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Development of an Acceleration Based Fall Risk Detector (field)
This study is currently recruiting participants.
Verified by Maastricht University Medical Center, October 2008
Sponsored by: Maastricht University Medical Center
Information provided by: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00767429
  Purpose

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 Intervention
Fall Risk
Device: fall risk detector

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Open Label, Single Group Assignment
Official Title: Development of an Acceleration Based Fall Risk Detector

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Acceleration based movement characteristics [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
subjects with fall risk
Device: fall risk detector
fall risk detector: stumbles, specific fall related movements, falls

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. 40 subjects (remaining in Scharweyerveld and Zorgboog) are monitored for one day 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.

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).

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Having a fall risk (Tinetti score between 19-24 )
  • Men and women ≥ 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767429

Contacts
Contact: Rachel Senden, drs 043 3881383 rachel.senden@bw.unimaas.nl

Locations
Netherlands
Zorgboog Recruiting
Bakel, Netherlands, 5760 AA
Contact: Marieke Lucassen         marieke.lucassen@student.unimaas.nl    
Sub-Investigator: Marieke Lucassen            
Stichting Modae ZOrggrope locatie Scharwyerveld Recruiting
Maastricht, Netherlands, 6201 CA
Contact: Lieve Van Russelt         Lieve.Vanrusselt@mosaezorggroep.nl    
Netherlands, Limburg
University Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Rachel Senden, Drs     0433881383     rachel.senden@bw.unimaas.nl    
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: kenneth Meijer, UD University Maastricht
  More Information

Responsible Party: Univesity Maastrict ( Rachel Senden )
Study ID Numbers: MEC 08-3-042, ABR 22858/NL22858.068.08
Study First Received: October 1, 2008
Last Updated: October 6, 2008
ClinicalTrials.gov Identifier: NCT00767429  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on January 16, 2009