NCT03662009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

August 30, 2018

Last Update Submit

February 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dual Task Effect on Arm and Foot Tasks

    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.

Study Arms (2)

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

Observation of healthy age-matched individuals will perform a multilimb dual task using the arm and the leg.

Other: multilimb dual task

Interventions

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

Also known as: Instructed priority, constrained accuracy
ControlParkinson Disease

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.T. Still University Arizona School of Health Sciences

Mesa, Arizona, 85206, United States

Location

Related Publications (3)

  • McIsaac TL, Benjapalakorn B. Allocation of attention and dual-task effects on upper and lower limb task performance in healthy young adults. Exp Brain Res. 2015 Sep;233(9):2607-17. doi: 10.1007/s00221-015-4333-6. Epub 2015 Jun 17.

    PMID: 26080755BACKGROUND
  • McIsaac TL, Lamberg EM, Muratori LM. Building a framework for a dual task taxonomy. Biomed Res Int. 2015;2015:591475. doi: 10.1155/2015/591475. Epub 2015 Apr 19.

    PMID: 25961027BACKGROUND
  • Thompson T, Poulter D, Miles C, Solmi M, Veronese N, Carvalho AF, Stubbs B, Uc EY. Driving impairment and crash risk in Parkinson disease: A systematic review and meta-analysis. Neurology. 2018 Sep 4;91(10):e906-e916. doi: 10.1212/WNL.0000000000006132. Epub 2018 Aug 3.

    PMID: 30076275BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Tara L McIsaac, PhD, PT

    A.T. Still University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 7, 2018

Study Start

September 1, 2017

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

February 7, 2022

Record last verified: 2022-02

Locations