Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT05906693
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Quality of Life in Individuals With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D014202', 'term': 'Tremor'}], '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'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}, {'id': 'D018737', 'term': 'Hand Strength'}, {'id': 'D052581', 'term': 'Pinch Strength'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D053580', 'term': 'Muscle Strength'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-13', 'size': 80280, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-07T08:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-06-07', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale", 'timeFrame': '1 year', 'description': "The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale. Used for the evaluation of clinical manifestations of Parkinson's disease. The scale consists of 4 subscales: the first part is Non-Motor Aspects of Experiences of Daily Living (13), the second part is Motor Aspects of Experiences of Daily Living (13), the third part is Motor Examination (33), and the fourth part is Motor Complications (6). The total number of items in the scale is 65. The minimum score is 0. The maximum MDS-UPDRS score is higher, given the additional items and scores for each body area, with a maximum score of 272. Higher scores indicate greater impact of Parkinson Disease symptoms."}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '1 year', 'description': 'The Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression and consists of 14 items, seven items for the anxiety subscale (Hospital Anxiety and Depression Scale Anxiety) and seven for the depression subscale (Hospital Anxiety and Depression Scale Depression). Each item is scored on a response-scale with four alternatives ranging between 0 and 3. After adjusting for six items that are reversed scored, all responses are summed to obtain the two subscales. Both depression and anxiety subheadings are scored between 0 and 21. Higher scores indicate greater levels of anxiety or depression. Cut-off scores are 8-10 for doubtful cases and ≥11 for definite cases.'}, {'measure': "Parkinson's Disease Quality of Life Questionnaire (PDQ-39)", 'timeFrame': '1 year', 'description': "Used to assess the quality of life of Parkinson's patients"}, {'measure': 'Electromyography', 'timeFrame': '1 year', 'description': "Used to assess the tremor amplitude of Parkinson's patients"}, {'measure': 'Nine-Hole Peg Test', 'timeFrame': '1 year', 'description': "Used to assess the upper limb functionality of Parkinson's patients"}, {'measure': 'Dynamometer', 'timeFrame': '1 year', 'description': "Used to assess the grip and pinch strength of Parkinson's patients"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Upper Limb Functionality', 'Tremor', 'Electromyography', "Parkinson's Disease"], 'conditions': ['Parkinson Disease', 'Tremor', 'Functionality']}, 'referencesModule': {'references': [{'pmid': '31118162', 'type': 'BACKGROUND', 'citation': "Kuhlman GD, Flanigan JL, Sperling SA, Barrett MJ. Predictors of health-related quality of life in Parkinson's disease. Parkinsonism Relat Disord. 2019 Aug;65:86-90. doi: 10.1016/j.parkreldis.2019.05.009. Epub 2019 May 7."}, {'pmid': '29193359', 'type': 'BACKGROUND', 'citation': 'Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.'}, {'pmid': '25952960', 'type': 'BACKGROUND', 'citation': "Louis ED, Machado DG. Tremor-related quality of life: A comparison of essential tremor vs. Parkinson's disease patients. Parkinsonism Relat Disord. 2015 Jul;21(7):729-35. doi: 10.1016/j.parkreldis.2015.04.019. Epub 2015 Apr 24."}]}, 'descriptionModule': {'briefSummary': "This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. The differences between Parkinson's Disease Quality of Life Questionnaire, Nine-Hole Peg Test, grip and pinch strength values in the individuals with and without tremor in the study were investigated.", 'detailedDescription': "Evaluating the relationship between Quality of Life and tremor is needed to determine the best physiotherapy and rehabilitation approaches for individuals with Parkinson's Disease. This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. Fifty-two individuals with Parkinson's Disease participated in the study. Quality of Life, tremor amplitude, upper limb functionality, grip and pinch strength were evaluated. The relationship of quality of life with tremor severity and upper limb functionality was examined in individuals with Parkinson's Disease. The results of individuals with and without tremor were compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with Parkinson Disease were included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definite diagnosis of idiopathic Parkinson Disease\n* Age between 40 and 80 years\n* Being literate\n* Having a grade between 1-4 from the Modified Hoehn and Yahr Scale\n* Having a score lower than 11 in Hospital Anxiety and Depression Scale\n\nExclusion Criteria:\n\n* Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity\n* Using antidepressants\n* Having vision loss\n* Deep brain stimulation'}, 'identificationModule': {'nctId': 'NCT05906693', 'briefTitle': "The Quality of Life in Individuals With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': "A Cross-sectional Study - The Quality of Life in Individuals With Parkinson's Disease: Is it Related to Functionality and Tremor Severity?", 'orgStudyIdInfo': {'id': '60116787-020/45991'}, 'secondaryIdInfos': [{'id': '2019SABE021', 'type': 'OTHER_GRANT', 'domain': 'PAU Scientific Research Projects Coordination'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Quality of life', 'type': 'OTHER', 'description': "Parkinson's Disease Quality of Life Questionnaire (PDQ-39)"}, {'name': 'Upper limb functionality', 'type': 'OTHER', 'description': 'Nine-Hole Peg Test'}, {'name': 'Grip and pinch strength', 'type': 'OTHER', 'description': 'Dynamometer'}, {'name': 'Tremor amplitude', 'type': 'OTHER', 'description': 'Electromyography'}, {'name': 'Depression and anxiety levels', 'type': 'OTHER', 'description': 'Hospital Anxiety and Depression Scale'}, {'name': 'Clinical manifestations', 'type': 'OTHER', 'description': "The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale"}]}, 'contactsLocationsModule': {'locations': [{'zip': '20190', 'city': 'Denizli', 'state': 'Pamukkale', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Buse KILINÇ, PT.MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University'}, {'name': 'Nilüfer ÇETİŞLİ-KORKMAZ, PT.PhD.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}, {'name': 'Levent S. BIR, MD.PhD.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pamukkale University'}, {'name': 'Ahmet D. MARANGOZ, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinikum Stuttgart'}, {'name': 'Hande ŞENOL, Assist.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT.MSc.', 'investigatorFullName': 'Buse KILINÇ', 'investigatorAffiliation': 'Pamukkale University'}}}}