Fall PreventionEarly Phase 1NCT00368511
Fall Prevention Strategies Including Music and Posturography
A Early Phase 1 study testing Music Listening in people with Fall Prevention, run by Carrick Institute for Graduate Studies at 1 site in Netherlands.
Trial summary
We propose to obtain computerized dynamic posturography scores on patients in a (psycho)geriatric nursing home utilizing the CAPS system from Vestibular Technology. This instrument has been validated to measure human stability and is associated with a Fall Probability percentage. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention
- What is being tested?
- Music Listening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2006to Apr 2007
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a full time in patient in a geriatric hospital in Holland
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Carrick Institute for Graduate Studies-Gouda Netherlands
Gouda
About this study
Official title: The Nolwenn Effect in Geriatric Nursing Homes in the Netherlands
We propose to obtain computerized dynamic posturography scores on patients in a (psycho)geriatric nursing home utilizing the CAPS system from Vestibular Technology. This instrument has been validated to measure human stability and is associated with a Fall Probability percentage. Subjects will be asked to stand on a platform with eyes open and closed for approximately 30 seconds. The data obtained will be utilized as a base for change which can be compared to an outcome of music listening and fall prevention. Previous investigations have demonstrated a decrease in fall rates associated with music listening. We would like to measure the changes in human stability associated with a potential decrease in fall rates. We would also like to use the history of falls of the tested individuals if available. In case fall statistics are available we respectfully request access to all falls data available from the involved geriatric nursing home . The falls data will be kept confidential and only used as a control statistic in our evaluation of fall rates after implementation of our applications. The music used will include Nolwenn Leroy, Mozart and other Dutch and French Singers.
Read the detailed description
The outcome measurement will be obtained using computerized dynamic posturography, a standard diagnostic test of balance function. The subject's balance will be tested using a three-component force platform (BalanceTRAK® CAPST - Vestibular Technologies, Cheyenne WY, USA) under one sensory condition of the modified Clinical Test of Sensory Interaction on Balance (mCTSIB), the eyes closed on perturbing surface condition. This condition was chosen as studies have shown it to be the single test that best correlates with balance impairment and falls. The stability score, already used in several studies by other authors will be used as the primary outcome measure in this research. It is defined as 1 minus the ratio between the measured sway during the test (computed as the major axis of a standard 95% confidence ellipse) and the amount of sway a normal subject of the same height as the one being tested should be able to sway before falling (also known as the theoretical maximum sway or the theoretical limit of stability, calculated using a regression formula based on the subject's height developed by NASA in 1962 and commonly used in all posturographic tests). For convenience, the stability score is expressed as a percentage. Its definition makes it a convenient and easy to understand measure to use as a subject able to stand perfectly still with no sway will have a score of 100%, whereas one that sways as much as the limit of stability will have a score of 0%. During each test, the subject's sway will be determined by the force platform and its related software. The CAPST three-component force platform uses 3 load cells arranged in a triangle to measure the distribution of the vertical ground reaction force on the platform. The analog load cell signals are amplified and simultaneously sampled by the platform electronics using three synchronized individual 24bit delta-sigma analog to digital converters sampling at 312kHz and decimating the samples to a data rate of 64Hz. The use of three A/D converters insures that the signals from the 3 load cells are acquired simultaneously with no timing error. The high sampling rate with the high decimation and low data rate of the sigma-delta converters eliminates aliasing and provides a resolution of about 4 parts per million. The digital load cell data will be sent via a USB connection to the PC where software uses a calibration matrix determined by the manufacturer to compute the total vertical force and the two horizontal moments acting on the platform. From these data, the software will compute the point of application of the vertical force acting on the platform, commonly referred to as the Center of Pressure (CoP). The location of the CoP coincides in static conditions with the projection of the subject's Center of Mass (CoM) onto the platform, and its movement relates to the movements of the subject's CoM (sway). The determination of the actual sway required the determination of the instantaneous location of the CoM will require the determination of the location and inertial properties of each body segment of the specific subject being tested. The CAPST, like every other posturographic equipment, uses the movement of the CoP as an approximation of the sway. Because it is an approximation, and because for kinetic reasons the CoP moves more than the CoM, the 95% confidence interval of the CoP motion will be