Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT04181151
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Activation of Latissimus Dorsi Muscle Segments During Functional Reach Activity in Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface electromyographic measurement', 'timeFrame': '90 minutes', 'description': 'Muscle activation measurement\n\nIt is an 8-channel system for measuring signals come from muscles (Noraxon Telemyo DTS system, Scottsdale, USA).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['latissimus dorsi', 'stroke', 'electromyography', 'reaching activity', 'muscle activation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '11415812', 'type': 'BACKGROUND', 'citation': 'Bogduk N, Johnson G, Spalding D. The morphology and biomechanics of latissimus dorsi. Clin Biomech (Bristol). 1998 Sep;13(6):377-385. doi: 10.1016/s0268-0033(98)00102-8.'}, {'pmid': '14966711', 'type': 'BACKGROUND', 'citation': 'Dickstein R, Shefi S, Marcovitz E, Villa Y. Anticipatory postural adjustment in selected trunk muscles in post stroke hemiparetic patients. Arch Phys Med Rehabil. 2004 Feb;85(2):261-7. doi: 10.1016/j.apmr.2003.05.011.'}, {'pmid': '9720999', 'type': 'BACKGROUND', 'citation': 'Wickham JB, Brown JM. Muscles within muscles: the neuromotor control of intra-muscular segments. Eur J Appl Physiol Occup Physiol. 1998 Aug;78(3):219-25. doi: 10.1007/s004210050410.'}, {'pmid': '16458022', 'type': 'BACKGROUND', 'citation': 'Brown JM, Wickham JB, McAndrew DJ, Huang XF. Muscles within muscles: Coordination of 19 muscle segments within three shoulder muscles during isometric motor tasks. J Electromyogr Kinesiol. 2007 Feb;17(1):57-73. doi: 10.1016/j.jelekin.2005.10.007. Epub 2006 Feb 2.'}, {'pmid': '11018445', 'type': 'BACKGROUND', 'citation': 'Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.'}, {'pmid': '37004380', 'type': 'DERIVED', 'citation': 'Kaya Benli T, Kara D, Dulger E, Bilgin S. Electromyography study of six parts of the latissimus dorsi during reaching tasks while seated: A comparison between healthy subjects and stroke patients. J Electromyogr Kinesiol. 2023 Jun;70:102770. doi: 10.1016/j.jelekin.2023.102770. Epub 2023 Mar 25.'}], 'seeAlsoLinks': [{'url': 'http://seniam.org/', 'label': 'SENIAM'}]}, 'descriptionModule': {'briefSummary': 'Latissimus Dorsi (LD); Medial sacrum, lumbar vertebrae and lower thoracic vertebrae 10-12 lateral to the spinous processus. It is a fan-like wide muscle that connects to the inferior angle of the scapula and ribs, adheres to the anterior surface of the proximal humerus and continues with aponeurosis of the contralateral Gluteus Maximus below. The activation of the LD muscle during the functional reach activity, which we use most frequently in daily living activities, affects the upper extremity and trunk movements. Therefore it is important muscle that affects the quality of movement.\n\nThe study include individuals with stroke that diagnosed by the neurologist and include healthy subjects. During sitting activity, they will be required to reach three different distances in the sagittal and scapular plane: arm length, 125% of the arm length and end point where it can reach the modified functional reach test. During the activity, electromyography (EMG) activation of latissimus dorsi, anterior deltoid and erector spina muscles will be examined with electromyographic device.\n\nHypothesis originating from the investigation:\n\nH1: Latissimus dorsi muscle segments show different activation during functional reach activity.\n\nH2: Activation of latissimus dorsi muscle segments is affected by reaching direction during functional reach activity.\n\nH3: Activation of latissimus dorsi muscle segments is affected by reaching distance during functional reach activity.', 'detailedDescription': "Measurements will be made during the sitting activity of the individuals included in the study. Individuals will be asked to reach midsternal height cups in two separate planes, sagittal and scapular, at arm's end, 125% of arm's distance and end point where it can reach according to modified functional reach test.\n\nMuscle activation of latissimus dorsi, erector spina and anterior deltoid muscles will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM for erector spina and anterior deltoid will be evaluated. For latissimus dorsi, activation will be measured in six segments separated according to anatomic dissection.\n\nReach activity will be performed 3 times on each side and at 1 minute intervals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hacettepe University Neurological Rehabilitation Unit', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with stroke by a neurologist\n* least 6 mounts after stroke\n* Fugl Meyer Upper Extremity Motor Rating Scale with a value of 40 and above,\n* independent sitting,\n* Mini Mental Status Scale (MMSE)\\> 24,\n* 30-67 age.\n\nExclusion Criteria:\n\n* neurodegenerative disease other than stroke\n* presence of neglect\n* presence of apraxia\n* uncorrected visual impairment\n* neuromusculoskeletal pathologies\n* neck and shoulder pain lasting more than 3 months'}, 'identificationModule': {'nctId': 'NCT04181151', 'briefTitle': 'Investigation of Activation of Latissimus Dorsi Muscle Segments During Functional Reach Activity in Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of Activation of Latissimus Dorsi Muscle Segments During Functional Reach Activity in Chronic Stroke Patients', 'orgStudyIdInfo': {'id': 'Hacettepe U'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke patients', 'interventionNames': ['Other: Electromyographic device']}, {'label': 'Healthy Subjects', 'interventionNames': ['Other: Electromyographic device']}], 'interventions': [{'name': 'Electromyographic device', 'type': 'OTHER', 'description': 'An 8-channel surface EMG system (Noraxon Telemyo DTS system, Scottsdale, USA) will be used to measure signals from muscles during surface electromyography measurements.', 'armGroupLabels': ['Healthy Subjects', 'Stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Sıhhiye/ANKARA', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Tuba KAYA, R.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Sevil BİLGİN, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}, {'name': 'Muhammed KILINÇ, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Esra DÜLGER, R.A.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Tuba Kaya Benli', 'investigatorAffiliation': 'Hacettepe University'}}}}