search
Back to results

Dual-task Performance in Young-onset PD

Primary Purpose

Early Onset Parkinson Disease, Early Stage Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Game based dual-task training
Treadmill training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Onset Parkinson Disease focused on measuring Executive function, Dual-task performance, Dual-task training

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed as PD and Hoehn and Yahr stage between 1~3
  • Age between 20 to 80
  • Able to walk 10 m independently without an assistive device
  • A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
  • In stable medical condition allowing participation in the testing protocol and intervention

Exclusion Criteria:

  • Any comorbidity or disability other than PD that would preclude gait training
  • Any uncontrolled health condition for which exercise was contraindicated
  • Any neurological or orthopedic disease that might interfere with the study
  • Server freezing of gait, FOG questionnaire > 15

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Game based dual-task training group

    Treadmill training group

    Arm Description

    Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks

    Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks

    Outcomes

    Primary Outcome Measures

    Dual-task walking performance
    To evaluate gait parameters while doing dual-task walking

    Secondary Outcome Measures

    Single walking performance
    To evaluate gait parameters while doing single walking
    Timed up and go test
    To evaluate functional walking ability
    Parkinson's Disease Questionnaire 39
    To evaluate the quality of life
    Frontal lobe battery test-Chinese version
    To evaluate executive function
    Trail-making test
    To evaluate executive function
    Stroop color and word test-Chinese version
    To evaluate executive function
    Verbal fluency test-Chinese version
    To evaluate executive function
    Digit span test
    To evaluate executive function
    Dual-task costs
    To compare the cost between doing dual task and single task
    Functional near-infrared spectroscopy
    To evaluate the changes of blood perfusion in frontal lobe

    Full Information

    First Posted
    July 24, 2019
    Last Updated
    July 25, 2019
    Sponsor
    National Yang Ming University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04033393
    Brief Title
    Dual-task Performance in Young-onset PD
    Official Title
    Decrement of the Dual-task Performance in Individuals With Young-onset Parkinson's Disease and the Training Effects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    July 31, 2022 (Anticipated)
    Study Completion Date
    July 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Yang Ming University

    4. Oversight

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

    5. Study Description

    Brief Summary
    This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Early Onset Parkinson Disease, Early Stage Parkinson Disease
    Keywords
    Executive function, Dual-task performance, Dual-task training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Game based dual-task training group
    Arm Type
    Experimental
    Arm Description
    Participants in dual-task training group will execute game based dual-task training with treadmill, 3 times per week for 8 weeks
    Arm Title
    Treadmill training group
    Arm Type
    Active Comparator
    Arm Description
    Participants in treadmill training group will do treadmill training, 3 times per week for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Game based dual-task training
    Intervention Description
    Participants in the experimental group will receive game based dual-task training with a treadmill
    Intervention Type
    Other
    Intervention Name(s)
    Treadmill training
    Intervention Description
    Participants in the control group will receive treadmill training
    Primary Outcome Measure Information:
    Title
    Dual-task walking performance
    Description
    To evaluate gait parameters while doing dual-task walking
    Time Frame
    Change from baseline at 8 weeks
    Secondary Outcome Measure Information:
    Title
    Single walking performance
    Description
    To evaluate gait parameters while doing single walking
    Time Frame
    Change from baseline at 8 weeks
    Title
    Timed up and go test
    Description
    To evaluate functional walking ability
    Time Frame
    Change from baseline at 8 weeks
    Title
    Parkinson's Disease Questionnaire 39
    Description
    To evaluate the quality of life
    Time Frame
    Change from baseline at 8 weeks
    Title
    Frontal lobe battery test-Chinese version
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 8 weeks
    Title
    Trail-making test
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 8 weeks
    Title
    Stroop color and word test-Chinese version
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 8 weeks
    Title
    Verbal fluency test-Chinese version
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 8 weeks
    Title
    Digit span test
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 8 weeks
    Title
    Dual-task costs
    Description
    To compare the cost between doing dual task and single task
    Time Frame
    Change from baseline at 8 weeks
    Title
    Functional near-infrared spectroscopy
    Description
    To evaluate the changes of blood perfusion in frontal lobe
    Time Frame
    Change from baseline at 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as PD and Hoehn and Yahr stage between 1~3 Age between 20 to 80 Able to walk 10 m independently without an assistive device A score of greater than or equal to 24 on the mini-mental state examination (MMSE) In stable medical condition allowing participation in the testing protocol and intervention Exclusion Criteria: Any comorbidity or disability other than PD that would preclude gait training Any uncontrolled health condition for which exercise was contraindicated Any neurological or orthopedic disease that might interfere with the study Server freezing of gait, FOG questionnaire > 15
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Yearu, Ph.D.
    Phone
    +88628267279
    Email
    yryang@ym.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Dual-task Performance in Young-onset PD

    We'll reach out to this number within 24 hrs