- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00304564
Study of the Effect of the Music of Nolwenn Leroy in Fall Prevention Strategies in Texas Nursing Homes
January 26, 2016 updated by: Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
Fall Prevention and The Nolwenn Effect in Texas Geriatric Nursing Home Settings
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Flower Mound, Texas, United States, 75028-7596
- Carrick Institute for Graduate Studies
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Geriatric Nursing Home Resident must be able to hear music
Exclusion Criteria:
- Deafness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: geriatric community
Subject will stand on a computerized posturography force plate and stability scores are measured
|
subjects listen to music
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dynamic Posturography
Time Frame: immediate pre and post music listening
|
immediate pre and post music listening
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Historical Falls related Institutional Data
Time Frame: From initial admissin to nursing home to present
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From initial admissin to nursing home to present
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Natalie J Engelbart, DC, DACNB, Carrick Institute for Graduate Studies
- Principal Investigator: Michaele Sporaco, DC, Carrick Institute for Graduate Studies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (ACTUAL)
April 1, 2006
Study Completion (ACTUAL)
March 1, 2007
Study Registration Dates
First Submitted
March 15, 2006
First Submitted That Met QC Criteria
March 16, 2006
First Posted (ESTIMATE)
March 20, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
January 27, 2016
Last Update Submitted That Met QC Criteria
January 26, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CI-02-01-06-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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