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Fall RiskEarly Phase 1stumbleNCT00765297

Identify Subjects at Risk for Falling Using Acceleration Based Gait Analysis System

A Early Phase 1 study testing fall related movement (stumble) detector and fall related movement characteristic (stumble) detector in people with Fall Risk, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Because the increasing fall problem, mainly due to an impaired gait and balance ability and partly caused by trips, this study will investigate fall risk by detecting fall related movement characteristics and by detecting stumbles inclusive the compensation mechanism to recover from the trip. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Fall Risk
What is being tested?
fall related movement (stumble) detector and fall related movement characteristic (stumble) detector
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteNetherlands
Study dates
Sep 2007to Oct 2010
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 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • able to walk without walking aids
  • signed informed consent
  • willing to participate
  • healthy volunteers = no musculo skeletal or neurological disease
  • the younger volunteers are aged between 18 and 40 years, while the elderly are 60 years or older

Who cannot join

  • history of dizziness
  • vestibular dysfunction
  • neurological disorders
  • low-back pain
  • lower extremity infirmity/pathology
  • suffering from any osteoarthritic or musculo skeletal disease at the time of testing
  • unable to walk

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • University Maastricht

    Maastricht, Limburg, 6200 MD

    Kenneth Meijer, UD, 0433881384, kenneth.meijer@bw.unimaas.nl

    Rachel Senden, Drs

    Recruiting

Other trials in Netherlands

About this study

Because the increasing fall problem, mainly due to an impaired gait and balance ability and partly caused by trips, this study will investigate fall risk by detecting fall related movement characteristics and by detecting stumbles inclusive the compensation mechanism to recover from the trip. Based on the promising results using accelerometry for accurate and objective gait analysis, fall risk will be measured in younger and older (>60y) subjects using a triaxial accelerometer.

Read the detailed description

To investigate fall risk objectively, fall related movement characteristics (based on gait and balance) and the ability to compensate for near falls are analyzed in younger and older (>60y) subjects under standardized laboratory conditions.

Four tests will be performed to link specific movement parameters, balance performance and the ability to recover from a trip with fall risk:

  1. Fall risk will be assessed using the Tinetti Scale, the gold standard for fall risk assessment . This scale consist of a gait and balance score. Based on this scale, subjects are classified as being at risk/ not at risk for falling.
  2. A gait test will be performed to analyze movement parameters. Subjects have to walk 6 times a 20 meter distance at preferred speed while a small (56mmx61mmx15mm), light weight (5g) and ambulant accelerometer is attached on the sacrum with an elastic belt. The accelerometer measures accelerations of the body in three directions (anterior-posterior, media-lateral and cranial-caudal) with a sample frequency of 100Hz.
  3. The balance ability will be tested by performing 4 balance tasks while the same accelerometer measures the movements of the body. Subjects have to stand with feet closed on a normal or foam surface while having the eyes open and closed.
  4. Finally a stumble experiment is done to assess the ability to compensate for a trip. Subjects are asked to walk at their preferred speed on a treadmill, while wearing the accelerometer attached at the sacrum. After 2 minutes of normal walking, stumbles are simulated unexpectedly using an extending tripping leash attached to both legs. The subjects are able to move freely due to unwinding and winding of the cord on a spill on a fixed frame behind the treadmill. This spill has a blocking device capable of blocking the leash very shortly. During the mid or initial swing of one of the legs, the examiner blocks the leash causing the subject to trip. Falling, however, is not possible due to a safety harness attached to the ceiling. When this harness starts bearing weight an emergency switch is engaged stopping the treadmill immediately. After a perturbation, subjects get several seconds to recover until a new perturbation is applied. This measurement is repeated while walking at a slow (40% Fr preferred speed) and fast (20% Fr preferred speed) speed. The whole experiment will be recorded on video to validate the acceleration based stumble detection.

To investigate the underlying mechanism of age related mobility changes, two other tests are incorporated:

  • The cognition of the subjects will be tested using a reaction time test. Subjects sit behind the computer with their middle and forefinger on two keys of the typewriter. Four squares will appear at the computer screen. Or all squares are red and one of them will change in green (=uncued condition) or two red squares appear at the left (right) side while one square at the right (left) side will turn green. Subjects have to push the corresponding key on the typewriter as fast but also as accurate as possible. With this test the ability to change an automatic response (in stead of responding left when stimulus appears left) can be investigated using reaction times. First the subjects get an instruction, than they get the possibility to try and exercise 10 times, while afterwards the real test will start. 120 attempts are performed in which the cued and uncued stimuli appear with different time intervals (100ms, 250ms, 500ms, 750ms and 12000 ms).
  • Muscle strength of the right lower leg is tested using the Cybex. Subjects have to produce maximal force during an extension and flexion test.

All acceleration data will be analyzed using specific algorithms programmed in Matlab(c). Statistical analysis will be performed in SPSS using pearson correlation to investigate correlations between gait parameters, balance characteristics and the ability to recover from a trip. Moreover Pearson correlations and regression analysis will be done to investigate the relation of cognition and muscle strength with fall risk (gait, stumble recovery and balance). Pearson correlation will also be used to validate the objective gait and balance test with the Berg Balance Scale. Differences in muscle strength, cognition gait, balance and compensation ability between younger and older subjects will be investigated using ANOVA (p< 0.005).

Conditions
Fall Risk
Being tested
fall related movement (stumble) detector, fall related movement characteristic (stumble) detector
Keywords
fall risk, movement characteristics, stumble detection, accelerometry

What participants receive

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

  • fall related movement (stumble) detectorDevice

    movement pattern (gait,balance) of young subjects recovery of a stumble in young subjects

  • fall related movement characteristic (stumble) detectorDevice

    age related gait changes influencing movement pattern different pattern to recover from a trip

Study groups in NCT00765297
Study groupRoleWhat they receive
1ExperimentalHealthy young 18-40years
Receives: Device: fall related movement (stumble) detector
2ExperimentalHealthy elderly
Receives: Device: fall related movement characteristic (stumble) detector

What is being measured

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

  1. accelerations and acceleration based movement parameters

    Measured: 1 time (1,5 -2 hours)

Timeline

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

  1. First posted2 Oct 2008 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2010 (estimated)
  4. Study completionOct 2010 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00765297
Sponsor's protocol ID
MEC 07-3-045
Other IDs
NL17267.068.07
Acronym
stumble
Status last verified
Jul 2010
First submitted
30 Sep 2008
Last updated
27 Jul 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing fall related movement (stumble) detector and fall related movement characteristic (stumble) detector in people with Fall Risk, run by Maastricht University Medical Center 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jul 2010. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rachel Senden, dr (06 34023131, rachel.senden@bw.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accelerations and acceleration based movement parameters (time frame: 1 time (1,5 -2 hours)). 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 Jul 2010; AzTrials last refreshed its copy on 28 Oct 2026.

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