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: Parkinsonism
• Intervention / Treatment: Other: GAITRite; Other: ADPM

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Pravin Khemani, M.D., UT southwestern Medical Center

Study record dates

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

• Keywords: gait; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Parkinsonian Disorders
• Other Study ID Numbers: STU 072012-090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No