Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-04 @ 9:46 PM
Study NCT ID:
NCT06000904
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategy of Turning Performance in Individuals 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-13', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turning velocity (degrees/second)', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Number of steps taken during turning', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Turning step length (cm)', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Stance phase duration (%) during turning', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Swing phase duration (%) during turning', 'timeFrame': 'Change from baseline at 4 weeks'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'The Berg Balance Scale is employed to evaluate the functional balance ability of the subjects. This tool comprises 14 individual tests, each scored on a scale from 0 to 4, resulting in a total score of 56. A higher score indicates better balance ability.'}, {'measure': 'Limits of stability test', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'The limits of stability test is used to evaluate the dynamic balance ability of participants. Overall percentage is defined as the amount of direction control accuracy the individual has when performing the test. A higher percentage reflects better performance.'}, {'measure': 'Modified clinical test of sensory interaction in balance', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'This test is designed to assess sensory integration ability basing on the conditions of eyes open or closed and stable or unstable ground. The test is conducted in four contexts: context 1 involves standing with eyes open on a firm surface; context 2 involves standing with eyes open on a foam cushion; context 3 involves standing with eyes closed on a firm surface; and context 4 involves standing with eyes closed on a foam cushion. The overall sway index will be recorded for each condition of each trial, which will be summed the average of each condition.'}, {'measure': 'Walking velocity (cm/sec) in straight walk', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Step length (cm) in straight walk', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Cadence (steps/minute) in straight walk', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Stance phase duration (%) in straight walk', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Swing phase duration (%) in straight walk', 'timeFrame': 'Change from baseline at 4 weeks'}, {'measure': 'Time Up and Go test', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'The Timed Up \\& Go (TUG) test is employed to evaluate the activity functionality of participants. The average time taken for completion will be recorded for analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Turning performance', 'Balance performance', 'Exergame', 'Balance training', 'Stroke'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This is a single-blind randomized controlled trial study. Thirty individuals with chronic stroke will be recruited and randomly assigned to the experimental and control groups. Subjects in the experimental group will receive exergame-based balance training, while subjects in the control group will receive upper limb and trunk training. Both groups will undergo a four-week intervention consisting of three sessions per week, each lasting 60 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged ≥18 years\n* single incident of stroke\n* stroke duration of at least 6 months\n* lower limb Brunnstrom motor recovery stage between level three and five\n* Functional Ambulation Categories scale ≥3\n\nExclusion Criteria:\n\n* Individuals with cognitive impairmen (the Mini-Mental State Examination with a score below 24)\n* visual or auditory impairments\n* communication disorders\n* other neurological diseases affecting motor performance, or any orthopedic conditions that could influence walking ability\n* contraindications to physical activity, such as angina or uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT06000904', 'briefTitle': 'Strategy of Turning Performance in Individuals With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Evaluation and Improving Strategy of Turning Performance in Individuals With Stroke', 'orgStudyIdInfo': {'id': 'NYCU112118AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exergame-based balance training group', 'interventionNames': ['Other: Exergame-based balance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Upper limb and trunk training group', 'interventionNames': ['Other: Upper limb and trunk training']}], 'interventions': [{'name': 'Exergame-based balance training', 'type': 'OTHER', 'description': 'For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute balance exercise, and 15-minute ground walking as a cool-down.', 'armGroupLabels': ['Exergame-based balance training group']}, {'name': 'Upper limb and trunk training', 'type': 'OTHER', 'description': 'For a four-week intervention consisting of three weekly sessions, each lasting 60 minutes. Each training session will include a 5-minute warm-up activity, 40-minute upper-limb and trunk exercise, and 15-minute ground walking as a cool-down.', 'armGroupLabels': ['Upper limb and trunk training group']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}