Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-29 @ 12:57 AM
Study NCT ID:
NCT04982003
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Whole-body Drumming Classes for People With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single group, pre- post-test design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-07-19', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Step Cadence Variability', 'timeFrame': 'within 7 days before the intervention', 'description': 'Variability (SD) of step cadence'}, {'measure': 'Step Cadence Variability', 'timeFrame': 'within 7 days after intervention', 'description': 'Variability (SD) of step cadence'}, {'measure': 'Step Cadence Variability', 'timeFrame': '1-month following intervention', 'description': 'Variability (SD) of step cadence'}, {'measure': 'Stride Length Variability', 'timeFrame': 'within 7 days before the intervention', 'description': 'Variability (SD) of stride length'}, {'measure': 'Stride Length Variability', 'timeFrame': 'within 7 days after intervention', 'description': 'Variability (SD) of stride length'}, {'measure': 'Stride Length Variability', 'timeFrame': '1-month following intervention', 'description': 'Variability (SD) of stride length'}, {'measure': 'Change in repeated finger-tapping', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in inter-tapping intervals (ms) change from pre- to post-intervention'}, {'measure': 'Change in repeated finger-tapping', 'timeFrame': 'within 7 days before the intervention and 1-month following end of intervention', 'description': 'change in inter-tapping intervals (ms) change from pre- to 1-month following end of intervention'}], 'secondaryOutcomes': [{'measure': 'Change in Nine-hole peg test (NHP) duration (s)', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in speed of manual dexterity (s on NHP) from pre- to post-intervention'}, {'measure': 'Change in Nine-hole peg test (NHP) duration (s)', 'timeFrame': 'within 7 days before the intervention, and 1-month following intervention', 'description': 'change in speed of manual dexterity (s on NHP) from pre- to 1-month following end of intervention'}, {'measure': 'Change in Physical Performance Test (PPT) score', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to post-intervention.'}, {'measure': 'Change in Physical Performance Test (PPT) score', 'timeFrame': 'within 7 days before the intervention, and 1-month following intervention', 'description': 'change in whole-body functional mobility (PPT score; 0-36; higher is better) from pre- to 1-month following end of intervention'}, {'measure': 'Change in Parkinson Disease Questionnaire (PDQ-39)', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in disease-related quality of life (PDQ-39 score; 0-100, lower is better with improved quality of life) from pre- to post-intervention'}, {'measure': 'Change in Parkinson Disease Questionnaire (PDQ-39)', 'timeFrame': 'within 7 days before the intervention, and 1-month following intervention', 'description': 'change in disease-related quality of life (PDQ-39 score; 0-100, lower is better with improved quality of life) from pre- to 1-month following end of intervention'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to post-intervention'}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'within 7 days before the intervention, and 1-month following intervention', 'description': 'change in depression (GDS score; 0-15, higher is worse with more depression) from pre- to 1-month following end of intervention'}, {'measure': 'General Self-Efficacy scale (GSE)', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to post-intervention'}, {'measure': 'General Self-Efficacy scale (GSE)', 'timeFrame': 'within 7 days before the intervention, and 1-month following intervention', 'description': 'change in self-efficacy (GSE score; 10-40, higher is better with more self-efficacy) from pre- to 1-month following end of intervention'}, {'measure': 'Lille Apathy Rating Scale (LARS)', 'timeFrame': 'within 7 days before the intervention and within 7 days after intervention', 'description': 'change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to post-intervention'}, {'measure': 'Lille Apathy Rating Scale (LARS)', 'timeFrame': 'within 7 days before the intervention, and 1-month following intervention', 'description': 'change in apathy (LARS score; -36 to +36, lower is better with less apathy) from pre- to 1-month following end of intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "People with Parkinson's disease (PD) experience difficulty with gait, postural instability, and lack of movement coordination and rhythmic timing. Non-motor functions affected by PD include time perception, feelings of apathy, depression, decreased self-efficacy, and decrease self-reported quality of life. There is currently a lack of information on how a therapeutic drumming class that uses whole-body large-amplitude movements to music would impact these motor and non-motor impairments in individuals with PD. The primary purpose of this study is to assess the feasibility of a 10-week whole-body drumming class to music specifically selected for its rhythmic structure, and effects on movement rhythm and time perception in individuals with PD. The secondary purpose is to assess the effects of the drumming class on apathy, depression, self-efficacy and health-related quality of life. Participants will be included if they have a diagnosis of PD and are able to move for an hour with rests, either standing or seated. Participants are tested before and after the class series and one month following."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with PD\n* independent walking short community and household distances with or without assistive device\n* able to participate in a 1-hour class once a week for ten weeks\n\nExclusion Criteria:\n\n* change of Parkinson\'s medication or deep brain stimulation parameters within 2 weeks prior to or during the study\n* inability to grasp 2-inch diameter "drum sticks"\n* any conditions with contraindications to lift upper extremities overhead\n* any medical restrictions to exercise'}, 'identificationModule': {'nctId': 'NCT04982003', 'briefTitle': "Feasibility of Whole-body Drumming Classes for People With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'A.T. Still University of Health Sciences'}, 'officialTitle': "Feasibility and Effects of Whole-body Drumming Classes on Walking in People With Parkinson's Disease: a Pilot Study", 'orgStudyIdInfo': {'id': '2019-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Group', 'description': 'A single group of subjects with pretest, posttest, and one-month follow-up testing relative to 10-week drumming exercise classes', 'interventionNames': ['Other: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'OTHER', 'description': '10 weekly hour-long classes of drumming to music using large-amplitude, whole-body movements', 'armGroupLabels': ['Single Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'A.T. Still University Arizona School of Health Sciences', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}], 'overallOfficials': [{'name': 'Tara L McIsaac, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.T. Still University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.T. Still University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tara McIsaac', 'investigatorAffiliation': 'A.T. Still University of Health Sciences'}}}}