Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT03298503
Status:
UNKNOWN
Last Update Posted:
2018-01-02
First Post:
2017-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Task-priority Effects on Postural-suprapostural Task in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-17', 'releaseDate': '2024-05-03'}], 'estimatedResultsFirstSubmitDate': '2024-05-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'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'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-29', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-09-26', 'lastUpdatePostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electroencephalography (EEG)', 'timeFrame': 'about 30 seconds for each trial, total about 30 minutes', 'description': 'to collect the brain activity (unit: uV)'}, {'measure': 'Electromyography (EMG)', 'timeFrame': 'about 30 seconds for each trial, total about 30 minutes', 'description': 'to collect the muscle activity (unit: mV)'}], 'secondaryOutcomes': [{'measure': 'Gait parameters (GAITRite)', 'timeFrame': 'about 30 seconds for each trial, total about 30 minutes', 'description': 'to know how the subjects walk during the trial'}, {'measure': 'Center of pressure (COP)', 'timeFrame': 'about 30 seconds for each trial, total about 30 minutes', 'description': 'to know how the subjects stand during the trial'}, {'measure': 'Tilting angle of inclinometer', 'timeFrame': 'about 30 seconds for each trial, total about 30 minutes', 'description': 'to know how the subjects perform the suprapostural task during the trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'posture balance', 'attention'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '25224677', 'type': 'BACKGROUND', 'citation': "Peterson DS, Fling BW, Mancini M, Cohen RG, Nutt JG, Horak FB. Dual-task interference and brain structural connectivity in people with Parkinson's disease who freeze. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):786-92. doi: 10.1136/jnnp-2014-308840. Epub 2014 Sep 15."}, {'pmid': '22135764', 'type': 'BACKGROUND', 'citation': "Kelly VE, Eusterbrock AJ, Shumway-Cook A. A review of dual-task walking deficits in people with Parkinson's disease: motor and cognitive contributions, mechanisms, and clinical implications. Parkinsons Dis. 2012;2012:918719. doi: 10.1155/2012/918719. Epub 2011 Oct 27."}, {'pmid': '9224435', 'type': 'BACKGROUND', 'citation': 'Shumway-Cook A, Woollacott M, Kerns KA, Baldwin M. The effects of two types of cognitive tasks on postural stability in older adults with and without a history of falls. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M232-40. doi: 10.1093/gerona/52a.4.m232.'}, {'pmid': '26678262', 'type': 'BACKGROUND', 'citation': "Beck EN, Ehgoetz Martens KA, Almeida QJ. Freezing of Gait in Parkinson's Disease: An Overload Problem? PLoS One. 2015 Dec 17;10(12):e0144986. doi: 10.1371/journal.pone.0144986. eCollection 2015."}, {'pmid': '15201038', 'type': 'BACKGROUND', 'citation': 'Mitra S, Fraizer EV. Effects of explicit sway-minimization on postural--suprapostural dual-task performance. Hum Mov Sci. 2004 Jun;23(1):1-20. doi: 10.1016/j.humov.2004.03.003.'}, {'pmid': '26762801', 'type': 'BACKGROUND', 'citation': "Vervoort G, Heremans E, Bengevoord A, Strouwen C, Nackaerts E, Vandenberghe W, Nieuwboer A. Dual-task-related neural connectivity changes in patients with Parkinson' disease. Neuroscience. 2016 Mar 11;317:36-46. doi: 10.1016/j.neuroscience.2015.12.056. Epub 2016 Jan 5."}, {'pmid': '26003448', 'type': 'BACKGROUND', 'citation': 'Knaepen K, Mierau A, Tellez HF, Lefeber D, Meeusen R. Temporal and spatial organization of gait-related electrocortical potentials. Neurosci Lett. 2015 Jul 10;599:75-80. doi: 10.1016/j.neulet.2015.05.036. Epub 2015 May 21.'}, {'pmid': '38457151', 'type': 'DERIVED', 'citation': "Huang CY, Chen YA, Wu RM, Hwang IS. Neural Oscillations and Functional Significances for Prioritizing Dual-Task Walking in Parkinson's Disease. J Parkinsons Dis. 2024;14(2):283-296. doi: 10.3233/JPD-230245."}, {'pmid': '32234414', 'type': 'DERIVED', 'citation': 'Hung YT, Chen LC, Wu RM, Huang CY. The Effects of Task Prioritization on Dual-Tasking Postural Control in Patients With Parkinson Disease Who Have Different Postural Impairments. Arch Phys Med Rehabil. 2020 Jul;101(7):1212-1219. doi: 10.1016/j.apmr.2020.02.014. Epub 2020 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'Postural-suprapostural task is defined as postural control takes place while at least one other concurrent task is being performed. In a postural-suprapostural task, appropriate prioritization of is necessary to achieve task goals and maintain postural stability. Therefore, regarding to impose task prioritization in a postural-suprapostural task, the optimal task-priority strategy for PD patients is still an issue of debate. With the uses of EEG, EMG and behavioral measures, the purpose of this project is to investigate the differences in performance quality and intrinsic neural mechanisms of a postural-suprapostural task for PD patients, by adopting posture-focus and suprapostural-focus strategies during standing and walking. