Development of an Acceleration Based Fall Risk Detector (field)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00767429
First received: October 1, 2008
Last updated: July 26, 2010
Last verified: July 2010
  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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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. 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).

  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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Rachel Senden, Drs    0433881383    rachel.senden@bw.unimaas.nl   
Fracture and osteoporose (F&O) of the policlinical MUMC Recruiting
Maastricht, Limburg, Netherlands, 6229 ER
Contact: Rachel Senden       rachel.senden@bw.unimaas.nl   
Contact: Kirsten Huntjens       K.Huntjes@AH.unimaas.nl   
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   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: kenneth Meijer, UD University Maastricht
  More Information

No publications provided

Responsible Party: Rachel Senden, Univesity Maastricht
ClinicalTrials.gov Identifier: NCT00767429     History of Changes
Other Study ID Numbers: MEC 08-3-042, ABR 22858/NL22858.068.08
Study First Received: October 1, 2008
Last Updated: July 26, 2010
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 July 31, 2014