Feasibility of Wearable Sensors to Determine Gait Parameters

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephanie L. Carey, University of South Florida
ClinicalTrials.gov Identifier:
NCT01620021
First received: June 12, 2012
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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

Condition
Gait Analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Feasibility of Wearable Sensors to Determine Gait Parameters

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • gait speed [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]
  • stride length [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]
  • Torso motion [ Time Frame: 60 seconds ] [ Designated as safety issue: No ]
  • Head motion [ Time Frame: 60 seconds ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: April 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • no history of gait and balance issues
  • 18-65

Exclusion Criteria:

  • younger than 18
  • older than 65
  • problems with gait and balance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620021

Locations
United States, Florida
University of South Florida Motion Analysis Laboratory
Tampa, Florida, United States, 33620
Sponsors and Collaborators
University of South Florida
  More Information

No publications provided

Responsible Party: Stephanie L. Carey, Assistant Research Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT01620021     History of Changes
Other Study ID Numbers: Pro00003205
Study First Received: June 12, 2012
Last Updated: July 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
wearable sensors
kinematics
gait

ClinicalTrials.gov processed this record on September 18, 2014