- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03406806
Gaitbox Validation Study
Comparison of the Gaitbox, SprintSystem Device and NIH Toolbox 4 Meter Walk
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GaitBox
|
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.
|
Active Comparator: Sprint System 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.
|
Active Comparator: NIH Toolbox 4 meter 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of 4 meter walk test
Time Frame: Up to 1 hour
|
Up to 1 hour
|
Speed of 4 meter walk test
Time Frame: Up to 1 hour
|
Up to 1 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Caves, ME, Duke University
Publications and helpful links
General Publications
- 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.
- 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.
- Lusardi, Michelle M. (2012). "Is Walking Speed a Vital Sign? Absolutely." Topics in geriatric rehabilitation 28(2): 67-76.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00089655
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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