Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT06191406
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2023-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Five-year Changes in Patients With Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000070857', 'term': 'Walk Test'}], 'ancestors': [{'id': 'D005080', 'term': 'Exercise Test'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2023-12-09', 'studyFirstSubmitQcDate': '2024-01-03', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk test', 'timeFrame': '5 years', 'description': 'walk distance covered over a time of 6 minutes'}, {'measure': '10-meter walk test', 'timeFrame': '5 years', 'description': 'comfortable \\& fast gait speed'}, {'measure': 'Thai MMSE', 'timeFrame': '5 years', 'description': "test patient's cognition with mini-mental state examination (MMSE) Minimum score = 0 (worst outcome, poor cognitive function) Maximum score = 30 (better outcome, good cognitive function)"}], 'secondaryOutcomes': [{'measure': 'Global quality of life', 'timeFrame': '5 years', 'description': 'Global quality of life questionnaire which the patient will give their own score of their quality of life, scale from 0-100 (0 = worst quality of life, 100 = best quality of life)'}, {'measure': 'Short FES-I', 'timeFrame': '5 years', 'description': 'the Short Falls Efficacy Scale International (Short FES-I) questionnaire Minimum score = 7 (better outcome, less fear of falling) Maximum score = 28 (worst outcome, most fear of falling)'}, {'measure': 'Fatigue assessment scale', 'timeFrame': '5 years', 'description': 'Fatigue assessment scale questionnaire Minimum score = 10 (better outcome, less fatigue) Maximum score = 50 (worst outcome, more fatigue)'}, {'measure': 'Barthel index', 'timeFrame': '5 years', 'description': 'Barthel index questionnaire Minimum score = 0 (worst outcome, mostly dependent in daily living) Maximum score = 100 (better outcome, independent in daily living)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Stroke']}, 'descriptionModule': {'briefSummary': 'Objective of the study:\n\n* To determine changes in physical and cognitive function in patients with chronic stroke over 5 years\n* To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study: Validity and Test-Retest Reliability of a Thai Stroke Physical Activity Questionnaire) which the population was stroke patients, aged ≥ 18 years with onset \\> 3 months. The study population is composed of patients who have achieved a compliance rate of more than 70% with the accelerometer within 1 week, total 50 people.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study)\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT06191406', 'briefTitle': 'Five-year Changes in Patients With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Five-year Changes in Physical and Cognitive Function in Patients With Chronic Stroke: a Preliminary Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'HE661406'}}, 'armsInterventionsModule': {'interventions': [{'name': '6 minute walk test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['10 meters walk test', 'Thai MMSE'], 'description': 'Test for physical functions and cognitive functions'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40001', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident in Physical medicine and rehabilitation department, Principal Investigator', 'investigatorFullName': 'Yanisa Sinthunyathum', 'investigatorAffiliation': 'Khon Kaen University'}}}}