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CompletedNCT02064543Updated Sep 18, 2019

Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

An observational study in Parkinsonism, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-18.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.
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Conditions studied

  • Parkinsonism

Keywords

  • Parkinson's disease
  • gait
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In context

Parkinsonian Disorders

235 studies on the registry are indexed under Parkinsonian Disorders; 69 are open to participants now.

This study's enrollment of 24 is below the median of 150 across 81 observational studies indexed under Parkinsonian Disorders.

Browse Parkinsonian Disorders studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Groups and cohorts

  • ADPM and GAITRite

    mobility assessments (ADPM, GAITRite) measuring gait parameters

    Other: GAITRite · Other: ADPM

Interventions

  • OtherGAITRite

    mobility test assessing gait parameters

  • OtherADPM

    mobility test assessing gait parameters

06

What researchers measure

Primary outcomes

  1. gait parameters

    Outcome variables include selected gait and balance such as cadence

    Time frame: one year

  2. gait parameters

    Outcome variables include selected gait and balance such as stride-length

    Time frame: one year

  3. gait parameters

    Outcome variables include selected gait and balance such as stride-velocity

    Time frame: one year

  4. gait parameters

    Outcome variables include selected gait and balance such as turning duration

    Time frame: one year

  5. gait parameters

    Outcome variables include selected gait and balance such as turning steps

    Time frame: one year

  6. gait parameters

    Outcome variables include selected gait and balance such as postural sway

    Time frame: one year

  7. gait parameters

    Outcome variables include selected gait and balance such as anticipatory postural control

    Time frame: one year

07

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02064543
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
Feb 17, 2014
Start date
Jul 2013
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Sep 18, 2019

Study contacts

Pravin Khemani, M.D.
principal investigator · UT Southwestern Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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