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and suprapostural tasks with different task prioritization under standing and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking disturbances.', 'detailedDescription': 'Postural-suprapostural task is defined as postural control takes place while at least one other concurrent task is being performed. In a postural-suprapostural task, appropriate prioritization of is necessary to achieve task goals and maintain postural stability. Some studies support that a "posture-first" strategy is favored by patients with Parkinson disease (PD) in order to secure stance stability, but this comes at the cost of reduced suprapostural performance. In addition, overemphasizing on postural task might deteriorate automatic control of posture resulting in increased postural instability, and the best task-priority strategy might vary with balance ability of PD patients. Therefore, regarding to impose task prioritization in a postural-suprapostural task, the optimal task-priority strategy for PD patients is still an issue of debate. With the uses of EEG, EMG and behavioral measures, the purpose of this 2-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of a postural-suprapostural task for PD patients, by adopting posture-focus and suprapostural-focus strategies during standing and walking. In the first year, we will characterize task prioritization effect on reciprocity of a postural-suprapostural task, with a special focus on modulation of brain and muscle activity patterns in standing posture for early stage (modified H \\& Y: 1, 1.5 and 2) and moderate stage (modified H \\& Y: 2.5 and 3) PD patients. In the second year, the appropriate task prioritization, walking automaticity and power/connectivity of brain areas will be investigated in walking for PD patients with/without freezing of gait. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and suprapostural tasks with different task prioritization under standing and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking disturbances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "inclusion criteria:\n\n1. patients with Parkinson's Disease in H\\&Y stage from stage 1 to stage 3\n2. without other neurological disease with balance impairment\n3. can stand and walk without aids for at least 30 seconds\n\nexclusion criteria:\n\n1. Mini-Mental State Examination \\> 27\n2. Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) \\< 10\n3. Hamilton Depression Rating Scale (HAM-D) \\< 17\n4. pregnancy"}, 'identificationModule': {'nctId': 'NCT03298503', 'briefTitle': "Task-priority Effects on Postural-suprapostural Task in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': "Effects of Task Prioritization on Postural-suprapostural Task and Brain Activity in Parkinson's Disease With Different Balance Ability: During Standing and Walking", 'orgStudyIdInfo': {'id': '201701080RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'early stage or non-freezers PD', 'description': 'early stage defined as modified Hoehn and Yahr scale 1, 1.5 and 2, means that symptoms involved unilateral or bilateral without impairment of balance.\n\nnon-freezers defined as without freezing of gait, means that patients without transient inability to generate effective stepping.', 'interventionNames': ['Other: task-priority strategies']}, {'type': 'EXPERIMENTAL', 'label': 'moderate stage or freezers PD', 'description': 'moderate stage defined as modified Hoehn and Yahr scale 2.5 and 3, means that symptoms involved unilateral or bilateral without impairment of balance.\n\nfreezers defined as with freezing of gait, means that patients have transient inability to generate effective stepping.', 'interventionNames': ['Other: task-priority strategies']}], 'interventions': [{'name': 'task-priority strategies', 'type': 'OTHER', 'description': 'posture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on postural task (standing/walking).\n\nsupraposture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on suprapostural task (stabilize the tray).', 'armGroupLabels': ['early stage or non-freezers PD', 'moderate stage or freezers PD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10048', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Cheng-Ya Huang, Ph.D.', 'role': 'CONTACT', 'email': 'rcyhuang@ntu.edu.tw', 'phone': '+886-3366-8131'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Cheng-Ya Huang, Ph.D.', 'role': 'CONTACT', 'email': 'rcyhuang@ntu.edu.tw', 'phone': '+886-3366-8131'}, {'name': 'Fu-Chang Tsai, Ph.D.', 'role': 'CONTACT', 'email': 'fctsai@ntu.edu.tw', 'phone': '+886-2312-3456', 'phoneExt': '88576'}], 'overallOfficials': [{'name': 'Cheng-Ya Huang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-05-03', 'type': 'RELEASE'}, {'date': '2024-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'National Taiwan University Hospital'}}}}