Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT03927469
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2019-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000375', 'term': 'Aging'}, {'id': 'D012723', 'term': 'Sex'}, {'id': 'D012621', 'term': 'Seasons'}, {'id': 'C035000', 'term': 'CAF protocol'}], 'ancestors': [{'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D010507', 'term': 'Periodicity'}, {'id': 'D013995', 'term': 'Time'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D002980', 'term': 'Climate'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-04-24', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rehospitalisation rates', 'timeFrame': '3 YEARS', 'description': 'rehospitalisation rates. Data will given as percent'}], 'secondaryOutcomes': [{'measure': 'Serum vitamin D level', 'timeFrame': '3 YEARS', 'description': 'Serum 25 (OH) vitamin D level. Unit of this parameter is U/L'}, {'measure': 'Serum vitamin B12 level', 'timeFrame': '3 YEARS', 'description': 'Serum B12 level. Unit of this parameter is U/L'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '22389457', 'type': 'BACKGROUND', 'citation': 'Ottenbacher KJ, Graham JE, Ottenbacher AJ, Lee J, Al Snih S, Karmarkar A, Reistetter T, Ostir GV. Hospital readmission in persons with stroke following postacute inpatient rehabilitation. J Gerontol A Biol Sci Med Sci. 2012 Aug;67(8):875-81. doi: 10.1093/gerona/glr247. Epub 2012 Mar 2.'}, {'pmid': '24088308', 'type': 'BACKGROUND', 'citation': 'Sun Y, Lee SH, Heng BH, Chin VS. 5-year survival and rehospitalization due to stroke recurrence among patients with hemorrhagic or ischemic strokes in Singapore. BMC Neurol. 2013 Oct 3;13:133. doi: 10.1186/1471-2377-13-133.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.', 'detailedDescription': 'All comorbid diseases were included to rehospitalisation rates in stroke patients in the literature. The aim of this study was to investigate the clinical and laboratory data of patients who were rehospitalised due to "stroke rehabilitation cause only" The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.\n\nThere were 554 patients with these diagnoses. 9 patients of them were excluded because of the hemiplegic due to trauma, cancer and intracranial operation. Detailed epicrisis of 545 patients with ischemic or hemorrhagic stroke were examined. 328 patients who did not have missing data were included in the study. Age, sex, hemiplegia etiology, admission season, hemiplegia time, hemiplegic side, 25 (OH) vitamin D and vitamin B12 levels, brunnstrom stage of upper extremity, lower extremity and hand Functional Ambulation Classification (FAC).\n\nBrunnstrom staging was used to identify motor function with 6 levels in the upper extremity and hand. ROM for abduction, flexion, internal rotation, and external rotation were passively measured. Brunnstrom staging was used to evaluate motor development, and stroke patients were defined as 6 stages. The flask phase without the lowest voluntary movement is considered to be stage 1, while the presence of isolated movements is considered to be stage 6. In the Brunstromm staging, upper, lower extremity and hand evaluation are performed separately.\n\nFAC is defined as 5 stages according to the basic motor skills required for functional ambulation. FAC stage 0 is used for non-functional ambulation, stage 5 is used for independent walking at each speed and ground.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) were included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1)\n* Being ischemic or hemorrhagic stroke\n\nExclusion Criteria:\n\n* Being hemiplegic due to trauma, cancer and intracranial operation'}, 'identificationModule': {'nctId': 'NCT03927469', 'acronym': 'RSR', 'briefTitle': 'Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}, 'officialTitle': 'Analysis Of The Patients Who Need Rehospitalization Due To Stroke Rehabilitation Only', 'orgStudyIdInfo': {'id': 'IstPMRTRH-449'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalisation group', 'description': 'The patients who were hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.', 'interventionNames': ['Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)']}, {'label': 'Re-hospitalisation group.', 'description': 'The patients who were re-hospitalized in the hospital between January 2015 and July 2018, according to ICD 10 code; hemiplegia (G81), flaccid hemiplegia (G81.0), hemiplegia, unspecified (G81.9), Spastic hemiplegia (G81.1) scanned from the hospital database.', 'interventionNames': ['Other: age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)']}], 'interventions': [{'name': 'age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)', 'type': 'OTHER', 'otherNames': ['Corelation of data, FAC: Functional Ambulation Classification and age, stroke duration, Season, stroke Etiology, Brunnstrom, FAC'], 'description': 'This is a retrospiective descriptive study', 'armGroupLabels': ['Hospitalisation group', 'Re-hospitalisation group.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34192', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'TUGBA AYDIN', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tuğba Aydın', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}