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

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ClinicalTrials.gov Identifier: NCT00765297
Recruitment Status : Unknown
Verified July 2010 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 2, 2008
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Maastricht University Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Fall Risk Device: fall related movement (stumble) detector Device: fall related movement characteristic (stumble) detector Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Identify Subjects at Risk for Falling Using Acceleration Based Gait Analysis System
Study Start Date : September 2007
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
Healthy young 18-40years
Device: fall related movement (stumble) detector
movement pattern (gait,balance) of young subjects recovery of a stumble in young subjects
Experimental: 2
Healthy elderly
Device: fall related movement characteristic (stumble) detector
age related gait changes influencing movement pattern different pattern to recover from a trip



Primary Outcome Measures :
  1. accelerations and acceleration based movement parameters [ Time Frame: 1 time (1,5 -2 hours) ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT00765297


Contacts
Contact: Rachel Senden, dr 06 34023131 rachel.senden@bw.unimaas.nl

Locations
Netherlands
University Maastricht Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Kenneth Meijer, UD    0433881384    kenneth.meijer@bw.unimaas.nl   
Principal Investigator: Rachel Senden, Drs         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Study Chair: kenneth Meijer, UD University Maastricht

Responsible Party: Rachel Senden, University Maastricht
ClinicalTrials.gov Identifier: NCT00765297     History of Changes
Other Study ID Numbers: MEC 07-3-045
NL17267.068.07
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010

Keywords provided by Maastricht University Medical Center:
fall risk
movement characteristics
stumble detection
accelerometry