- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02064543
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
Detailed Description
Testing
Participants after screening and consenting will:
- 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.
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
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Dallas, Texas, United States, 75390
- UT Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria
- Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes
- Individuals able to walk 100 feet independently, with or without the use of an assistive device (walker, cane) and follow simple instructions.
- Individuals with sufficient physiological systemic support to participate in the study protocol
Exclusion Criteria
- Inability to speak English secondary to the need to understand and follow multistep directions
- A secondary diagnosis (musculoskeletal, cardiopulmonary, neurological) that excludes participation in the study
- Inability to ambulate 100 feet independently with or without an assistive device.
- 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
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
Investigators
- Principal Investigator: Pravin Khemani, M.D., UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 072012-090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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