Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-28 @ 10:57 AM
Study NCT ID:
NCT07078903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Impairment and Gait Balance in Chronic Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2025-07-14', 'studyFirstSubmitQcDate': '2025-07-14', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between IQCODE scores and center of pressure velocity (eyes open)', 'timeFrame': 'At baseline (single session)', 'description': 'Assess the relationship between cognitive impairment and balance control by comparing IQCODE scores with center of pressure velocity during quiet standing with eyes open.'}], 'secondaryOutcomes': [{'measure': 'Correlation between IQCODE scores and center of pressure velocity (eyes closed)', 'timeFrame': 'At baseline (single session)', 'description': 'Assess the relationship between cognitive impairment and postural control by comparing IQCODE scores with center of pressure velocity during quiet standing with eyes closed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Impairment', 'Chronic Stroke', 'Gait Balance'], 'conditions': ['Chronic Stroke Patients']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the relationship between cognitive impairment and gait balance in individuals with chronic stroke. Using the IQCODE and a balance assessment system, the study evaluates how post-stroke cognitive decline may influence stability and motor control. The findings will support better rehabilitation strategies tailored to cognitive function.', 'detailedDescription': 'Cognitive and motor impairments are common consequences of stroke, but they are often treated separately. A growing body of evidence suggests a potential link between cognitive function and physical performance, including balance and gait. This prospective, cross-sectional study investigates the relationship between post-stroke cognitive impairment and gait balance in chronic stroke survivors. Participants will undergo cognitive evaluation using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), and gait balance will be assessed through center of pressure velocity with eyes open and closed. The goal is to identify whether cognitive decline is associated with impaired balance performance and to explore the influence of age, stroke type, and duration on these outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A non-random sample of 26 adults aged 25-75 years with chronic stroke, recruited from outpatient rehabilitation centers. Participants were assessed in a single session to evaluate the relationship between cognitive impairment and gait balance.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 25-75 years\n* Diagnosed with chronic stroke (≥6 months post-stroke)\n* Able to stand independently for testing\n* Capable of completing assessments or has an informant available for IQCODE\n\nExclusion Criteria:\n\n* Severe visual, vestibular, or musculoskeletal impairments\n* History of other neurological disorders\n* Acute illness or uncontrolled medical condition\n* Inability to follow instructions or complete cognitive/balance assessments'}, 'identificationModule': {'nctId': 'NCT07078903', 'briefTitle': 'Cognitive Impairment and Gait Balance in Chronic Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Relationship Between Cognitive Impairment and Gait Balance in Chronic Stroke Survivors: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'MUREC-March.17/COM-2021/30-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Stroke Survivors', 'description': 'A group of 26 adults with chronic stroke will be assessed to examine the relationship between cognitive impairment and gait balance. Cognitive function will be evaluated using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), and balance will be assessed using center of pressure measurements with eyes open and closed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Your dataset is small, with identifiable clinical information, which raises privacy and ethical concerns.\n\nThere\'s no formal plan in place for anonymized data sharing.\n\nMost ICMJE-compliant journals accept a "No" or "Undecided" answer, especially for observational studies that do not involve public databases.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Islam Hassan Fayed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Majmaah University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Assistan Professor', 'investigatorFullName': 'Islam Hassan Fayed', 'investigatorAffiliation': 'Cairo University'}}}}