Fall RiskfieldNCT00767429
Development of an Acceleration Based Fall Risk Detector
A study testing fall risk detector in people with Fall Risk, run by Maastricht University Medical Center at 4 sites in Netherlands.
Trial summary
Because the increasing fall problem, mainly due to an impaired gait and balance ability, this study will investigate fall risk by detecting fall related movement characteristics. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Risk
- What is being tested?
- fall risk detector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesNetherlands
- Study dates
- Aug 2008to Oct 2010
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Having a fall risk (Tinetti score between 19-24)
- Men and women older than 65 years at risk for falling - able to walk without walking aids - voluntary and willing to participate
- Fully competent
Who cannot join
- Unable to walk
- Denying
- Very high fall risk (Tinetti score < 19)
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites, 4 recruiting
- Recruiting
Zorgboog
Bakel, Bakel, 5760 AA
Marieke Lucassen, marieke.lucassen@student.unimaas.nl
Marieke Lucassen
- Recruiting
University Maastricht
Maastricht, Limburg, 6200 MD
Rachel Senden, Drs, 0433881383, rachel.senden@bw.unimaas.nl
- Recruiting
Fracture and osteoporose (F&O) of the policlinical MUMC
Maastricht, Limburg, 6229 ER
Rachel Senden, rachel.senden@bw.unimaas.nl
Kirsten Huntjens, K.Huntjes@AH.unimaas.nl
- Recruiting
Stichting Modae ZOrggrope locatie Scharwyerveld
Maastricht, Maastricht, 6201 CA
Lieve Van Russelt, Lieve.Vanrusselt@mosaezorggroep.nl
About this study
Because the increasing fall problem, mainly due to an impaired gait and balance ability, this study will investigate fall risk by detecting fall related movement characteristics. Based on the promising results using accelerometry for accurate and objective gait analysis, fall risk will be measured using a triaxial accelerometer.
At the moment our group is performing a study titled 'identify subjects at risk for falling using accelerometry'. In this study, fall related movement characteristics (gait, balance, stumble reaction) are identified in healthy younger and older subjects under standardised laboratory circumstances. In this way, specific characteristics can be selected which are responsible for fall risk.
The aim of this study is investigating if the acceleration based fall risk detector can be applied in daily life with target groups.
Read the detailed description
A first step to field measurement with target group is the measurement of elderly with a certain fall risk in a simple field condition like a nursing home.
First fall risk is assessed in elderly using the Tinetti scale (score between 19-24) which is the gold standard for fall risk assessment . This scale consist of a gait and balance score. Only subjects who have a fall risk are included for further measurements.
- 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 (antero-posterior, media-lateral and cranial-caudal) with a sample frequency of 100Hz.
- 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.
- The Get Up and Go test is performed: subjects start in sitting position, have to rise, walk 3m, turn around, walk back and sit again. The time needed to perform this test is measured.
- 20 subjects (remaining in Scharweyerveld and Zorgboog) are monitored for one day and 20 elderly women (>70y) (recruited at the F\&O policlinic MUMC)are measured for 5 successive days, to investigate the mobility and more fall related movement parameters. The accelerometer is attached to the sacrum in the morning. First the other 2 measurements are performed, and then subjects wear the device during the whole day. The accelerometer is small, light and ambulant which is not interfering with daily activities. Subjects have to keep a diary to note all activities performed during that day. THis will be used to explain the acceleration signal.
For the subject recruited from the F\&O poli, a fall diary is kept for one year were subjects have to note when a fall has happened. In addition muscle strength in measured in this population and a questionnaire concerning quality of life (Euroqol) is completed in this group.
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 perform the Get Up and Go test. Pearson correlation will also be used to validate the objective gait and balance test with the Tinetti scale. Differences in function tests between elderly at risk (measured in this study) and healthy subjects (measured in a previous study under lab conditions) will be investigated using ANOVA (p< 0.005).
