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Cognitive-motor Training for PD

Primary Purpose

Parkinson's Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gait-cognitive training
Identification of at risk variables
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring walking, Parkinson's disease, physical therapy, falls, memory, attention, multitasking, exercise

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stony Brook University RRAMP Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Identification of at risk variables

Gait-Cognitive training

Arm Description

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.

Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 30, 2013
Last Updated
January 14, 2022
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT01917903
Brief Title
Cognitive-motor Training for PD
Official Title
The Effects of Dual Task Treadmill Training on Gait and Cognition in Individuals With Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 17, 2021 (Actual)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
walking, Parkinson's disease, physical therapy, falls, memory, attention, multitasking, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
Assessments are performed by a clinician blinded to participant group (training vs. waitlist control) allocation.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Identification of at risk variables
Arm Type
Experimental
Arm Description
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.
Arm Title
Gait-Cognitive training
Arm Type
Experimental
Arm Description
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
Intervention Type
Behavioral
Intervention Name(s)
Gait-cognitive training
Intervention Description
Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
Intervention Type
Behavioral
Intervention Name(s)
Identification of at risk variables
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spatiotemporal measures of gait across conditions and over time.
Description
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.
Time Frame
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 Measure Information:
Title
Changes in cognitive performance measured with serial sevens.
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Muratori
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University RRAMP Laboratory
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-6018
Country
United States

12. IPD Sharing Statement

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Cognitive-motor Training for PD

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