Development of an Acceleration Based Fall Risk Detector (field)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00767429
Recruitment Status : Unknown
Verified July 2010 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 7, 2008
Last Update Posted : July 27, 2010
Information provided by:
Maastricht University Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Fall Risk Device: fall risk detector Not Applicable

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.

  1. 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.
  2. 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.
  3. 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.
  4. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of an Acceleration Based Fall Risk Detector
Study Start Date : August 2008
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
subjects with fall risk
Device: fall risk detector
fall risk detector: stumbles, specific fall related movements, falls

Primary Outcome Measures :
  1. Acceleration based movement characteristics [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unable to walk
  • Denying
  • Very high fall risk (Tinetti score < 19)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00767429

Contact: Rachel Senden, drs 043 3881383

University Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Rachel Senden, Drs    0433881383   
Fracture and osteoporose (F&O) of the policlinical MUMC Recruiting
Maastricht, Limburg, Netherlands, 6229 ER
Contact: Rachel Senden   
Contact: Kirsten Huntjens   
Zorgboog Recruiting
Bakel, Netherlands, 5760 AA
Contact: Marieke Lucassen   
Sub-Investigator: Marieke Lucassen         
Stichting Modae ZOrggrope locatie Scharwyerveld Recruiting
Maastricht, Netherlands, 6201 CA
Contact: Lieve Van Russelt   
Sponsors and Collaborators
Maastricht University Medical Center
Study Chair: kenneth Meijer, UD University Maastricht

Responsible Party: Rachel Senden, Univesity Maastricht Identifier: NCT00767429     History of Changes
Other Study ID Numbers: MEC 08-3-042
ABR 22858/NL22858.068.08
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

Keywords provided by Maastricht University Medical Center:
fall risk
target group
field measurements