Interactive Stepping Exercise on Balance and Cognitive Function

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494906
• Other study ID #: YM109104F
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: National Yang Ming University
• Contact: Yea-Ru Yang, PhD
• Phone: +886-2-28267279
• Email: yryang[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Romberg test	To evaluate static balance ability	Change from baseline at 8 weeks and 12 weeks
Primary	Sharpened Romberg test	To evaluate static balance ability	Change from baseline at 8 weeks and 12 weeks
Primary	One-leg stance test	To evaluate static balance ability	Change from baseline at 8 weeks and 12 weeks
Primary	Timed up and go test	To evaluate functional walking ability	Change from baseline at 8 weeks and 12 weeks
Primary	Mini-Balance Evaluation Systems Test	To evaluate balance ability	Change from baseline at 8 weeks and 12 weeks
Primary	Montreal Cognitive Assessment Chinese version	To evaluate global cognitive function	Change from baseline at 8 weeks and 12 weeks
Primary	Digit span test	To evaluate executive function	Change from baseline at 8 weeks and 12 weeks
Primary	Stroop color and word test Chinese version	To evaluate executive function	Change from baseline at 8 weeks and 12 weeks
Primary	Trail-making test Chinese version	To evaluate executive function	Change from baseline at 8 weeks and 12 weeks
Primary	Spatial span test	To evaluate visuospatial ability	Change from baseline at 8 weeks and 12 weeks
Secondary	10-meter walk test	To evaluate walking ability	Change from baseline at 8 weeks and 12 weeks
Secondary	Parkinson's Disease Questionnaire 39	To evaluate the quality of life	Change from baseline at 8 weeks and 12 weeks