Interactive Stepping Exercise on Balance and Cognitive Function

Overview

The objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals with PD.

Full Title of Study: “Effects of Interactive Stepping Exercise on Balance and Cognitive Function in Individuals With Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2021

Interventions

  • Other: Interactive stepping exercise
    • An exercise intervention based on the principle of square stepping exercise
  • Other: Square stepping exercise
    • Square stepping exercise

Arms, Groups and Cohorts

  • Experimental: Interactive stepping exercise group
    • Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).
  • Active Comparator: Square stepping exercise group
    • Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).

Clinical Trial Outcome Measures

Primary Measures

  • Romberg test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate static balance ability
  • Sharpened Romberg test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate static balance ability
  • One-leg stance test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate static balance ability
  • Timed up and go test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate functional walking ability
  • Mini-Balance Evaluation Systems Test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate balance ability
  • Montreal Cognitive Assessment Chinese version
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate global cognitive function
  • Digit span test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate executive function
  • Stroop color and word test Chinese version
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate executive function
  • Trail-making test Chinese version
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate executive function
  • Spatial span test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate visuospatial ability

Secondary Measures

  • 10-meter walk test
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate walking ability
  • Parkinson’s Disease Questionnaire 39
    • Time Frame: Change from baseline at 8 weeks and 12 weeks
    • To evaluate the quality of life

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Yang Ming University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yea-Ru Yang, Professor – National Yang Ming University
  • Overall Contact(s)
    • Yea-Ru Yang, PhD, +886-2-28267279, yryang@ym.edu.tw

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