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Interactive Stepping Exercise on Balance and Cognitive Function

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Interactive stepping exercise
Square stepping exercise
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Interactive stepping exercise, Square stepping exercise, Parkinson's disease, Balance ability, Cognitive function

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Idiopathic PD
  • Hoehn & Yahr stage between 1 to 3
  • Age between 50 to 85
  • Stable pharmacologic treatment for the last 2 weeks
  • Ability to walk 10 meters unassisted or with assistive devices

Exclusion Criteria:

  • Other neurological disorders diagnosis than PD
  • Receiving any neurological surgeries
  • Any musculoskeletal disorder or cardiopulmonary disease that may influence participation in the study
  • The Mini-Mental State Examination (MMSE) < 24 scores
  • Participated in other exercise intervention of study in the past 3 months
  • Colorblindness or color vision deficiency

Sites / Locations

  • National Yang-Ming UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interactive stepping exercise group

Square stepping exercise group

Arm Description

Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).

Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).

Outcomes

Primary Outcome Measures

Romberg test
To evaluate static balance ability
Sharpened Romberg test
To evaluate static balance ability
One-leg stance test
To evaluate static balance ability
Timed up and go test
To evaluate functional walking ability
Mini-Balance Evaluation Systems Test
To evaluate balance ability
Montreal Cognitive Assessment Chinese version
To evaluate global cognitive function
Digit span test
To evaluate executive function
Stroop color and word test Chinese version
To evaluate executive function
Trail-making test Chinese version
To evaluate executive function
Spatial span test
To evaluate visuospatial ability

Secondary Outcome Measures

10-meter walk test
To evaluate walking ability
Parkinson's Disease Questionnaire 39
To evaluate the quality of life

Full Information

First Posted
July 28, 2020
Last Updated
August 25, 2020
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04494906
Brief Title
Interactive Stepping Exercise on Balance and Cognitive Function
Official Title
Effects of Interactive Stepping Exercise on Balance and Cognitive Function in Individuals With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (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
The objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals 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
Interactive stepping exercise, Square stepping exercise, Parkinson's disease, Balance ability, Cognitive function

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
Interactive stepping exercise group
Arm Type
Experimental
Arm Description
Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).
Arm Title
Square stepping exercise group
Arm Type
Active Comparator
Arm Description
Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).
Intervention Type
Other
Intervention Name(s)
Interactive stepping exercise
Intervention Description
An exercise intervention based on the principle of square stepping exercise
Intervention Type
Other
Intervention Name(s)
Square stepping exercise
Intervention Description
Square stepping exercise
Primary Outcome Measure Information:
Title
Romberg test
Description
To evaluate static balance ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Sharpened Romberg test
Description
To evaluate static balance ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
One-leg stance test
Description
To evaluate static balance ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Timed up and go test
Description
To evaluate functional walking ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Mini-Balance Evaluation Systems Test
Description
To evaluate balance ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Montreal Cognitive Assessment Chinese version
Description
To evaluate global cognitive function
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Digit span test
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Stroop color and word test Chinese version
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Trail-making test Chinese version
Description
To evaluate executive function
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Spatial span test
Description
To evaluate visuospatial ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
10-meter walk test
Description
To evaluate walking ability
Time Frame
Change from baseline at 8 weeks and 12 weeks
Title
Parkinson's Disease Questionnaire 39
Description
To evaluate the quality of life
Time Frame
Change from baseline at 8 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic PD Hoehn & Yahr stage between 1 to 3 Age between 50 to 85 Stable pharmacologic treatment for the last 2 weeks Ability to walk 10 meters unassisted or with assistive devices Exclusion Criteria: Other neurological disorders diagnosis than PD Receiving any neurological surgeries Any musculoskeletal disorder or cardiopulmonary disease that may influence participation in the study The Mini-Mental State Examination (MMSE) < 24 scores Participated in other exercise intervention of study in the past 3 months Colorblindness or color vision deficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ru Yang, PhD
Phone
+886-2-28267279
Email
yryang@ym.edu.tw
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ru Yang, PhD
Phone
886-2-28267279
Email
yryang@ym.edu.tw

12. IPD Sharing Statement

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Interactive Stepping Exercise on Balance and Cognitive Function

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