Feasibility of Wearable Sensors to Determine Gait Parameters

Gait Analysis Clinical Trial

Official title:

Feasibility of Wearable Sensors to Determine Gait Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620021
• Other study ID #: Pro00003205
• Status: Completed
• Phase: N/A
• First received: June 12, 2012
• Last updated: May 6, 2015
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gait Analysis

Locations

Country	Name	City	State
United States	University of South Florida Motion Analysis Laboratory	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait speed		60 seconds	No
Primary	stride length		60 seconds	No
Primary	Torso motion		60 seconds	No
Primary	Head motion		60 seconds	Yes