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

February 4, 2022 updated by: Tara McIsaac, A.T. Still University of Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • A.T. Still University Arizona School of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals will be recruited through collaboration with hospitals, clinics, physical therapy centers, private practice physicians and physical therapists, neurology-based fitness centers, community centers, PD support groups, online trial-matching services (e.g., FoxTrialFinder.michaeljfox.org), word of mouth, and advertising. Recruitment will be limited to the greater Phoenix metropolitan area.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson Disease
Observation of individuals with idiopathic Parkinson disease performing a multilimb dual task using the arm and the leg.
Other: multilimb dual task
control of arm and foot in two attentional contexts of simulated driving
Other Names:
  • Instructed priority
  • constrained accuracy
Control
Observation of healthy age-matched individuals will perform a multilimb dual task using the arm and the leg.
Other: multilimb dual task
control of arm and foot in two attentional contexts of simulated driving
Other Names:
  • Instructed priority
  • constrained accuracy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.T. Still University of Health Sciences

Collaborators

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

Investigators

  • Principal Investigator: Tara L McIsaac, PhD, PT, A.T. Still University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-045
  • 1R15NS098340-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is not yet known if there will be a plan to make IPD available. Institutional infrastructure being developed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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