Clinical trial NCT03662009: Multi-limb Dual-task Control in Parkinson's Disease
Official title: Multi-limb Control in Parkinson's Disease: Implicit and Explicit Control of Attention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Idaho
name: Mayo Clinic
First posted: 2018-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dual Task Effect on Arm and Foot Tasks
timeFrame: Subjects with PD: Two 90-minute sessions within a week; Healthy controls: One 90-minute session, observation of simulated driving.
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: A.T. Still University Arizona School of Health Sciences
state: Arizona
Study officials:
affiliation: A.T. Still University
name: Tara L McIsaac, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.