Viewing Study NCT00121693


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Study NCT ID: NCT00121693
Status: COMPLETED
Last Update Posted: 2016-01-27
First Post: 2005-07-15
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: The Use of Music Therapy in the Prevention of Falls
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 266}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2005-07-15', 'studyFirstSubmitQcDate': '2005-07-20', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pretest and posttest scores will be collected for ten treatment conditions at three post-treatment times (10 minutes, 1 week, and 1 month)', 'timeFrame': 'Immediate pre and post balance testing', 'description': 'balance testing before and after listening to music'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fall prevention', 'posturography', 'music therapy'], 'conditions': ['Accidental Falls', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '17604555', 'type': 'BACKGROUND', 'citation': 'Carrick FR, Oggero E, Pagnacco G. Posturographic changes associated with music listening. J Altern Complement Med. 2007 Jun;13(5):519-26. doi: 10.1089/acm.2007.7020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether listening to music will demonstrate changes in human postural stability and whether those changes might be useful in fall prevention strategies.', 'detailedDescription': "Falls are a serious health issue and are the greatest cause of death in the elderly. The use of music therapy in fall prevention has not been reported in the literature. This investigation will provide experimental support to the assumption that music therapy may prevent falls and that certain music can affect increases in postural stability using randomly selected subjects, validated posturography and a full experimental design.\n\nComputer dynamic posturography (CDP) tests will provide stability scores in volunteer subjects who have had no previous history of falls or vertigo. Subjects will be randomized into several different music listening groups and one control group. Examiners will be blinded as to the music listened to and the outcome measurements. Subjects will be blinded as to their posturographic measurements. The music listening groups will be given a daily specific music listening task. CDP tests will be obtained 10 minutes, 1 week and 1 month after subject's treatment. Music selection will include Mozart, Nolwenn Leroy and others suggested to change human stability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No history of previous fall(s) or dizziness\n\nExclusion Criteria:\n\n* History of previous fall(s) or dizziness'}, 'identificationModule': {'nctId': 'NCT00121693', 'briefTitle': 'The Use of Music Therapy in the Prevention of Falls', 'organization': {'class': 'OTHER', 'fullName': 'Carrick Institute for Graduate Studies'}, 'officialTitle': 'Posturographic Changes Associated With Music Therapy and Fall Prevention', 'orgStudyIdInfo': {'id': 'CI-01-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music Listening 1', 'description': 'Intervention: Listen to Music type 1', 'interventionNames': ['Behavioral: Music therapy (listening to specific music)']}, {'type': 'EXPERIMENTAL', 'label': 'Music Listening 2', 'description': 'Intervention: Listen to Music type 2', 'interventionNames': ['Behavioral: Music therapy (listening to specific music)']}, {'type': 'EXPERIMENTAL', 'label': 'Music LIstening 3', 'description': 'Intervention: Listen to Music type 3', 'interventionNames': ['Behavioral: Music therapy (listening to specific music)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Intervention: Listen to White noise'}], 'interventions': [{'name': 'Music therapy (listening to specific music)', 'type': 'BEHAVIORAL', 'description': 'Listening to Music', 'armGroupLabels': ['Music LIstening 3', 'Music Listening 1', 'Music Listening 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32920', 'city': 'Cape Canaveral', 'state': 'Florida', 'country': 'United States', 'facility': 'Carrick Institute for Graduate Studies', 'geoPoint': {'lat': 28.40584, 'lon': -80.60477}}], 'overallOfficials': [{'name': 'Frederick R Carrick, PhD, FACCN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Carrick Institute for Graduate Studies'}, {'name': 'Elena Ogerro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carrick Institute for Graduate Studies'}, {'name': 'Guido Pagnacco, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carrick Institute for Graduate Studies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carrick Institute for Graduate Studies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Frederick Carrick, PhD, FACCN', 'investigatorAffiliation': 'Carrick Institute for Graduate Studies'}}}}