Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-25 @ 2:52 PM
Study NCT ID:
NCT06851650
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Adding Early Scapular Muscles Strengthening Exercise After Rotator Cuff Repair on Scapula Kinematics
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upward rotation of the scapula', 'timeFrame': 'At week 3 and week 9 and week 12 after arthroscopic rotator cuff repair', 'description': 'Measuring the degree of upward rotation of the scapula during shoulder elevation using baseline bubble inclinometer'}], 'secondaryOutcomes': [{'measure': 'glenohumeral shoulder elevation', 'timeFrame': 'At week 3 and week 9 and week 12 after arthroscopic rotator cuff repair', 'description': 'Measuring the degree of glenohumeral shoulder elevation using baseline bubble inclinometer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator cuff repair Rehabilition, scapular upward rotation, scapular strengthen exercise', 'accelerate rehabilitation protocol'], 'conditions': ['Rotator Cuff Injuries', 'Rotator Cuff Repair Rehabilition', 'Supraspinatus Tear']}, 'descriptionModule': {'briefSummary': 'The study investigates the effect of accelerate rehabilitation protocol(adding scapular strengthen exercises (lower trapezius and serratus anterior) from week 1) after arthroscopic rotator cuff repair on scapular upward rotation during shoulder elevation.', 'detailedDescription': 'the study will consist of 2 group Both groups will participate in an accelerated rehabilitation program starting the first week after surgery till week 12, but they will follow different protocols. Accelerated rehabilitation protocol with Early Strengthening of Scapular stabilizer muscle (LT and SA) and GH Active range of motion protocol will be starting gradual active ROM for GH from week 3 post operative till week 12 and gradual scapular muscles strengthening exercises (serratus anterior, lower trapezius) from day 1 while Accelerated rehabilitation protocol with Delay strengthening of Scapular stabilizer muscles and Active GH range of motion protocol will start active ROM for GH and scapular activation exercises (protraction, retraction, and depression) from week 6 till week 12. Patients will wear the sling for the first 6 weeks or as the physician recommends and remove it only during the session and home program.\n\n7 The outcomes will be measured 3 times, at week 3 as a baseline for assessment, then reassess at weeks 6, and 12'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients after arthroscopic rotator cuff repair.\n2. Both gender between age 30 to 50 years\n3. Small and medium supraspinatus tear'}, 'identificationModule': {'nctId': 'NCT06851650', 'briefTitle': 'Efficacy of Adding Early Scapular Muscles Strengthening Exercise After Rotator Cuff Repair on Scapula Kinematics', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Early Strengthening of Lower Trapezius and Serratus Anterior Muscles in an Accelerated Rehabilitation Program After Rotator Cuff Repair', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early strengthening of Scapular stabilizer muscle and GH Active range of motion', 'description': 'Act as study group will receive accelerated protocol with early strengthening of scapular stabilizer muscle of lower trapezius, and serratus anterior and early active GH range of motion (AESA) rehabilitation program.', 'interventionNames': ['Other: Rehabilition protocol after rotator cuff repair surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delay strengthening of Scapular stabilizer muscles and GH Active range of motion', 'description': 'Act as control group will receive Accelerated protocol with delay strengthening of scapular stabilizer muscles and GH active range of motion (ADSA) rehabilitation program', 'interventionNames': ['Other: Rehabilition protocol after rotator cuff repair surgery']}], 'interventions': [{'name': 'Rehabilition protocol after rotator cuff repair surgery', 'type': 'OTHER', 'description': 'adding early scapular strengthening (lower trapezius and serratus anterior) exercise in Rehabilition program after rotator cuff repair surgery', 'armGroupLabels': ['Delay strengthening of Scapular stabilizer muscles and GH Active range of motion', 'Early strengthening of Scapular stabilizer muscle and GH Active range of motion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexsandria', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Wengat Hospital'}], 'centralContacts': [{'name': 'Ramy Zohdy Ali', 'role': 'CONTACT', 'email': 'aliramy767@gmail.com', 'phone': 'Egypt : 01284619898'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor doctor', 'investigatorFullName': 'Jilan Adel yousef', 'investigatorAffiliation': 'Cairo University'}}}}