NCT00765297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2007

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

July 27, 2010

Status Verified

July 1, 2010

Enrollment Period

3.1 years

First QC Date

September 30, 2008

Last Update Submit

July 26, 2010

Conditions

Fall Risk

Keywords

fall riskmovement characteristicsstumble detectionaccelerometry

Outcome Measures

Primary Outcomes (1)

  • accelerations and acceleration based movement parameters

    1 time (1,5 -2 hours)

Study Arms (2)

1

EXPERIMENTAL

Healthy young 18-40years

Device: fall related movement (stumble) detector

2

EXPERIMENTAL

Healthy elderly

Device: fall related movement characteristic (stumble) detector

Interventions

fall related movement (stumble) detectorDEVICE

movement pattern (gait,balance) of young subjects recovery of a stumble in young subjects

1
fall related movement characteristic (stumble) detectorDEVICE

age related gait changes influencing movement pattern different pattern to recover from a trip

2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Maastricht

Maastricht, Limburg, 6200 MD, Netherlands

RECRUITING

Study Officials

  • kenneth Meijer, UD

    University Maastricht

    STUDY CHAIR

Central Study Contacts

Rachel Senden, dr

CONTACT

06 34023131rachel.senden@bw.unimaas.nl

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 2, 2008

Study Start

September 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

July 27, 2010

Record last verified: 2010-07

Locations

NL(1)