Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06129227
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Activity Changes After Structured Cognitive-motor Exercise for People With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This will be a single-blinded RCT. 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': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-10', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-11-10', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Single-task walking speed', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '10-meter walking test will be used to assess single-task walking speed in meters per second'}, {'measure': 'Balance 1', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Mini Balance Evaluation Systems Test will be used to assess postural control, with total points from 0-28. Higher points indicate better performance.'}, {'measure': 'Balance 2', 'timeFrame': 'Through study completion, an average of 1 year', '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': 'Cognitive performance', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Stroop color word test will be used to assess executive function'}, {'measure': 'Cognitive performance 1', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Digit Span Test will be used to assess working memory'}, {'measure': 'Cognitive performance 2', 'timeFrame': 'Through study completion, an average of 1 year', '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': 'Through study completion, an average of 1 year', 'description': 'Monthly telephone interviews for recording fall incidence'}], 'primaryOutcomes': [{'measure': 'Dual-task gait speed', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Gait speed under dual-task condition will be recorded'}, {'measure': 'Dual-task cognitive performance', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of correct responses will be measured during dual-task walking'}], 'secondaryOutcomes': [{'measure': 'Dual-task gait performance 1', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Gait cadence will be measured during dual-task walking'}, {'measure': 'Dual-task gait performance 2', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Stride length will be measured during dual-task walking'}, {'measure': 'Dual-task gait performance 3', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Trunk stability will be measured during dual-task walking'}, {'measure': 'Oxyhemoglobin concentration changes of the brain', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Oxyhemoglobin concentration changes will be measured using functional near infra-red spectroscopy during dual-task walking'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual-task training', 'Cognitive-motor interference'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'To assess the effects of a dual-task exercise program on cognitive-motor interference during dual-task walking and the associated changes in brain activity.', 'detailedDescription': 'Stroke is one of the leading causes of chronic disability in Hong Kong and other parts of the world. Mobility dysfunctions are among the most common impairments observed after stroke. Restoration of mobility is also a top priority in rehabilitation goal-setting by stroke patients. In daily life, functional ambulation in the community requires the ability to maintain walking balance while simultaneously engaging in other attention-demanding tasks (i.e., dual-tasking), such as walking when holding a conversation, or crossing the street while attending to traffic signals. There is increasing evidence that performing a cognitive task in conjunction with a mobility task would cause more severe degradation of one or both tasks among stroke patients when compared with age-matched able-bodied individuals. This phenomenon, termed "cognitive-motor interference", should warrant detailed study, since it has an important impact on community-living among people with stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of stroke confirmed by brain scan reports\n* Community-living\n* Stroke onset ≥ 6 months\n* Aged 50 years or older\n* Modified Rankin scale 1-3\n* Capable of following verbal instructions\n* Montreal Cognitive Assessment score ≥ 22\n* Ability to walk for 1 min independently with or without a walking aid\n* Not receiving formal rehabilitation elsewhere\n\nExclusion Criteria:\n\n* Other neurological disorders\n* Pain or other comorbidities that seriously affect the ability to walk\n* Contraindications to exercise (e.g., angina).'}, 'identificationModule': {'nctId': 'NCT06129227', 'briefTitle': 'Brain Activity Changes After Structured Cognitive-motor Exercise for People With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Using Functional Near-infrared Spectroscopy to Study the Changes in Brain Activity During Dual-task Walking and the Effects of Structured Cognitive-motor Exercise in Individuals With Stroke', 'orgStudyIdInfo': {'id': 'P0037680'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dual-task training', 'description': 'Mobility tasks performed in conjunction with cognitive tasks', 'interventionNames': ['Behavioral: Dual-task training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single-task training', 'description': 'Separate cognitive and mobility exercises', 'interventionNames': ['Behavioral: Single-task training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Upper limb strengthening and flexibility exercises', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'Dual-task training', 'type': 'BEHAVIORAL', 'description': 'This group will receive 30 min of dual-task exercise training and 30 min of stretching exercises in each session. The dual-task component involves walking activities performed in conjunction with cognitive activities. For the stretching exercise component, no cognitive load will be added.', 'armGroupLabels': ['Dual-task training']}, {'name': 'Single-task training', 'type': 'BEHAVIORAL', 'description': 'This group will undergo 30 min of single-task mobility training and another 30 min of single-task cognitive activities. The cognitive and mobility exercises will be the same as those in the dual-task group, but they will be performed separately. No extra cognitive load will be imposed during the mobility exercises. No additional motor demand will be imposed during the cognitive exercises, as the participants will be sitting.', 'armGroupLabels': ['Single-task training']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'This group will undergo 30 min of stretching exercises (same as the dual-task group) and another 30 min of upper limb strengthening exercises performed primarily in the sitting or lying position. No cognitive load will be added.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000', 'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Marco Yiu Chung PANG, PhD', 'role': 'CONTACT', 'email': 'Marco.Pang@polyu.edu.hk', 'phone': '2766-7156', 'phoneExt': '2766-7156'}], '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': '2766-7156', 'phoneExt': '2766-7156'}], 'overallOfficials': [{'name': 'Marco Yiu Chung PANG, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}, {'name': 'Xun LI, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'From Dec 2025 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'}, 'collaborators': [{'name': 'Research Grants Council, Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair professor', 'investigatorFullName': 'Marco Yiu-Chung Pang', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}