Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 2:26 PM
Study NCT ID:
NCT04388306
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2020-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shoulder Functional Performance After Shoulder Surgery
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-13', 'studyFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)', 'timeFrame': 'Three months', 'description': 'FIT-HaNSA is a test battery consisting of 3 tasks simulating overhead work and lifting activities designed to evaluate the shoulder functional performance.'}], 'secondaryOutcomes': [{'measure': 'Modified Constant Murley Score', 'timeFrame': 'Three months', 'description': 'Shoulder functionality was analyzed by using the MCMS evaluating pain, daily living activities, ROM and strength. Pain was evaluated by visual analog scale and ROM by goniometer. The force in the shoulder abduction position was measured with the Digital analyzer defined by the spring balance technique.'}, {'measure': 'Scapular Muscle Endurance Test', 'timeFrame': 'Three months', 'description': 'The scapular muscle endurance test evaluate the endurance of the serratus anterior and the trapezium muscles.'}, {'measure': 'Total Upper Extremity Muscle Strength', 'timeFrame': 'Three months', 'description': 'Total upper extremity muscle strength was evaluated with Jamar hand dynamometer. Grip strength is considered to be a valid value of TUEMS. The test was performed by measuring both sides.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tears']}, 'descriptionModule': {'briefSummary': 'Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.\n\nArthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.\n\nMany studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.\n\nTherefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.', 'detailedDescription': 'Design: observational Cross-sectional study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study group consists of participants with undergone arthroscopic RC repair at Bolu Abant İzzet Baysal University, Department of Orthopedics and Traumatology.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* With the same RC surgical procedure and technique,\n* With acromioplasty and/or tenodesis with RC repair,\n* Undergoing arthroscopic RC repair from the upper extremity of the dominant side,\n* Having completed the 12th week after surgery,\n* Performing 90° and above active shoulder elevation movement\n\nExclusion Criteria:\n\n* Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity\n* Having undergone surgery causing limitation of motion in the spine,\n* Having a neurological and/or vestibular and/or rheumatologic disease,\n* Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test'}, 'identificationModule': {'nctId': 'NCT04388306', 'briefTitle': 'Shoulder Functional Performance After Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors', 'orgStudyIdInfo': {'id': 'AIBU-FTR-BYD-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Group', 'description': 'Thirty-two participants with undergone arthroscopic Rotator Cuff repair', 'interventionNames': ['Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)']}, {'label': 'Control Group', 'description': 'Thirty-two healthy participants', 'interventionNames': ['Other: Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)']}], 'interventions': [{'name': 'Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)', 'type': 'OTHER', 'otherNames': ['Shoulder Functionality-Modified Constant Murley Score', 'Scapular Endurance-Scapular Muscle Endurance Test', 'Strength-Total Upper Extremity Muscle Strength'], 'description': 'Participants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test.', 'armGroupLabels': ['Control Group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Bolu', 'state': 'Central', 'country': 'Turkey (Türkiye)', 'facility': 'Bolu Abant Izzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'Beyza YAZGAN DAĞLI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abant Izzet Baysal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Beyza Yazgan Dagli', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}