Accidental FallsNCT00304564
Study of the Effect of the Music of Nolwenn Leroy in Fall Prevention Strategies in Texas Nursing Homes
A study testing Music Listening in people with Accidental Falls, run by Carrick Institute for Graduate Studies at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Geriatric Nursing Home Resident must be able to hear music
Who cannot join
- Deafness
Trial locations and contacts
1 site in 1 country.
United States1 site
Carrick Institute for Graduate Studies
Flower Mound, Texas, 75028-7596
About this study
Official title: 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.
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- Music Listening
- Keywords
- Posturography, Fall Prevention, Geriatrics, Nolwenn Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningBehavioural
subjects listen to music
| Study group | Role | What they receive |
|---|---|---|
| geriatric community | Experimental | Subject will stand on a computerized posturography force plate and stability scores are measured Receives: Behavioral: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Posturography
Measured: immediate pre and post music listening
Historical Falls related Institutional Data
Measured: From initial admissin to nursing home to present
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
- Investigators
- Frederick R Carrick, PhD, FACCN, Study director, Carrick Institute for Graduate StudiesNatalie J Engelbart, DC, DACNB, Principal investigator, Carrick Institute for Graduate StudiesMichaele Sporaco, DC, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304564
- Sponsor's protocol ID
- CI-02-01-06-02
- Status last verified
- Jan 2016
- First submitted
- 15 Mar 2006
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Prevention and The Nolwenn Effect in Texas Geriatric Nursing Home Settings
- ClinicalTrials.gov ID
- NCT00304564
- Acronym / sponsor ID
- CI-02-01-06-02
- Conditions
- Accidental Falls
- Keywords
- Posturography, Fall Prevention, Geriatrics, Nolwenn Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| geriatric community | Experimental | Behavioral: Music ListeningSubject will stand on a computerized posturography force plate and stability scores are measured |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Geriatric Nursing Home Resident must be able to hear music
Key exclusion criteria (1 listed)
- Deafness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Listeningsubjects listen to music | Behavioural | geriatric community |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick R Carrick, PhD, FACCN study director
Carrick Institute for Graduate Studies
Natalie J Engelbart, DC, DACNB principal investigator
Carrick Institute for Graduate Studies
Michaele Sporaco, DC principal investigator
Carrick Institute for Graduate Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening in people with Accidental Falls, run by Carrick Institute for Graduate Studies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Posturography (time frame: immediate pre and post music listening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.