Clinical trial NCT02538029: The Effects of Dual Task Training in Individuals With Parkinson's Disease
Official title: The Effects of Dual Task Training on Motor and Non-Motor Function in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Dual tasking
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Davis Phinney Foundation
First posted: 2015-09-02
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic PD
* Able to provide informed consent
* Ability to ambulate ≥ 300ft with or without an assistive device
* Hoehn and Yahr stage 2-4

Exclusion Criteria:

* Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation
* Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire
* Musculoskeletal injury or neurological injury other than PD that would restrict physical activity
* Inability to follow 2 step commands
* Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire

Primary outcomes:
measure: Step Length During Gait
timeFrame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
measure: Walking Speed During Gait
timeFrame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Secondary outcomes:
measure: 2 Minute Walk Test
timeFrame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
measure: Quality of Life in Neurological Disorders Questionnaire
timeFrame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
measure: Trail Making Test
timeFrame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
measure: Reaction Time
timeFrame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jay Alberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penko AL, Barkley JE, Rosenfeldt AB, Alberts JL. Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease. J Phys Act Health. 2019 Dec 1;16(12):1085-1091. doi: 10.1123/jpah.2018-0595. Epub 2019 Oct 24.
citation: Rosenfeldt AB, Penko AL, Streicher MC, Zimmerman NM, Koop MM, Alberts JL. Improvements in temporal and postural aspects of gait vary following single- and multi-modal training in individuals with Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:280-285. doi: 10.1016/j.parkreldis.2019.05.021. Epub 2019 May 14.
citation: Rosenfeldt AB, Penko AL, Bazyk AS, Streicher MC, Dey T, Alberts JL. The Two Minute Walk Test Overground and on a Self-Paced Treadmill Detects Dual Task Deficits in Individuals With Parkinson's Disease. J Aging Phys Act. 2019 Dec 1;27(4):843-847. doi: 10.1123/japa.2018-0264.