Accidental FallsEarly Phase 1NCT00121693
The Use of Music Therapy in the Prevention of Falls
A Early Phase 1 study testing Music therapy (listening to specific music) in people with Accidental Falls and Healthy, run by Carrick Institute for Graduate Studies at 1 site in United States.
Trial summary
The purpose of this study is to determine whether listening to music will demonstrate changes in human postural stability and whether those changes might be useful in fall prevention strategies. Read more about this study
- Who is it for?
- Ages 17 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Healthy
- What is being tested?
- Music therapy (listening to specific music)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Oct 2006
- Phase
- Early Phase 1
- 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 17 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- No history of previous fall(s) or dizziness
Who cannot join
- History of previous fall(s) or dizziness
Trial locations and contacts
1 site in 1 country.
United States1 site
Carrick Institute for Graduate Studies
Cape Canaveral, Florida, 32920
About this study
Official title: Posturographic Changes Associated With Music Therapy and Fall Prevention
The purpose of this study is to determine whether listening to music will demonstrate changes in human postural stability and whether those changes might be useful in fall prevention strategies.
Read the detailed description
Falls are a serious health issue and are the greatest cause of death in the elderly. The use of music therapy in fall prevention has not been reported in the literature. This investigation will provide experimental support to the assumption that music therapy may prevent falls and that certain music can affect increases in postural stability using randomly selected subjects, validated posturography and a full experimental design.
Computer dynamic posturography (CDP) tests will provide stability scores in volunteer subjects who have had no previous history of falls or vertigo. Subjects will be randomized into several different music listening groups and one control group. Examiners will be blinded as to the music listened to and the outcome measurements. Subjects will be blinded as to their posturographic measurements. The music listening groups will be given a daily specific music listening task. CDP tests will be obtained 10 minutes, 1 week and 1 month after subject's treatment. Music selection will include Mozart, Nolwenn Leroy and others suggested to change human stability.
- Conditions
- Accidental Falls, Healthy
- Being tested
- Music therapy (listening to specific music)
- Keywords
- Fall prevention, posturography, music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy (listening to specific music)Behavioural
Listening to Music
| Study group | Role | What they receive |
|---|---|---|
| Music Listening 1 | Experimental | Intervention: Listen to Music type 1 Receives: Behavioral: Music therapy (listening to specific music) |
| Music Listening 2 | Experimental | Intervention: Listen to Music type 2 Receives: Behavioral: Music therapy (listening to specific music) |
| Music LIstening 3 | Experimental | Intervention: Listen to Music type 3 Receives: Behavioral: Music therapy (listening to specific music) |
| Control | No intervention | Intervention: Listen to White noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pretest and posttest scores will be collected for ten treatment conditions at three post-treatment times (10 minutes, 1 week, and 1 month)
balance testing before and after listening to music
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 posted21 Jul 2005 (estimated)
- Study startDec 2003
- Primary completionSep 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 266 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 StudiesElena Ogerro, PhD, Principal investigator, Carrick Institute for Graduate StudiesGuido Pagnacco, PhD, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121693
- Sponsor's protocol ID
- CI-01-03
- Status last verified
- Jan 2016
- First submitted
- 15 Jul 2005
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Carrick FR, Oggero E, Pagnacco G. Posturographic changes associated with music listening. J Altern Complement Med. 2007 Jun;13(5):519-26. doi: 10.1089/acm.2007.7020.
PubMed 17604555
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
- Posturographic Changes Associated With Music Therapy and Fall Prevention
- ClinicalTrials.gov ID
- NCT00121693
- Acronym / sponsor ID
- CI-01-03
- Conditions
- Accidental Falls, Healthy
- Keywords
- Fall prevention, posturography, music therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 21 Jul 2005 (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.
The purpose of this study is to determine whether listening to music will demonstrate changes in human postural stability and whether those changes might be useful in fall prevention strategies.
Detailed description
Falls are a serious health issue and are the greatest cause of death in the elderly. The use of music therapy in fall prevention has not been reported in the literature. This investigation will provide experimental support to the assumption that music therapy may prevent falls and that certain music can affect increases in postural stability using randomly selected subjects, validated posturography and a full experimental design.
Computer dynamic posturography (CDP) tests will provide stability scores in volunteer subjects who have had no previous history of falls or vertigo. Subjects will be randomized into several different music listening groups and one control group. Examiners will be blinded as to the music listened to and the outcome measurements. Subjects will be blinded as to their posturographic measurements. The music listening groups will be given a daily specific music listening task. CDP tests will be obtained 10 minutes, 1 week and 1 month after subject's treatment. Music selection will include Mozart, Nolwenn Leroy and others suggested to change human stability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Music Listening 1 | Experimental | Behavioral: Music therapy (listening to specific music)Intervention: Listen to Music type 1 |
| Music Listening 2 | Experimental | Behavioral: Music therapy (listening to specific music)Intervention: Listen to Music type 2 |
| Music LIstening 3 | Experimental | Behavioral: Music therapy (listening to specific music)Intervention: Listen to Music type 3 |
| Control | No intervention | –Intervention: Listen to White noise |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- No history of previous fall(s) or dizziness
Key exclusion criteria (1 listed)
- History of previous fall(s) or dizziness
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 therapy (listening to specific music)Listening to Music | Behavioural | Music LIstening 3, Music Listening 1, Music Listening 2 |
Primary outcome
Pretest and posttest scores will be collected for ten treatment conditions at three post-treatment times (10 minutes, 1 week, and 1 month)
Time frame: Immediate pre and post balance testing
balance testing before and after listening to music
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.
- Background: PubMed 17604555Carrick FR, Oggero E, Pagnacco G. Posturographic changes associated with music listening. J Altern Complement Med. 2007 Jun;13(5):519-26. doi: 10.1089/acm.2007.7020.
- 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
Elena Ogerro, PhD principal investigator
Carrick Institute for Graduate Studies
Guido Pagnacco, PhD 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 Early Phase 1 study testing Music therapy (listening to specific music) in people with Accidental Falls and Healthy, 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pretest and posttest scores will be collected for ten treatment conditions at three post-treatment times (10 minutes, 1 week, and 1 month) (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?
On the ClinicalTrials.gov record for NCT00121693, which also lists 1 linked publication.
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.