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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662009
• Other study ID #: 2017-045
• Secondary ID: 1R15NS098340-01A
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2022
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• multilimb dual task
control of arm and foot in two attentional contexts of simulated driving

Locations

Country	Name	City	State
United States	A.T. Still University Arizona School of Health Sciences	Mesa	Arizona

Sponsors (4)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences	Mayo Clinic, National Institute of Neurological Disorders and Stroke (NINDS), University of Idaho

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.