Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-29 @ 11:51 AM
Study NCT ID:
NCT00998868
Status:
COMPLETED
Last Update Posted:
2011-09-30
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rotator Cuff Tears in Hemiplegic Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tairyoon@snu.ac.kr', 'phone': '+82-2-2072-3218', 'title': 'Tai Ryoon Han, MD, PhD./Professor', 'organization': 'Seoul National University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within one month after enrollment', 'description': 'All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within one month after enrollment', 'description': 'All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within one month after enrollment', 'description': 'The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '1.442', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within one month after enrollment', 'description': 'Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.\n\nMRC scale:\n\nGrade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement.', 'unitOfMeasure': 'Units on a scale (minimum 0, maximum 5)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '\\>=10 for each muscle strength per MRC scale, after excluding the cases following exclusion criteria', 'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: Jan, 2008 - Dec, 2009 Recruitment site: Seoul National University Eligible canditates from: inpatients in the department of rehabilitation medicine of the hospital Methods of recruitment: research physicians informed about the study to all eligible candidates and asked if they agreed to participate.', 'preAssignmentDetails': 'The study was designed to recruit hemiplegic patients of diverse degree of paresis with the same size. Because the crude distribution of the motor weakness was not even, the recruitment process adjusted the distribution of the severity of paresis, by recruiting patients of different motor strength in a consecutive way.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.37', 'spread': '10.765', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-23', 'studyFirstSubmitDate': '2009-10-20', 'resultsFirstSubmitDate': '2010-08-15', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-17', 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography', 'timeFrame': 'within one month after enrollment', 'description': 'All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.'}], 'secondaryOutcomes': [{'measure': 'Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography', 'timeFrame': 'within one month after enrollment', 'description': 'All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.'}, {'measure': 'Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination', 'timeFrame': 'within one month after enrollment', 'description': 'The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.'}, {'measure': 'Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System', 'timeFrame': 'within one month after enrollment', 'description': 'Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group.\n\nMRC scale:\n\nGrade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotator Cuff', 'Tendinopathy', 'ultrasonography'], 'conditions': ['Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '16551396', 'type': 'BACKGROUND', 'citation': "Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968."}, {'pmid': '10633891', 'type': 'BACKGROUND', 'citation': 'Sano H, Ishii H, Trudel G, Uhthoff HK. Histologic evidence of degeneration at the insertion of 3 rotator cuff tendons: a comparative study with human cadaveric shoulders. J Shoulder Elbow Surg. 1999 Nov-Dec;8(6):574-9. doi: 10.1016/s1058-2746(99)90092-7.'}, {'pmid': '15219895', 'type': 'BACKGROUND', 'citation': 'Yu D. Shoulder pain in hemiplegia. Phys Med Rehabil Clin N Am. 2004 Aug;15(3):vi-vii, 683-97. doi: 10.1016/S1047-9651(03)00130-X.'}, {'pmid': '11732559', 'type': 'BACKGROUND', 'citation': 'Bender L, McKenna K. Hemiplegic shoulder pain: defining the problem and its management. Disabil Rehabil. 2001 Nov 10;23(16):698-705. doi: 10.1080/09638280110062149.'