Influencing Factors on Gait Variability in PD

Influencing Factors and Improving Strategy on Gait Variability in People With Parkinson's Disease

The principal motor features of Parkinson's disease (PD) include rigidity, tremor, bradykinesia, and postural instability. These motor deficits might cause gait dysfunction including reduced gait velocity, stride length, arm swing, and increased gait variability. Among these, increase in gait variability increased fall risk and served as a marker of disease progression. Previous studies reported that some factors might influence gait variability. However, which one contributes most has not yet been verified. Therefore, the purpose of the present study is to identify the more related influencing factors on gait variability in people with PD.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yea-Ru Yang, PhD; Phone Number: 886228267279; Email: yryang@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People with Parkinson's disease

Description

Inclusion Criteria:

• Idiopathic PD
• Hoehn and Yahr stages I through III
• Ability to stand and walk 5 m independently with or without any walking aids
• Stable medication usage

Exclusion Criteria:

• Unstable medical conditions
• Any neurological, cardiopulmonary or orthopedic problem/diseases that may interfere with participating the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait variability	Using GAITRite system to measure coefficient of variation	10 minutes
Walking speed	Using GAITRite system to evaluate	10 minutes
Sensory organization test	Using NeuroCom Smart Balance Master to measure	20 minutes
Part III of the Unified Parkinson's Disease Rating Scale	The score ranged from 0 to 72. Higher scores show increased severity.	20 minutes
Tinetti Balance Scale	The score ranged from 0 to 28. Higher scores show better balance.	10 minutes
New freezing of gait questionnaire	The score ranged from 0 to 29. Higher scores show increased severity in freezing of gait.	15 minutes
Montreal Cognitive Assessment	The score ranged from 0 to 30. Higher scores show better cognitive function.	20 minutes

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson's disease, Gait variability
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2021-08-014B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No