Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

Measurement of Gait Using the Opal APDM and an Instrumented Gait Mat in Persons With Parkinsonism

The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who are able to provide informed consent will participate in the assessments.

Outcome variables include selected gait and balance parameters such as cadence, gait-cycle, stride-length, stride-velocity, turning duration, turning steps, postural sway and anticipatory postural control. These parameters will be measured by the portable inertial sensors developed by APDM® and the Zeno/GaitRite.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Testing

Participants after screening and consenting will:

  1. Have their height measured and fit with the APDM Opals (each device is a two inch square attached by velcro), one device is attached to each leg, each arm, and the trunk and chest and receive an introduction to walking on the gait mat.
  2. Participants are then asked to walk at a self selected walking speed down the gait mat. The participants will complete multiple passes (8-10 passes, total 75-100 feet) across the gait mat while wearing the APDM units to concurrently collect all temporal and spatial data needed to answer the research question. The Zeno mat is the intended primary gait mat for this study. The GaitRite will only be utilized in the case of a technical issue with the Zeno in order to insure completion of the data collection.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes and clinical signs of FoG

Description

Inclusion Criteria

  1. Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes
  2. Individuals able to walk 100 feet independently, with or without the use of an assistive device (walker, cane) and follow simple instructions.
  3. Individuals with sufficient physiological systemic support to participate in the study protocol

Exclusion Criteria

  1. Inability to speak English secondary to the need to understand and follow multistep directions
  2. A secondary diagnosis (musculoskeletal, cardiopulmonary, neurological) that excludes participation in the study
  3. Inability to ambulate 100 feet independently with or without an assistive device.
  4. Inability to follow simple instructions necessary for completion of the testing tasks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ADPM and GAITRite
mobility assessments (ADPM, GAITRite) measuring gait parameters
mobility test assessing gait parameters
mobility test assessing gait parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as cadence
one year
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as stride-length
one year
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as stride-velocity
one year
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as turning duration
one year
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as turning steps
one year
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as postural sway
one year
gait parameters
Time Frame: one year
Outcome variables include selected gait and balance such as anticipatory postural control
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pravin Khemani, M.D., UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Parkinsonism

Clinical Trials on GAITRite

Subscribe