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OpenTrials
Completed

NCT Number: NCT03662009

Multi-limb Dual-task Control in Parkinson's Disease

People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Through understanding the impact of Parkinson disease on mechanisms underlying attention and multi-limb control, training and rehabilitation programs can better focus on the needs of drivers with Parkinson disease. The proposed study aims to address this need by taking measures of simulated driving at one point in time. Subjects with PD are tested at a single time point when they are at their "best" point in their day and on another day when they are at their worst and are about to take their next dose of medication. Healthy age-matched subjects are not taking anti-parkinson medication so are tested at only one point.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.T. Still University Arizona School of Health Sciences

Mesa, Arizona, 85206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have a clinical diagnosis of mild to moderate idiopathic PD (Hoehn & Yahr stages 1-3),
  • hold a valid driver's license and drive at least once a week, and
  • be capable of providing informed consent and complying with study procedures. Control group participants will be healthy, neurologically intact individuals, age-matched to within 2 years of the PD subjects.

Exclusion criteria

  • impaired global cognition (i.e., a score of < 20 on the Montreal Cognitive Assessment (MoCA) screening tool)
  • sensory loss in the lower limb as assessed by clinical test of vibration perception at the ankle,
  • orthopedic, visual, or neurological conditions that would prevent performance of the experimental tasks,
  • inability to complete and pass the assessment testing,
  • history of neurological illness such as head trauma, previous stroke, epilepsy, demyelinating disease, or
  • complicating medical problems such as diabetes.

Treatment and study plan

multilimb dual task

Other

control of arm and foot in two attentional contexts of simulated driving

Other names: Instructed priority, constrained accuracy

Primary outcomes

  1. Dual Task Effect on Arm and Foot Tasks

    Time frame: Subjects with PD: Two 90-minute sessions within a week; Healthy controls: One 90-minute session, observation of simulated driving.

    The Dual Task Effect is the performance measure of the arm and foot task, respectively, in the dual task relative to the single task, expressed as a percentage.

Sponsors and collaborators

Lead sponsor

A.T. Still University of Health Sciences

Other

Collaborators

  • Mayo Clinic
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • University of Idaho

Registry information

Official study title

Multi-limb Control in Parkinson's Disease: Implicit and Explicit Control of Attention

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2018
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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