NCT01620021

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

June 12, 2012

Last Update Submit

May 6, 2015

Conditions

Gait Analysis

Keywords

wearable sensorskinematicsgait

Outcome Measures

Primary Outcomes (4)

  • gait speed

    60 seconds

  • stride length

    60 seconds

  • Torso motion

    60 seconds

  • Head motion

    60 seconds

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • no history of gait and balance issues

You may not qualify if:

  • younger than 18
  • older than 65
  • problems with gait and balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida Motion Analysis Laboratory

Tampa, Florida, 33620, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 15, 2012

Study Start

April 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

US(1)