Validation of Gait Speed Device Against Existing TechniquesNCT03406806
Gaitbox Validation Study
A study testing Gaitbox, SprintSystem device and NIH toolbox 4 meter walk in people with Validation of Gait Speed Device Against Existing Techniques, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Validation of Gait Speed Device Against Existing Techniques
- What is being tested?
- Gaitbox, SprintSystem device and NIH toolbox 4 meter walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 14 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Gaitbox, SprintSystem Device and NIH Toolbox 4 Meter Walk
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.
- Being tested
- Gaitbox, SprintSystem device, NIH toolbox 4 meter walk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaitboxOther
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.
SprintSystem deviceOther
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.
NIH toolbox 4 meter walkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GaitBox | Experimental | Not described Receives: Other: Gaitbox |
| Sprint System device | Active comparator | Not described Receives: Other: SprintSystem device |
| NIH Toolbox 4 meter test | Active comparator | Not described Receives: Other: NIH toolbox 4 meter walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of 4 meter walk test
Measured: Up to 1 hour
Speed of 4 meter walk test
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start14 Mar 2018
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Validation of Gait Speed Device Against Existing TechniquesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Kevin Caves, ME, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406806
- Sponsor's protocol ID
- Pro00089655
- Status last verified
- Mar 2018
- First submitted
- 16 Jan 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 10811152Studenski 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 21205966Hardy 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Gaitbox, SprintSystem Device and NIH Toolbox 4 Meter Walk
- ClinicalTrials.gov ID
- NCT03406806
- Acronym / sponsor ID
- Pro00089655
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GaitBox | Experimental | Other: Gaitbox |
| Sprint System device | Active comparator | Other: SprintSystem device |
| NIH Toolbox 4 meter test | Active comparator | Other: NIH toolbox 4 meter walk |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaitboxThe 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. | Other | GaitBox |
| SprintSystem deviceThe 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. | Other | Sprint System device |
| NIH toolbox 4 meter walkThe 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. | Other | NIH Toolbox 4 meter test |
Primary outcome
Time of 4 meter walk test
Time frame: Up to 1 hour
Speed of 4 meter walk test
Time frame: Up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- BackgroundLusardi, Michelle M. (2012). "Is Walking Speed a Vital Sign? Absolutely." Topics in geriatric rehabilitation 28(2): 67-76.
- Background: PubMed 10811152Guralnik 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.
- Background: PubMed 21205966Studenski 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.
- Background: PubMed 17916121Hardy 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.
- NIH Toolbox: Assessment of Neurological and Behavioral FunctionLink provided by the sponsor.
- Sprint systemLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Caves, ME principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaitbox, SprintSystem device and NIH toolbox 4 meter walk in people with Validation of Gait Speed Device Against Existing Techniques, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of 4 meter walk test (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406806, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.