}, {'pmid': '15015899', 'type': 'BACKGROUND', 'citation': 'Gilmore PE, Spaulding SJ, Vandervoort AA. Hemiplegic shoulder pain: implications for occupational therapy treatment. Can J Occup Ther. 2004 Feb;71(1):36-46. doi: 10.1177/000841740407100108.'}, {'pmid': '3942479', 'type': 'BACKGROUND', 'citation': 'Van Ouwenaller C, Laplace PM, Chantraine A. Painful shoulder in hemiplegia. Arch Phys Med Rehabil. 1986 Jan;67(1):23-6.'}, {'pmid': '1580765', 'type': 'BACKGROUND', 'citation': 'Joynt RL. 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Experimental distal subluxation in the glenohumeral joint. Arch Orthop Trauma Surg (1978). 1985;104(2):78-81. doi: 10.1007/BF00454241.'}, {'pmid': '11222932', 'type': 'BACKGROUND', 'citation': "Halder AM, Halder CG, Zhao KD, O'Driscoll SW, Morrey BF, An KN. Dynamic inferior stabilizers of the shoulder joint. Clin Biomech (Bristol). 2001 Feb;16(2):138-43. doi: 10.1016/s0268-0033(00)00077-2."}, {'pmid': '18509565', 'type': 'BACKGROUND', 'citation': 'Niessen M, Janssen T, Meskers C, Koppe P, Konijnenbelt M, Veeger D. Kinematics of the contralateral and ipsilateral shoulder: a possible relationship with post-stroke shoulder pain. J Rehabil Med. 2008 Jun;40(6):482-6. doi: 10.2340/16501977-0201.'}, {'pmid': '19062307', 'type': 'BACKGROUND', 'citation': 'Diederichsen LP, Norregaard J, Dyhre-Poulsen P, Winther A, Tufekovic G, Bandholm T, Rasmussen LR, Krogsgaard M. The activity pattern of shoulder muscles in subjects with and without subacromial impingement. J Electromyogr Kinesiol. 2009 Oct;19(5):789-99. doi: 10.1016/j.jelekin.2008.08.006. Epub 2008 Dec 4.'}, {'pmid': '17690321', 'type': 'BACKGROUND', 'citation': 'Gold GE, Pappas GP, Blemker SS, Whalen ST, Campbell G, McAdams TA, Beaulieu CF. Abduction and external rotation in shoulder impingement: an open MR study on healthy volunteers initial experience. Radiology. 2007 Sep;244(3):815-22. doi: 10.1148/radiol.2443060998. Epub 2007 Aug 9.'}, {'pmid': '19253350', 'type': 'BACKGROUND', 'citation': 'Pong YP, Wang LY, Wang L, Leong CP, Huang YC, Chen YK. Sonography of the shoulder in hemiplegic patients undergoing rehabilitation after a recent stroke. J Clin Ultrasound. 2009 May;37(4):199-205. doi: 10.1002/jcu.20573.'}, {'pmid': '17564776', 'type': 'BACKGROUND', 'citation': 'Kim HA, Kim SH, Seo YI. Ultrasonographic findings of painful shoulders and correlation between physical examination and ultrasonographic rotator cuff tear. Mod Rheumatol. 2007;17(3):213-9. doi: 10.1007/s10165-007-0577-8. Epub 2007 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity.', 'detailedDescription': 'Rotator cuff tears are often suspected to contribute hemiplegic shoulder pain. However, it is controversial whether their incidence increases in hemiplegia. Based on the postulate that muscle weakness in hemiplegia predisposes rotator cuff injury due to biomechanical failure, this study aims to investigate whether the rotator cuff tears are associated with the muscle strength of the shoulder by observing hemiplegic shoulders of varying degree of paresis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'university hospital, department of rehabilitation medicine admitted patients due to hemiplegia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemiplegia; unilateral weakness of sudden onset\n* secondary to strokes or other brain lesions\n* compatible with brain lesions confirmed by imaging studies\n\nExclusion Criteria:\n\n* bilateral weakness\n* any history of intensive trauma of the shoulder, reported\n* preexisting musculoskeletal disorder of the shoulder'}, 'identificationModule': {'nctId': 'NCT00998868', 'briefTitle': 'Rotator Cuff Tears in Hemiplegic Shoulder', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Observational Study to Evaluate the Prevalence of Rotator Cuff Tears in Hemiplegic Shoulders', 'orgStudyIdInfo': {'id': 'SNUH-RM-TRHan-RCTHS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hemiplegia', 'description': 'patients with hemiplegia, without other musculoskeletal disorders of the shoulder'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Tai Ryoon Han, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sun Gun Chung', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}