Influencing Factors on Gait Variability in PD

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05109897
• Other study ID #: 2021-08-014B
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: National Yang Ming University
• Contact: Yea-Ru Yang, PhD
• Phone: 886228267279
• Email: yryang[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Taiwan	Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung 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	Gait variability	Using GAITRite system to measure coefficient of variation	10 minutes
Primary	Walking speed	Using GAITRite system to evaluate	10 minutes
Primary	Sensory organization test	Using NeuroCom Smart Balance Master to measure	20 minutes
Primary	Part III of the Unified Parkinson's Disease Rating Scale	The score ranged from 0 to 72. Higher scores show increased severity.	20 minutes
Primary	Tinetti Balance Scale	The score ranged from 0 to 28. Higher scores show better balance.	10 minutes
Primary	New freezing of gait questionnaire	The score ranged from 0 to 29. Higher scores show increased severity in freezing of gait.	15 minutes
Primary	Montreal Cognitive Assessment	The score ranged from 0 to 30. Higher scores show better cognitive function.	20 minutes