Clinical trial NCT02064543: Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism
Official title: Measurement of Gait Using the Opal APDM and an Instrumented Gait Mat in Persons With Parkinsonism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinsonism
Keywords: Parkinson's disease
gait
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: gait parameters
timeFrame: one year
measure: gait parameters
timeFrame: one year
measure: gait parameters
timeFrame: one year
measure: gait parameters
timeFrame: one year
measure: gait parameters
timeFrame: one year
measure: gait parameters
timeFrame: one year
measure: gait parameters
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Pravin Khemani, M.D.
role: PRINCIPAL_INVESTIGATOR
References: