Cognitive-motor Training for PD

The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.

This study will evaluate gait when individuals with Parkinson's disease (PD) are walking and how walking changes when challenged to perform a functional cognitive task simultaneously. By looking at walking alone and walking with varying cognitive loads the investigators will be able to determine motor and cognitive factors vulnerable to interference in PD. Each is important to understand so that training can address components of walking that become impaired when someone is distracted by a common cognitive task and so that the intensity of treatment matches the level of task difficulty. Using this initial data, the investigators will establish a protocol to improve walking taking into account the unique features of PD, including bradykinesia, freezing of gait, stiffness, and problems with memory and attention. The investigators will evaluate the potential for this treatment to improve walking and improve or maintain cognitive abilities necessary to multitask.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Identification of at risk variables; Behavioral: Gait-cognitive training

Detailed Description

In this study participants will be asked to participate in a training study to examine whether a new walking intervention that combines cognitive training with walking on a treadmill improves walking more than gait training or cognitive training alone. Participants with Parkinson's disease (PD) will come to the lab for a complete gait assessment using a motion analysis system that will record leg motion and muscle activity during comfortable walking. During the initial evaluation, participants will also complete cognitive assessments and surveys about community activities and quality of life related to PD. Participants will be divided into two training groups and asked to come to the lab three times a week for four weeks during the intervention. One week and one month after training, participants will return to the lab to complete all the same assessments that were performed during the initial visit. The results of the three testing sessions (initial, one week and one month) will be compared between and within groups to see if any of the interventions provided unique benefits to the health of persons with PD.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794-6018
      • Stony Brook University RRAMP Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease with our without cognitive impairment
• ambulatory for at least 200 feet without an assistive device (cane, walker, etc)

Exclusion Criteria:

• recent orthopedic injury (e.g., fracture, sprain, muscle pull, herniated disc)
• concurrent neurological illnesses including stroke, brain cancer, spinal cord injury, and diabetic neuropathies.
• cardiac insufficiency limiting ability to participate in walking study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Identification of at risk variables; Individuals will come in for a single visit to perform all tasks / conditions. Measurements will be taken of spatial and temporal features of walking with and without a secondary task. In addition, cognitive tests of memory and attention will be performed. Outcomes will narrow measures to those most likely to show clinically significant change.	Behavioral: Identification of at risk variables; Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive). Spatiotemporal measures of gait will be collected.
Experimental: Gait-Cognitive training; Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.	Behavioral: Gait-cognitive training; Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatiotemporal measures of gait across conditions and over time.	Changes in gait parameters are a key measure of the difficulty of performing two tasks at once. Decreases in gait speed, increased time in double support (two feet on the ground) and stopping while talking have been linked to increased disability and risk for falls.	Baseline testing at day one of study; follow-up testing at three time periods: 4-5 weeks after baseline (immediate post-training); 5-6 weeks (one week post-training); and 9-10 weeks after baseline (one month post-training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cognitive performance measured with serial sevens.	Participants will count backward by sevens from a digit between 90 and 100. The ability to perform the task will be used as a measure of cognitive trade-off relative to walking performance.	Baseline (day one); week 4-5 (immediate post 4 week training program); 5-6 weeks (one-week post-training); 9-10 weeks (one month post-training)

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Lisa M Muratori, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2020
• Primary Completion (Actual): December 17, 2021
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: memory; exercise; falls; walking; physical therapy; Parkinson's disease; attention; multitasking
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 64249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No