Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06362512
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Single-task walking speed', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': '10-meter walking test will be used to assess single-task walking speed in meters per second'}, {'measure': 'Dual-task walking performance', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': '1 min Forward Walking with Serial 3 subtractions will be used to assess motor and cognitive performance during dual-task walking.'}, {'measure': 'Mini Balance Evaluation Systems Test', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Mini Balance Evaluation Systems Test will be used to assess postural control and balance, with total points from 0-28. Higher points indicate better performance.'}, {'measure': 'Activities-specific Balance Confidence Scale', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Activities-specific Balance Confidence Scale will be used to assess confidence of functional balance performance, with total points from 0-100. Higher points indicate better performance.'}, {'measure': 'Trail Making Test', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Trail Making Test will be used to assess executive function'}, {'measure': 'Digit Span Test', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Digit Span Test will be used to assess working memory'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Montreal Cognitive Assessment will be used to assess global cognition, with total points from 0-30. Higher points indicate better performance.'}, {'measure': 'Fall incidence', 'timeFrame': 'before the initiation of training, 6 months after training', 'description': 'Monthly telephone interviews for recording fall incidence'}, {'measure': 'Dual-task ankle movement degree', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Ankle movement degree under dual-task condition will be recorded'}, {'measure': 'Dual-task cognitive performance time', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Time of correct responses under dual-task condition will be measured during dual-task conditions'}], 'primaryOutcomes': [{'measure': 'Dual-task step frequency', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'step frequency under dual-task condition will be recorded'}, {'measure': 'Dual-task cognitive performance accuracy', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Number of correct responses will be measured during dual-task conditions'}], 'secondaryOutcomes': [{'measure': 'Blood oxygenation level changes of the brain', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Blood oxygenation level changes will be measured using Magnetic Resonance Imaging during dual-task conditions'}, {'measure': 'Dual-task No.steps', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'No.steps under dual-task condition will be recorded'}, {'measure': 'Dual-task correct reaction time', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Correct reaction time under dual-task condition will be recorded'}, {'measure': 'Dual-task amplitude of ankle movement', 'timeFrame': 'before the initiation of training,after 6 weeks of training, 6 weeks after termination of the training', 'description': 'Amplitude of ankle movement under dual-task condition will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual-task training', 'Cognitive-motor interference'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity.', 'detailedDescription': 'The prevalence rate of stroke increased by 106.0% (93.7-118.8) from 1990 to 2019 in China, and stroke burden is still severe. Community ambulation is an important factor that influences health-related quality of life after a stroke.In daily living, effective community ambulation requires the ability to maintain balance and walking function while engaging in other tasks that demand attentional resources simultaneously (i.e., dual-tasking). Increasing evidence has shown that stroke patients have more problems with dual-task balance and walking function than their age-matched able-bodied peers. stroke individuals were found to have more reduction in both the walking speed and cognitive recall than control group during walking with remembering a shopping list. Hence, since stroke victims must reintegrate into community, this kind of cognitive-motor interference needs to be thoroughly studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nClinical diagnosis of stroke, Stroke onset of more than 6 months Aged 50 or more Capable of following verbal instructions Having a Montreal Cognitive Assessment score≥22, Able to walk for 1 minute without physical assistance Not receiving any formal rehabilitation training Having a Fugl-Meyer Ankle dorsiflexion-standing position score≥1\n\nExclusion Criteria\n\nContraindications to exercise (e.g., unstable angina) Contraindications to MRI (e.g., pacemaker) Color blindness Neurological disorders Gait-precluding pain Comorbidity'}, 'identificationModule': {'nctId': 'NCT06362512', 'acronym': 'COGMOTION', 'briefTitle': 'Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes.', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'An Innovative Cognitive-motor Exercise Training (COGMOTION) for People With Stroke: Effects on Balance, Mobility, Falls, Cognition and Related Brain Changes.', 'orgStudyIdInfo': {'id': 'Marco_PANG_2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dual-task group', 'description': 'patients receive three dual motor-cognitive exercise training per week for six weeks.', 'interventionNames': ['Behavioral: Dual-task training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single-task group', 'description': 'Patients receive three separate cognitive and mobility exercises per week for six weeks.', 'interventionNames': ['Behavioral: Single-task training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Patients receive three upper limb muscle strengthening exercise with muscle stretching per week for six weeks.', 'interventionNames': ['Behavioral: Upper limb strengthening exercise']}], 'interventions': [{'name': 'Dual-task training', 'type': 'BEHAVIORAL', 'description': 'participants receive three 60-minute COGMOTION dual-task exercise sessions per week for six consecutive weeks.', 'armGroupLabels': ['dual-task group']}, {'name': 'Single-task training', 'type': 'BEHAVIORAL', 'description': 'participants receive 30-minute single motor tasks with 30-minute single cognitive tasks three times per week for six consecutive weeks.The cognitive and mobility exercises will be the same as those in the dual-task group, but they will be performed separately.', 'armGroupLabels': ['single-task group']}, {'name': 'Upper limb strengthening exercise', 'type': 'BEHAVIORAL', 'description': 'participants receive upper limb strengthening exercise for 30 minutes and flexibility exercises for 30 minutes three times per week for six consecutive weeks. The training is performed in sitting or standing position and no cognitive load will be added.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Marco Yiu Chung Pang, PhD', 'role': 'CONTACT'}], 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Marco Yiu Chung PANG, PhD', 'role': 'CONTACT', 'email': 'Marco.Pang@polyu.edu.hk', 'phone': '+852 2766-7156', 'phoneExt': '2766-7156'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'From Dec 2026 onwards', 'ipdSharing': 'YES', 'description': 'The study data can be provided via contacting the Principal Investigator', 'accessCriteria': 'By contacting the Principal Investigator (Prof. Marco PANG): Marco.Pang@polyu.edu.hk'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}