Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2026-02-13 @ 8:07 AM
Study NCT ID:
NCT04033393
Status:
UNKNOWN
Last Update Posted:
2019-07-29
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-task Performance in Young-onset PD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2019-07-24', 'studyFirstSubmitQcDate': '2019-07-24', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dual-task walking performance', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate gait parameters while doing dual-task walking'}], 'secondaryOutcomes': [{'measure': 'Single walking performance', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate gait parameters while doing single walking'}, {'measure': 'Timed up and go test', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate functional walking ability'}, {'measure': "Parkinson's Disease Questionnaire 39", 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate the quality of life'}, {'measure': 'Frontal lobe battery test-Chinese version', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Trail-making test', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Stroop color and word test-Chinese version', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Verbal fluency test-Chinese version', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Digit span test', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Dual-task costs', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To compare the cost between doing dual task and single task'}, {'measure': 'Functional near-infrared spectroscopy', 'timeFrame': 'Change from baseline at 8 weeks', 'description': 'To evaluate the changes of blood perfusion in frontal lobe'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Executive function', 'Dual-task performance', 'Dual-task training'], 'conditions': ['Early Onset Parkinson Disease', 'Early Stage Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as PD and Hoehn and Yahr stage between 1\\~3\n* Age between 20 to 80\n* Able to walk 10 m independently without an assistive device\n* A score of greater than or equal to 24 on the mini-mental state examination (MMSE)\n* In stable medical condition allowing participation in the testing protocol and intervention\n\nExclusion Criteria:\n\n* Any comorbidity or disability other than PD that would preclude gait training\n* Any uncontrolled health condition for which exercise was contraindicated\n* Any neurological or orthopedic disease that might interfere with the study\n* Server freezing of gait, FOG questionnaire \\> 15'}, 'identificationModule': {'nctId': 'NCT04033393', 'briefTitle': 'Dual-task Performance in Young-onset PD', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': "Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects", 'orgStudyIdInfo': {'id': '2019-05-005C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Game based dual-task training group', 'description': 'Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks', 'interventionNames': ['Other: Game based dual-task training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treadmill training group', 'description': 'Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks', 'interventionNames': ['Other: Treadmill training']}], 'interventions': [{'name': 'Game based dual-task training', 'type': 'OTHER', 'description': 'Participants in the experimental group will receive game based dual-task training with a treadmill', 'armGroupLabels': ['Game based dual-task training group']}, {'name': 'Treadmill training', 'type': 'OTHER', 'description': 'Participants in the control group will receive treadmill training', 'armGroupLabels': ['Treadmill training group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yang Yearu, Ph.D.', 'role': 'CONTACT', 'email': 'yryang@ym.edu.tw', 'phone': '+88628267279'}]}, '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'}}}}