Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

Parkinsonism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064543
• Other study ID #: STU 072012-090
• Status: Completed
• Start date: July 2013
• Est. completion date: January 2017

Study information

• Verified date: September 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinsonian Disorders
• Parkinsonism

Intervention

Other:
• GAITRite
mobility test assessing gait parameters
• ADPM
mobility test assessing gait parameters

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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