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

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:
NCT00765297
First received: September 30, 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 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 Intervention Phase
Fall Risk
Device: fall related movement (stumble) detector
Device: fall related movement characteristic (stumble) detector
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Identify Subjects at Risk for Falling Using Acceleration Based Gait Analysis System

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • accelerations and acceleration based movement parameters [ Time Frame: 1 time (1,5 -2 hours) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2007
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
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Rachel Senden, University Maastricht
ClinicalTrials.gov Identifier: NCT00765297     History of Changes
Other Study ID Numbers: MEC 07-3-045, NL17267.068.07
Study First Received: September 30, 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:
fall risk
movement characteristics
stumble detection
accelerometry

ClinicalTrials.gov processed this record on October 01, 2014