AtaxiaNCT00272272
Fall Prevention in a Geriatric Nursing Home Setting Using the Music of Nolwenn Leroy
A study testing Music Therapy in people with Ataxia, 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 with dementia have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy is effective in fall prevention in those elderly patients who are residents in a Geriatric Nursing Home… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ataxia
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Full time resident in Geriatric Facility
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
United States1 site
Budd Terrace Geriatric Nursing Home
Atlanta, Georgia, 30329
About this study
Official title: The Nolwenn Effect in a Geriatric Nursing Home Setting
Falls are the largest cause of death in the elderly and those with dementia have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy is effective in fall prevention in those elderly patients who are residents in a Geriatric Nursing Home Facility. 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.
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 is in publication in the indexed literature. Decreasing falls in a geriatric nursing home setting is associated with the saving of lives. We propose the utilization of the Nolwenn Effect in our resident geriatric population and comparing fall rates to those we have carefully recorded in the past.
Daily listening to selections from Nolwenn Leroy's CD "Nolwenn" have been played for one month in the community gathering areas of our fourth floor dementia unit in the morning for approximately 5-10 minutes. This unit has an increased rate of falls due to the characteristics of its residents and our one month retrospective study has demonstrated a statistical reduction in the rate of falls subsequent to the daily listening of Nolwenn Leroy music. We propose to expand the listening of music to the entire building and study the Nolwenn Effect on the fall rate of all residents over the calendar year 2006.
Preliminary observations have been associated with a decrease rate of falls on our dementia floor when compared to our previous fall rates. Our nursing staff is well trained in fall reporting and will continue to do so in the manner previously established before implementation of this study. This study is dependant upon the utilization of fall statistics previously established at our institution. The incorporation of these statistics will allow us to demonstrate 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.
- Conditions
- Ataxia
- Being tested
- Music Therapy
- Keywords
- Fall Prevention, Music Therapy, Geriatric, Nursing Home
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Listening to Music while standing
| Study group | Role | What they receive |
|---|---|---|
| Balance and Music Listening | Experimental | Music therapy Receives: Behavioral: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fall rate
Measured: immediate pre and post balance testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionOct 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 AtaxiaStudies 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
- 200 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, Principal investigator, Carrick Institute for Graduate StudiesJulie Kinney, MT-BC, Study director, Carrick Institute for Graduate StudiesElizabeth Eakes, MT-BC, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272272
- Sponsor's protocol ID
- CI-01-01-06-01
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 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
- The Nolwenn Effect in a Geriatric Nursing Home Setting
- ClinicalTrials.gov ID
- NCT00272272
- Acronym / sponsor ID
- CI-01-01-06-01
- Conditions
- Ataxia
- Keywords
- Fall Prevention, Music Therapy, Geriatric, Nursing Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 5 Jan 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 with dementia have even a higher incidence of falling. The purpose of this study is to determine whether listening to the Music of Nolwenn Leroy is effective in fall prevention in those elderly patients who are residents in a Geriatric Nursing Home Facility. 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.
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 is in publication in the indexed literature. Decreasing falls in a geriatric nursing home setting is associated with the saving of lives. We propose the utilization of the Nolwenn Effect in our resident geriatric population and comparing fall rates to those we have carefully recorded in the past.
Daily listening to selections from Nolwenn Leroy's CD "Nolwenn" have been played for one month in the community gathering areas of our fourth floor dementia unit in the morning for approximately 5-10 minutes. This unit has an increased rate of falls due to the characteristics of its residents and our one month retrospective study has demonstrated a statistical reduction in the rate of falls subsequent to the daily listening of Nolwenn Leroy music. We propose to expand the listening of music to the entire building and study the Nolwenn Effect on the fall rate of all residents over the calendar year 2006.
Preliminary observations have been associated with a decrease rate of falls on our dementia floor when compared to our previous fall rates. Our nursing staff is well trained in fall reporting and will continue to do so in the manner previously established before implementation of this study. This study is dependant upon the utilization of fall statistics previously established at our institution. The incorporation of these statistics will allow us to demonstrate 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance and Music Listening | Experimental | Behavioral: Music TherapyMusic therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Full time resident in Geriatric Facility
Key exclusion criteria (1 listed)
- All others
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 TherapyListening to Music while standing | Behavioural | Balance and Music Listening |
Primary outcome
Changes in Fall rate
Time frame: immediate pre and post balance testing
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 principal investigator
Carrick Institute for Graduate Studies
Julie Kinney, MT-BC study director
Carrick Institute for Graduate Studies
Elizabeth Eakes, MT-BC 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 Therapy in people with Ataxia, 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?
Changes in Fall rate (time frame: immediate pre and post balance testing). 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.