- Conditions
- Fall Risk
- Being tested
- fall risk detector
- Keywords
- accelerometer, fall risk, target group, field measurements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall risk detectorDevice
fall risk detector: stumbles, specific fall related movements, falls
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | subjects with fall risk Receives: Device: fall risk detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceleration based movement characteristics
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall RiskStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- kenneth Meijer, UD, Study chair, University Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767429
- Sponsor's protocol ID
- MEC 08-3-042
- Other IDs
- ABR 22858/NL22858.068.08
- Acronym
- field
- Status last verified
- Jul 2010
- First submitted
- 1 Oct 2008
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Acceleration Based Fall Risk Detector
- ClinicalTrials.gov ID
- NCT00767429
- Acronym / sponsor ID
- field / MEC 08-3-042
- Conditions
- Fall Risk
- Keywords
- accelerometer, fall risk, target group, field measurements
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 7 Oct 2008 (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.
Because the increasing fall problem, mainly due to an impaired gait and balance ability, this study will investigate fall risk by detecting fall related movement characteristics. Based on the promising results using accelerometry for accurate and objective gait analysis, fall risk will be measured using a triaxial accelerometer.
At the moment our group is performing a study titled 'identify subjects at risk for falling using accelerometry'. In this study, fall related movement characteristics (gait, balance, stumble reaction) are identified in healthy younger and older subjects under standardised laboratory circumstances. In this way, specific characteristics can be selected which are responsible for fall risk.
The aim of this study is investigating if the acceleration based fall risk detector can be applied in daily life with target groups.
Detailed description
A first step to field measurement with target group is the measurement of elderly with a certain fall risk in a simple field condition like a nursing home.
First fall risk is assessed in elderly using the Tinetti scale (score between 19-24) which is the gold standard for fall risk assessment . This scale consist of a gait and balance score. Only subjects who have a fall risk are included for further measurements.
- 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 (antero-posterior, media-lateral and cranial-caudal) with a sample frequency of 100Hz.
- 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.
- The Get Up and Go test is performed: subjects start in sitting position, have to rise, walk 3m, turn around, walk back and sit again. The time needed to perform this test is measured.
- 20 subjects (remaining in Scharweyerveld and Zorgboog) are monitored for one day and 20 elderly women (>70y) (recruited at the F\&O policlinic MUMC)are measured for 5 successive days, to investigate the mobility and more fall related movement parameters. The accelerometer is attached to the sacrum in the morning. First the other 2 measurements are performed, and then subjects wear the device during the whole day. The accelerometer is small, light and ambulant which is not interfering with daily activities. Subjects have to keep a diary to note all activities performed during that day. THis will be used to explain the acceleration signal.
For the subject recruited from the F\&O poli, a fall diary is kept for one year were subjects have to note when a fall has happened. In addition muscle strength in measured in this population and a questionnaire concerning quality of life (Euroqol) is completed in this group.
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 perform the Get Up and Go test. Pearson correlation will also be used to validate the objective gait and balance test with the Tinetti scale. Differences in function tests between elderly at risk (measured in this study) and healthy subjects (measured in a previous study under lab conditions) will be investigated using ANOVA (p< 0.005).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: fall risk detectorsubjects with fall risk |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Having a fall risk (Tinetti score between 19-24)
- Men and women older than 65 years at risk for falling - able to walk without walking aids - voluntary and willing to participate
- Fully competent
Key exclusion criteria (3 listed)
- Unable to walk
- Denying
- Very high fall risk (Tinetti score < 19)
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 |
|---|---|---|
| fall risk detectorfall risk detector: stumbles, specific fall related movements, falls | Device | 1 |
Primary outcome
Acceleration based movement characteristics
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
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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.
kenneth Meijer, UD study chair
University Maastricht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fall risk detector in people with Fall Risk, run by Maastricht University Medical Center at 4 sites 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 3 inclusion and 3 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 4 sites 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.
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, drs (043 3881383, 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?
Acceleration based movement characteristics (time frame: 1 day). 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.