considered. This will allow the CAPST software to compute the ellipse that represents the location of all of the sway samples collected during the test with 95% confidence. The major axis of this ellipse represents the maximum sway of the subject in any direction during the test and it is used to compute the stability score. To assess the accuracy and resolution of the measurement chain, calibrated weights of 75kg and 100kg will be positioned in the center of the force platform (as if it were a subject) and 20s acquisitions will be performed: the accuracy of the weight will be calibrated to fall within the instrument's factory specifications (+-2N). Therefore the accuracy for the position claimed by the manufacturer of +-1mm for a weight of 75kg will be accepted as correct as determination would require specialized equipment and software available only to the manufacturer. It should be noted that the overall accuracy of the position of the CoP given by the instrument will not be relevant in this study as the sway is determined by the motion of the CoP. The sway measurement error will be estimated considering the fact that during the test at both weights the dead weight will not move, but the measurement chain will indicate a "sway" of less then 0.05mm (measurement noise), therefore the resolution of the measurement chain and the sway measurement error will be considered to be 0.05mm. To verify the repeatability of the measurement chain, the same type of tests will be repeated two times, obtaining similar results (within the specified accuracy and resolution). Given the sway measurement error, the measurement error in the stability score will be determined. From the definition of the stability score it is clear that the least the theoretical limit of stability, the more pronounced the effect of the sway measurement error is. As the theoretical limit of stability is computed by using the formula 0.55*height*2*sin(6.25°), the shorter the subject, the more the stability score is sensitive to the measurement errors. To estimate the stability score measurement error a subject's height of 1.6m will be considered. Such a subject would have a theoretical limit of stability of 191.6mm. For such a subject, a sway measurement error of 0.05mm means a stability score measurement error of 0.05/191.6 or, if the score is expressed in percentage, of 0.026%. Thus, any changes in the stability score greater than that will be as a consequence of the subject's sway and not of measurement errors. Inpatients in Dutch Geriatric Hospitals will be randomized into several groups and all will have CAPS tests obtained. The groups will be asked to listen to a music specific song each morning and CAPS tests will be obtained after the listening experiences and at one month intervals throughout the study. Fall data will be collected as well and compared to previous falls data. The changes in CAPS outcomes as a measure of brain based postural change will be compared to normative data and the types of music listened to.
- Conditions
- Fall Prevention
- Being tested
- Music Listening
- Keywords
- Fall Prevention, Dynamic Posturography, Nolwenn Effect, Music Listening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ListeningProcedure or surgery
Listen to music and posture measurements
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Listening to music and posture changes Receives: Procedure: Music Listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Historical Falls Data
Measured: Historical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Investigators
- Roland Blaauw, DC, DABCN, Study director, Carrick Institute for Graduate StudiesArjan Kuipers, DC, DABCN, Principal investigator, Carrick Institute for Graduate StudiesMarko Blanker, MD, PhD, Principal investigator, Carrick Institute for Graduate StudiesFrederick Carrick, PhD, FACCN, FICC, Study chair, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368511
- Sponsor's protocol ID
- CI-09-06-01
- Status last verified
- May 2008
- First submitted
- 23 Aug 2006
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nolwenn Effect in Geriatric Nursing Homes in the Netherlands
- ClinicalTrials.gov ID
- NCT00368511
- Acronym / sponsor ID
- CI-09-06-01
- Conditions
- Fall Prevention
- Keywords
- Fall Prevention, Dynamic Posturography, Nolwenn Effect, Music Listening
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 24 Aug 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.
We propose to obtain computerized dynamic posturography scores on patients in a (psycho)geriatric nursing home utilizing the CAPS system from Vestibular Technology. This instrument has been validated to measure human stability and is associated with a Fall Probability percentage. Subjects will be asked to stand on a platform with eyes open and closed for approximately 30 seconds. The data obtained will be utilized as a base for change which can be compared to an outcome of music listening and fall prevention. Previous investigations have demonstrated a decrease in fall rates associated with music listening. We would like to measure the changes in human stability associated with a potential decrease in fall rates. We would also like to use the history of falls of the tested individuals if available. In case fall statistics are available we respectfully request access to all falls data available from the involved geriatric nursing home . The falls data will be kept confidential and only used as a control statistic in our evaluation of fall rates after implementation of our applications. The music used will include Nolwenn Leroy, Mozart and other Dutch and French Singers.
