Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-28 @ 2:06 PM
Study NCT ID:
NCT07086092
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Serum Markers and Motor Recovery and Ambulation in Post-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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014527', 'term': 'Uric Acid'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum magnesium levels', 'timeFrame': 'Before treatment', 'description': "Serum magnesium levels measured before the patients' rehabilitation will be obtained from past medical records."}, {'measure': 'Serum uric acid levels', 'timeFrame': 'Before treatment', 'description': "Serum uric acid levels measured before the patients' rehabilitation will be obtained from past medical records."}, {'measure': 'Serum vitamin D levels', 'timeFrame': 'Before treatment', 'description': "Serum vitamin D levels measured before the patients' rehabilitation will be obtained from past medical records."}, {'measure': 'Brunnstrom Motor Recovery Stage', 'timeFrame': 'Before treatment', 'description': "Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery. Brunnstrom Motor Recovery Stages measured before the patients' rehabilitation will be obtained from past medical records."}, {'measure': 'Functional Ambulation Classification', 'timeFrame': 'Before treatment', 'description': "Functional Ambulation Classification is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface. Functional Ambulation Classification Stages measured before the patients' rehabilitation will be obtained from past medical records."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Biomarkers', 'Serum Magnesium', 'Serum Vitamin D', 'Serum Uric Acid']}, 'descriptionModule': {'briefSummary': 'This study aim to retrospectively investigate the effects of the magnesium, vitamin D, and uric acid serum markers on motor recovery and ambulation in post-stroke patients.', 'detailedDescription': 'Stroke is the sudden loss of neurological function associated with a reduction or cessation of blood flow in the brain, resulting from the blockage or rupture of cerebral vessels. Stroke is the second leading cause of death and the third leading cause of disability worldwide. Regaining motor recovery and ambulation skills in patients is one of the main goals of rehabilitation. It is critical for patients to improve their quality of life and regain their independence. Serum biochemical markers can be used to predict post-stroke recovery. Serum magnesium, vitamin D, and uric acid are biochemical markers that may play a role in the recovery process of stroke patients.\n\nThis study aim to retrospectively investigate the effects of the magnesium, vitamin D, and uric acid serum markers on motor recovery and ambulation in post-stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had a stroke for the first time and are hospitalized in the rehabilitation ward for rehabilitation purposes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had a single stroke between 2019 and 2024\n* Patients who were admitted to the rehabilitation ward and had their serum vitamin D, magnesium, and uric acid levels measured\n* Patients whose functional ambulation scale scores and Brunnstrom motor recovery stages were recorded\n\nExclusion Criteria:\n\n* Patients with other neurological diseases\n* Patients with multiple strokes\n* Patients with gout, renal failure, or hyperparathyroidism'}, 'identificationModule': {'nctId': 'NCT07086092', 'briefTitle': 'Relationship Between Serum Markers and Motor Recovery and Ambulation in Post-stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Relationship Between Serum Markers and Motor Recovery and Ambulation in Post-stroke Patients: a Retrospective Analysis', 'orgStudyIdInfo': {'id': 'AIBU-FTR-SK-11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Serum magnesium, uric acid, and vitamin D levels and motor recovery and ambulation stages', 'type': 'OTHER', 'description': "Serum magnesium, uric acid, and vitamin D levels, as well as motor recovery and ambulation levels, measured during the patients' rehabilitation stay will be obtained from past medical records."}]}, 'contactsLocationsModule': {'locations': [{'zip': '14100', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Abant Izzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Serdar Kilinc', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}