Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04042818
Status:
UNKNOWN
Last Update Posted:
2019-08-02
First Post:
2019-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reliability of Rehabilitative Ultrasound for the Quadriceps Muscle and Sarcopenia in Poststroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2019-07-20', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickness of Rectus Femoris Muscle', 'timeFrame': 'One week', 'description': 'Longitudinal and Transverse thickness of rectus femoris muscle'}, {'measure': 'Thickness of vastus intermedius muscle', 'timeFrame': 'One week', 'description': 'Longitudinal and Transverse thickness of vastus intermedius muscle'}, {'measure': 'Cross-sectional area of Rectus Femoris Muscle', 'timeFrame': 'One week', 'description': 'Cross-sectional area of Rectus Femoris Muscle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcopenia', 'Stroke', 'Quadriceps Muscle Atrophy', 'Hemiplegia', 'Ultrasonography', 'Hand Strength'], 'conditions': ['Sarcopenia', 'Stroke, Complication', 'Quadriceps Muscle Atrophy', 'Hemiplegia', 'Ultrasonography', 'Hand Strength']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.', 'detailedDescription': 'Poststroke patients often suffer from muscle atrophy in quadriceps muscle. Quadriceps muscle is essential for independent standing or ambulation after stroke. Quadriceps muscle consists of four different muscles: rectus femoris, vastus intermedius, vastus lateralis and medialis. The present study search for reliability for rectus femoris and vastus intermedius muscle thickness and cross-sectional area using rehabilitative ultrasound imagining. Longitudinal and transverse ultrasound imagining of the muscle thickness will be performed on both rectus femoris and vastus intermedius muscles for both extremities. The procedures will be repeated by two experts at two separate times (7-10 days). For sarcopenia measurement grip strength and DEXA measurements of the patients will be calculated. Totally 68 patients will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Poststroke patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poststroke patients (\\>6 months)\n\nExclusion Criteria:\n\n* \\< 6 months after stroke\n* Multiple stroke'}, 'identificationModule': {'nctId': 'NCT04042818', 'briefTitle': 'Reliability of Rehabilitative Ultrasound for the Quadriceps Muscle and Sarcopenia in Poststroke Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Reliability of Rehabilitative Ultrasound Imaging for the Quadriceps Muscle and Sarcopenia in Poststroke Patients', 'orgStudyIdInfo': {'id': 'GaziosmanpasaTREH7'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rehabilitative Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound imagining'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34255', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Akif Guler', 'role': 'CONTACT', 'email': 'makifguler89@gmail.com', 'phone': '5054930098'}], 'facility': 'Gaziosmanpasa Taksim Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Mehmet A Guler, M.D.', 'role': 'CONTACT', 'email': 'makifguler89@gmail.com', 'phone': '+905054930098'}, {'name': 'Zeynel Karakullukçuoğlu, M.D.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ebru Y Yalçınkaya, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gaziosmanpasa Taksim Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mehmet Akif GÜLER', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}