Interactive Stepping Exercise on Balance and Cognitive Function

August 25, 2020 updated by: Yea-Ru Yang, National Yang Ming University

Effects of Interactive Stepping Exercise on Balance and Cognitive Function in Individuals With Parkinson's Disease

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Yang-Ming University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive stepping exercise group
Participants will execute interactive stepping exercise 2 times per week for 8 weeks (16 sessions).
Other: Interactive stepping exercise
An exercise intervention based on the principle of square stepping exercise
Active Comparator: Square stepping exercise group
Participants will execute square stepping exercise 2 times per week for 8 weeks (16 sessions).
Other: Square stepping exercise
Square stepping exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 31, 2020

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YM109104F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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