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Balance, FallsNCT00719082

Fall Prevention:Dynamic Posturographic Measurements in the Geriatric Population

An observational study of Balance, Falls, run by Carrick Institute for Graduate Studies at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Falls are the greatest cause of accidental death in the elderly. There is no normative data on large groups of geriatric subjects specific to their stability scores obtained by computerized dynamic posturography (CDP). Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Balance, Falls
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2008to Oct 2013
Phase
Observational
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 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Volunteer subjects will be accepted from participants who are over the age of 50 years at the September, 2008 AARP convention in Washington, DC. All subjects must be able to stand with their eyes closed for 30 seconds without falling to be considered eligible for the research study.

Who may be able to join

  • All subjects must be able to stand with their eyes closed for 30 seconds without falling

Who cannot join

  • All subjects who are not able to stand with their eyes closed for 30 seconds without falling

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Walter E. Washington Convention Center

    Washington D.C., District of Columbia, 20001

Other trials in United States

About this study

Falls are the greatest cause of accidental death in the elderly. There is no normative data on large groups of geriatric subjects specific to their stability scores obtained by computerized dynamic posturography (CDP). CDP is the standard test to obtain stability scores and is utilized as the gold standard in posturographic evaluations and fall prevention

Hypotheses:

Human stability can be measured by CDP. Increased stability is associated with a lessor probability of falls. Stability decreases as age increases and a normative data collection of stability scores in the geriatric population will allow and promote clinical applications which can be utilized in fall prevention.

Read the detailed description

Computerized dynamic posturography outcomes will be obtained on geriatric subjects attending the September, 2008 AARP meeting in Washington, DC. All subjects will be volunteers. 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 (CAPS test) under one sensory condition of the modified Clinical Test of Sensory Interaction on Balance (mCTSIB), the eyes closed without perturbation. This condition is 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 will be 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 CAPS 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 24-bit delta-sigma analog to digital converters sampling at 312 kHz and decimating the samples to a data rate of 64 Hz. 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 then 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 will require the determination of the instantaneous location of the CoM via the location and inertial properties of each body segment of the specific subject being tested. The CAPS test, like all 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 CAPS 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 will represent the maximum sway of the subject in any direction during the test and it will be used to compute the stability score. To assess the accuracy and resolution of the measurement chain, calibrated weights of 75 kg and 100 kg will be positioned in the center of the force platform (as if it were a subject) and 20 sec acquisitions will be performed: The accuracy of the weight must fall within the instrument's factory specifications (+2N). Therefore the accuracy for the position claimed by the manufacturer of +1 mm for a weight of 75 kg will be accepted as correct as it determination would have required 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 motion of the CoP will determine the sway. 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 0.05 mm (measurement noise), therefore the resolution of the measurement chain and the sway measurement error will be considered to be 0.05 mm. To verify the repeatability of the measurement chain, the same type of tests will be repeated two times. The authors have obtained similar results (within the specified accuracy and resolution) in another study. 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 will be. As the theoretical limit of stability is computed by using the formula 0.556height626sin(6.258), 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 1.6 m will be considered. Such a subject would have a theoretical limit of stability of 191.6 mm. For such a subject, a sway measurement error of 0.05 mm 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 are a consequence of the subject's sway and not of measurement errors. A CAPS sit to stand test in which the subject will be asked to stand on the force platform from a sitting position followed by a posturography test in the eyes closed stance will be obtained on all subjects. Subjects will be instructed that they will sit on a chair and then stand up without using their hands or a structure for support. They then wil be instructed to stand on a computerized force plate platform without pertubation and close their eyes while data is obtained from the computerized force plate. The subjects will be given practice sessions so that they will be familiar with the test prior to the collection of data. The CAPS testing, including the sit to stand and the eyes closed standing test occurs over 90 sec. We will divide the degree of sway observed during the first half of the eyes closed standing test (10 seconds) and the second half of the eyes closed standing test (10 seconds)and obtain ratios. If a subjects sway increases in the second half of the test in reference to the first half we will call this a fatigability ratio. When individuals demonstrate less sway in the second half of the test we will call this an adaptability ratio that we consider might be related to some type of motor learning.

Conditions
Balance, Falls
Keywords
Human Stability, Geriatric, Posturography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00719082
Study groupRoleWhat they receive
AARP CommunityMembers of AARP Geriatric Community

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forceplate dynamic posturography test

    Measured: Immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionOct 2013 (estimated)
  4. Study completionOct 2013 (estimated)

Why it stopped: Lack of Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719082
Sponsor's protocol ID
CI-IRB-01-7-7-08
Status last verified
Jan 2016
First submitted
17 Jul 2008
Last updated
27 Jan 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Balance, 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.

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?

Forceplate dynamic posturography test (time frame: Immediate). 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.

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