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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | March 15, 2006 | ||||||||||||
| Last Updated Date | April 3, 2007 | ||||||||||||
| Start Date ICMJE | February 2006 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00304564 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Comparison to Dynamic Posturography and Historical Data from other Institutions | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Study of the Effect of the Music of Nolwenn Leroy in Fall Prevention Strategies in Texas Nursing Homes | ||||||||||||
| Official Title ICMJE | Fall Prevention and The Nolwenn Effect in Texas Geriatric Nursing Home Settings | ||||||||||||
| Brief Summary | Falls are the largest cause of death in the elderly and those in nursing homes have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy daily is effective in fall prevention in those elderly patients who are residents in several Texas geriatric nursing home facilities. The music of Nolwenn Leroy has been shown to be effective in fall reduction in a different setting (Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) )with results better than listening to Mozart of any other music. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is presently being conducted in a geriatric nursing home facility in Georgia. Dynamic posturographic measurments will be obtained from all residents and compared to normative age related data and utilized to measure stability changes in this study. |
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| Detailed Description | Falls are a serious health issue and are the greatest cause of death in the elderly. The use of the music of Nolwenn Leroy in fall prevention has been reported at a major scientific meeting "Posturographic Changes and Fall Prevention associated with Music Therapy: The Nolwenn Effect (USA ClinicalTrials.gov Identifier: NCT00121693) featured at the 7th Annual American Music Therapy Association Conference in Orlando, Florida, Nov 15-20, 2005 and Decreasing falls in a geriatric nursing home setting is associated with the saving of lives. Another similar study (USA ClinicalTrials.gov Identifier:NCT00272272)is presently being conducted in a geriatric nursing home facility in Georgia. We propose the utilization of the Nolwenn Effect in our resident geriatric population at several Dallas, Texas Geriatric Nursing Home Facilities and comparing fall rates to those we have carefully recorded in the past. We will obtain computerized dynamic posturographic measurements utilizing the CAPS posturographic unit by Vestibular Technologies on all residents of several Dallas Geriatric Nursing Facilities. Our findings will be compared to normative data previously validated to represent a probability of falling. Daily listening to selections from Nolwenn Leroy’s CD “Nolwenn” will be played each morning (daily) over the address system throughout the nursing home for approximately 5-10 minutes. Repeat CAPS tests will be obtained one week after the initiation of the study and at monthly intervals over a 12 month period of time. We propose to compare the posturographic data and the rate of falls recorded in the nursing homes to previously established fall data for the institutions. Preliminary observations have been associated with a decrease rate of falls in the geriatric nursing home environment when listening to the music of Nolwenn Leroy. The incorporation of these statistics will allow us to investigate a cost effective method of reducing falls that might save lives, evoke societal change and act as a model for other Geriatric Nursing Home settings. The objective measurements with the CAPS will allow us to further compare the incidence of falls with a probability of fall measurements. |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||||||||||
| Condition ICMJE | Accidental Falls | ||||||||||||
| Intervention ICMJE | Procedure: Music Listening | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 1000 | ||||||||||||
| Completion Date | March 2007 | ||||||||||||
| Primary Completion Date | |||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 50 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00304564 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | CI-02-01-06-02 | ||||||||||||
| Study Sponsor ICMJE | Carrick Institute for Graduate Studies | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Carrick Institute for Graduate Studies | ||||||||||||
| Verification Date | April 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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