- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00121693
The Use of Music Therapy in the Prevention of Falls
Posturographic Changes Associated With Music Therapy and Fall Prevention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Computer 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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Cape Canaveral, Florida, United States, 32920
- Carrick Institute for Graduate Studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- No history of previous fall(s) or dizziness
Exclusion Criteria:
- History of previous fall(s) or dizziness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Music Listening 1
Intervention: Listen to Music type 1
|
Listening to Music
|
Experimental: Music Listening 2
Intervention: Listen to Music type 2
|
Listening to Music
|
Experimental: Music LIstening 3
Intervention: Listen to Music type 3
|
Listening to Music
|
No Intervention: Control
Intervention: Listen to White noise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pretest and posttest scores will be collected for ten treatment conditions at three post-treatment times (10 minutes, 1 week, and 1 month)
Time Frame: Immediate pre and post balance testing
|
balance testing before and after listening to music
|
Immediate pre and post balance testing
|
Collaborators and Investigators
Investigators
- Principal Investigator: Elena Ogerro, PhD, Carrick Institute for Graduate Studies
- Principal Investigator: Guido Pagnacco, PhD, Carrick Institute for Graduate Studies
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CI-01-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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