reducing the pain of rotator cuff patients?', 'detailedDescription': 'Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be included in the study. Patients will be divided into two groups. Patients in group 1 will be given a home exercise program. Then, the patients will be called 3 times a week and it will be evaluated whether they do their exercises regularly and whether they do it correctly. At the end of the first month, the patients will be evaluated again for functionality and pain.\n\nThe patients in group 2 will be given a home exercise program and at the end of the first month, the patients will be evaluated again in terms of functionality and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Rotator cuff tendinopathy\n* Being able to do the prescribed exercises\n* Having an access to internet and having a computer or smart phone for telerehabilitation\n\nExclusion Criteria:\n\n* Patients with a neurological disease that may affect the effectiveness of exercise\n* History of fracture in shoulder region\n* History of surgery in shoulder region\n* Patients with a psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT06024551', 'briefTitle': 'Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Democracy University'}, 'officialTitle': 'Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy', 'orgStudyIdInfo': {'id': 'TR35TR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Patients who receive telerehabilitation', 'interventionNames': ['Other: Telerehabilitation']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Patients who receive home exercise program', 'interventionNames': ['Other: home exercise program']}], 'interventions': [{'name': 'Telerehabilitation', 'type': 'OTHER', 'description': 'Patients in this arm will be given telerehabilitation three times a week, for four weeks.', 'armGroupLabels': ['Intervention Group']}, {'name': 'home exercise program', 'type': 'OTHER', 'description': 'Patients in this arm will receive home exercise program for four weeks', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Democracy University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Ferruh Taşpınar', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Izmir Democracy University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Democracy University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ferruh Taşpınar', 'investigatorAffiliation': 'Izmir Democracy University'}}}}