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Trial record 2 of 3 for:    nolwenn leroy

Study of the Effect of the Music of Nolwenn Leroy in Fall Prevention Strategies in Texas Nursing Homes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00304564
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies

Tracking Information
First Submitted Date  ICMJE March 15, 2006
First Posted Date  ICMJE March 20, 2006
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE February 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Dynamic Posturography [ Time Frame: immediate pre and post music listening ]
  • Historical Falls related Institutional Data [ Time Frame: From initial admissin to nursing home to present ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2006)
  • Dynamic Posturography
  • Historical Falls related Institutional Data
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2006)
Comparison to Dynamic Posturography and Historical Data from other Institutions
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Accidental Falls
Intervention  ICMJE Behavioral: Music Listening
subjects listen to music
Study Arms  ICMJE Experimental: geriatric community
Subject will stand on a computerized posturography force plate and stability scores are measured
Intervention: Behavioral: Music Listening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
100
Original Enrollment  ICMJE
 (submitted: March 16, 2006)
1000
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Geriatric Nursing Home Resident must be able to hear music

Exclusion Criteria:

  • Deafness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00304564
Other Study ID Numbers  ICMJE CI-02-01-06-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Carrick Institute for Graduate Studies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Frederick R Carrick, PhD, FACCN Carrick Institute for Graduate Studies
Principal Investigator: Natalie J Engelbart, DC, DACNB Carrick Institute for Graduate Studies
Principal Investigator: Michaele Sporaco, DC Carrick Institute for Graduate Studies
PRS Account Carrick Institute for Graduate Studies
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP