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CompletedNCT03406806Updated Dec 10, 2018

Gaitbox Validation Study

An interventional study of Gaitbox and SprintSystem device in Validation of Gait Speed Device Against Existing Techniques, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-10.

Sponsored by Duke University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
55 Years and older
Sex
All
01

Study summary

The purpose of this study is to validate the walking velocity measured by the Gaitbox as compared to the measures obtained by clinicians administering the timed 4 meter walk test and the Sprint System device. The investigators have developed a compact device, the Gaitbox, which measures walking speed automatically. The device has an infrared light sensor that is capable to accurate distance measurements. To take a speed measurement, the device is placed at the end of the walking path and the subject simply walks towards the device. The device automatically records a starting and ending distance and calculates and displays walking speed in m/sec. This is a prospective, single site study. Up to 60 subjects will be enrolled at Duke. Subjects will be asked to complete the 4-meter walk test, three (3) times. Three speed measuring methods will be conducted simultaneously: NIH toolbox 4 meter clinic walk test and the Sprint System device (commercially available device typically used for timing track and field events), and the Gaitbox. The purpose is to validate the Gaitbox to the clinical NIH toolbox 4 meter test and against the Sprint System device. The following comparisons of speed will be made: Human timer 1 to human timer 2, Average human timer to Gaitbox, Gaitbox to Sprint System.

Read the detailed description

This is a prospective, single site study. Up to 60 subjects will be enrolled at Duke. Subjects will be asked to complete the 4-meter walk test, three (3) times. Three speed measuring methods will be conducted simultaneously: NIH toolbox 4 meter clinic walk test and the Sprint System device (commercially available device typically used for timing track and field events), and the Gaitbox.

NIH toolbox 4 meter clinic walk test: The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. Tape will be used to mark beginning and end of timing section of the walking path to allow for acceleration and deceleration. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to "Walk at a comfortable pace" and count down by saying: "3, 2, 1, go." The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log.

Simultaneously, the Sprint System will be operated according to manufacturers instructions. The device will be setup on tripods 4 feet from the floor so as to be triggered by the subject's torso rather than feet and set to measure data at the same distances as the gait box. The device will be set up to record times at the same distances as the Gaitbox. The Sprint System is used to time track running events by breaking two invisible light beams. Timing starts when the subject crosses the first line and stops when the second line is crossed. The times are displayed on a handheld display. Times will be transferred to the log sheet.

The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. To operate, investigator presses reset button, waits for ready light and tells subject to go. Speed is measured automatically and result is displayed. Times/speeds will be recorded on log sheet.

02

Conditions studied

  • Validation of Gait Speed Device Against Existing Techniques
03

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female subjects aged 55 or older
  • Subjects must be able to complete three 5 meter walks, with or without assistive device such as canes, crutches or walkers.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a physical, cognitive, or behavioral impairment that would prevent the safe completion of the testing, or affect the ability to follow study directions will be excluded from participation.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    GaitBox

    Other: Gaitbox

  • Active comparator
    Sprint System device

    Other: SprintSystem device

  • Active comparator
    NIH Toolbox 4 meter test

    Other: NIH toolbox 4 meter walk

Interventions

  • OtherGaitbox

    The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to "Walk at a comfortable pace" and count down by saying: "3, 2, 1, go." The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log. Simultaneously, the Sprint System \[6\] will be operated according to manufacturers instructions. The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. Times/speeds will be recorded on log sheet.

  • OtherSprintSystem device

    The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to "Walk at a comfortable pace" and count down by saying: "3, 2, 1, go." The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log. Simultaneously, the Sprint System \[6\] will be operated according to manufacturers instructions. The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. Times/speeds will be recorded on log sheet.

  • OtherNIH toolbox 4 meter walk

    The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to "Walk at a comfortable pace" and count down by saying: "3, 2, 1, go." The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log. Simultaneously, the Sprint System \[6\] will be operated according to manufacturers instructions. The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. Times/speeds will be recorded on log sheet.

05

What researchers measure

Primary outcomes

  1. Time of 4 meter walk test

    Time frame: Up to 1 hour

  2. Speed of 4 meter walk test

    Time frame: Up to 1 hour

06

Study locations

1 site
  • Duke University
    Durham, North Carolina 27705, United States
07

References and documents

Publications

  • Lusardi, Michelle M. (2012). "Is Walking Speed a Vital Sign? Absolutely." Topics in geriatric rehabilitation 28(2): 67-76.
  • Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221. PubMed 10811152 ↗
  • Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923. PubMed 21205966 ↗
  • Hardy SE, Perera S, Roumani YF, Chandler JM, Studenski SA. Improvement in usual gait speed predicts better survival in older adults. J Am Geriatr Soc. 2007 Nov;55(11):1727-34. doi: 10.1111/j.1532-5415.2007.01413.x. Epub 2007 Oct 3. PubMed 17916121 ↗
08

Registry details

Key details

Study ID
NCT03406806
Lead sponsor
Duke University
Collaborators
National Institute on Aging (NIA), National Institute on Disability, Independent Living, and Rehabilitation Research
Responsible party
Sponsor
First posted
Jan 23, 2018
Start date
Mar 14, 2018
Primary completion
Mar 14, 2018
Completion
Mar 14, 2018
Last update
Dec 10, 2018

Study contacts

Kevin Caves, ME
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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