- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620021
Feasibility of Wearable Sensors to Determine Gait Parameters
Hypotheses:
• A wearable sensor system can be used to accurately monitor three common gait parameters: gait speed, stride length, and torso motion.
Objectives:
This study will examine the feasibility of using wearable sensors to monitor common gait parameters: gait speed, stride length and torso motion. A wearable sensor system of 8 commercially available inertial measurement units (IMU) will be composed. These sensors will work in unison to monitor the gait parameters.
Technical Objectives
- Gather information on commercially available IMUs
- Use computer software to monitor and record data from IMUs
- Develop an algorithm that can monitor volunteer gait speed, stride length and torso motion
- Develop a graphical algorithm that compares healthy patient data to potential mild traumatic brain injury (mTBI ) candidates
- Determine if there is a potential for mTBI determination using the wearable sensors
- Accurately validate the wearable sensor system to the gait parameters measured using a Vicon motion analysis system
Study Overview
Status
Conditions
Detailed Description
This study will examine the feasibility of using wearable sensors to monitor common gait parameters. A sensor system consisting of 8 wearable inertial measurement units (IMU) that include accelerometers, gyroscopes and magnetometers will be examined. These sensors will be programmed to work in unison to monitor gait parameters. The wearable sensor suite will have the capability to collect and store gait parameter data. The size and weight of each sensor should be similar to a standard metal wrist watch. The sensor suite will monitor three gait parameters: gait speed, stride length, and torso motion. These gait parameters are important for monitoring and detection of mild traumatic brain injury and as well as other neurological and vestibular disorders.
The wearable sensor suite will have the following design parameters:
- Devices must be able to both stream data real-time and record data onboard for later transfer to a computer.
- Data must be processed using a software analysis package such as MATLAB®
- Device must be no heavier than the size of a metal wrist watch
- Device must be easily put on and be easily operated by clinicians and users
- Device must have a battery life of greater than 4 hours The wearable sensor suite will then be validated using an eight camera Vicon infrared optical capture motion analysis system for comparison. Ten healthy volunteers will be asked to complete four different types of gait trials 5 times for each trial type while being monitored by the Vicon motion analysis system and the wearable sensor system.
The types of gait trials will be the following:
- Walk down a 20 ft path at self-selected normal stride length and cadence
- Walk down a 20 ft path with increased stride length while decreasing gait speed
- Walk down a 20 ft path with increased stride length while increasing gait speed
- Walk down a 20 ft path with decreased stride length while decreasing gait speed
- Walk down a 20 ft path with decreased stride length while increasing gait speed
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Tampa, Florida, United States, 33620
- University of South Florida Motion Analysis Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- no history of gait and balance issues
- 18-65
Exclusion Criteria:
- younger than 18
- older than 65
- problems with gait and balance
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Healthy
Ten healthy volunteers with no history of gait and balance issues will be recruited to participate in the study.The participants must be between 18 and 65 years of age.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
gait speed
Time Frame: 60 seconds
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60 seconds
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stride length
Time Frame: 60 seconds
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60 seconds
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Torso motion
Time Frame: 60 seconds
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60 seconds
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Head motion
Time Frame: 60 seconds
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60 seconds
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00003205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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