Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-31 @ 4:35 PM
Study NCT ID:
NCT06840405
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical Activation During Walking in Stroke
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain activity', 'timeFrame': 'One-time measurement during a one-minute walking task at a single study visit', 'description': 'Using functional near infrared spectroscopy to measure the oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the bilateral prefrontal cortex, supplementary motor area and primary motor cortex.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Forward walking', 'Backward walking', 'Brain activity', 'Stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'After stroke, damage to one cerebral hemisphere disrupts the normal balance of activity between the two hemispheres. The affected hemisphere typically exhibits reduced excitability, whereas the unaffected side may demonstrate increased excitability. This phenomenon, referred to as interhemispheric imbalance, further inhibits activity in the affected hemisphere, thereby restricting motor recovery. According to the interhemispheric competition model, enhancing excitability in the affected hemisphere and/or suppressing excitability in the unaffected hemisphere may contribute to the improvement of motor function in individuals with stroke. Furthermore, as motor function recovers, the balance of interhemispheric activation in motor-related cortical areas undergoes corresponding changes. Previous studies have shown that treadmill training enhances the excitability of the primary motor cortex in both hemispheres of stroke patients, as well as increases excitability across multiple cortical and subcortical regions in both hemispheres. However, it remains unclear whether treadmill training can normalize the interhemispheric imbalance in stroke patients. Additionally, the effects of forward and backward walking on the activity of motor-related brain regions in individuals with stroke are still unclear. Therefore, this cross-sectional study aims to investigate the changes in motor-related brain activity during forward walking and backward walking in individuals with chronic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with chronic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 6 months after the diagnosis of stroke\n* Independent walking over at least 7m with or without a walking aid\n* Mini-mental state examination score ≥ 24\n\nExclusion Criteria:\n\n* Had difficulty in backward walking\n* Any neuromuscular disorders history\n* With visual or auditory disorders\n* Unstable cardiac status or uncontrolled hypertension\n* Any musculoskeletal disorders that would affect walking ability'}, 'identificationModule': {'nctId': 'NCT06840405', 'briefTitle': 'Cortical Activation During Walking in Stroke', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Cortical Activation During Forward and Backward Walking in Individuals With Chronic Stroke', 'orgStudyIdInfo': {'id': 'NYCU113210AF1'}}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yea-Ru Yang, PhD', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw', 'phone': '+886-2-2826-7279'}], 'facility': 'Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yea-Ru Yang, PhD', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw', 'phone': '+886228267279'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yea-Ru Yang', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}