Detailed description
The outcome measurement will be obtained using computerized dynamic posturography, a standard diagnostic test of balance function. The subject's balance will be tested using a three-component force platform (BalanceTRAK® CAPST - Vestibular Technologies, Cheyenne WY, USA) under one sensory condition of the modified Clinical Test of Sensory Interaction on Balance (mCTSIB), the eyes closed on perturbing surface condition. This condition was chosen as studies have shown it to be the single test that best correlates with balance impairment and falls. The stability score, already used in several studies by other authors will be used as the primary outcome measure in this research. It is defined as 1 minus the ratio between the measured sway during the test (computed as the major axis of a standard 95% confidence ellipse) and the amount of sway a normal subject of the same height as the one being tested should be able to sway before falling (also known as the theoretical maximum sway or the theoretical limit of stability, calculated using a regression formula based on the subject's height developed by NASA in 1962 and commonly used in all posturographic tests). For convenience, the stability score is expressed as a percentage. Its definition makes it a convenient and easy to understand measure to use as a subject able to stand perfectly still with no sway will have a score of 100%, whereas one that sways as much as the limit of stability will have a score of 0%. During each test, the subject's sway will be determined by the force platform and its related software. The CAPST three-component force platform uses 3 load cells arranged in a triangle to measure the distribution of the vertical ground reaction force on the platform. The analog load cell signals are amplified and simultaneously sampled by the platform electronics using three synchronized individual 24bit delta-sigma analog to digital converters sampling at 312kHz and decimating the samples to a data rate of 64Hz. The use of three A/D converters insures that the signals from the 3 load cells are acquired simultaneously with no timing error. The high sampling rate with the high decimation and low data rate of the sigma-delta converters eliminates aliasing and provides a resolution of about 4 parts per million. The digital load cell data will be sent via a USB connection to the PC where software uses a calibration matrix determined by the manufacturer to compute the total vertical force and the two horizontal moments acting on the platform. From these data, the software will compute the point of application of the vertical force acting on the platform, commonly referred to as the Center of Pressure (CoP). The location of the CoP coincides in static conditions with the projection of the subject's Center of Mass (CoM) onto the platform, and its movement relates to the movements of the subject's CoM (sway). The determination of the actual sway required the determination of the instantaneous location of the CoM will require the determination of the location and inertial properties of each body segment of the specific subject being tested. The CAPST, like every other posturographic equipment, uses the movement of the CoP as an approximation of the sway. Because it is an approximation, and because for kinetic reasons the CoP moves more than the CoM, the 95% confidence interval of the CoP motion will be considered. This will allow the CAPST software to compute the ellipse that represents the location of all of the sway samples collected during the test with 95% confidence. The major axis of this ellipse represents the maximum sway of the subject in any direction during the test and it is used to compute the stability score. To assess the accuracy and resolution of the measurement chain, calibrated weights of 75kg and 100kg will be positioned in the center of the force platform (as if it were a subject) and 20s acquisitions will be performed: the accuracy of the weight will be calibrated to fall within the instrument's factory specifications (+-2N). Therefore the accuracy for the position claimed by the manufacturer of +-1mm for a weight of 75kg will be accepted as correct as determination would require specialized equipment and software available only to the manufacturer. It should be noted that the overall accuracy of the position of the CoP given by the instrument will not be relevant in this study as the sway is determined by the motion of the CoP. The sway measurement error will be estimated considering the fact that during the test at both weights the dead weight will not move, but the measurement chain will indicate a "sway" of less then 0.05mm (measurement noise), therefore the resolution of the measurement chain and the sway measurement error will be considered to be 0.05mm. To verify the repeatability of the measurement chain, the same type of tests will be repeated two times, obtaining similar results (within the specified accuracy and resolution). Given the sway measurement error, the measurement error in the stability score will be determined. From the definition of the stability score it is clear that the least the theoretical limit of stability, the more pronounced the effect of the sway measurement error is. As the theoretical limit of stability is computed by using the formula 0.55*height*2*sin(6.25°), the shorter the subject, the more the stability score is sensitive to the measurement errors. To estimate the stability score measurement error a subject's height of 1.6m will be considered. Such a subject would have a theoretical limit of stability of 191.6mm. For such a subject, a sway measurement error of 0.05mm means a stability score measurement error of 0.05/191.6 or, if the score is expressed in percentage, of 0.026%. Thus, any changes in the stability score greater than that will be as a consequence of the subject's sway and not of measurement errors. Inpatients in Dutch Geriatric Hospitals will be randomized into several groups and all will have CAPS tests obtained. The groups will be asked to listen to a music specific song each morning and CAPS tests will be obtained after the listening experiences and at one month intervals throughout the study. Fall data will be collected as well and compared to previous falls data. The changes in CAPS outcomes as a measure of brain based postural change will be compared to normative data and the types of music listened to.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Procedure: Music ListeningListening to music and posture changes |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a full time in patient in a geriatric hospital in Holland
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 ListeningListen to music and posture measurements | Procedure or surgery | 1 |
Primary outcome
Historical Falls Data
Time frame: Historical
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 7 May 2008.
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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.
Roland Blaauw, DC, DABCN study director
Carrick Institute for Graduate Studies
Arjan Kuipers, DC, DABCN principal investigator
Carrick Institute for Graduate Studies
Marko Blanker, MD, 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 Listening in people with Fall Prevention, run by Carrick Institute for Graduate Studies at 1 site in Netherlands.
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 7 May 2008. 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 Netherlands. 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?
Historical Falls Data (time frame: Historical). 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 7 May 2008.