The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title: The Novel Application of fNIRS-based Neurofeedback to Enhance Effects of Motor Imagery on Balance and Gait Performance in Individuals With Parkinson's Disease

Status Not yet recruiting

Clinical Trial Summary

A cross-sectional study (part 1) aims to investigate the influence of fatigue on the MI ability in PD compared to healthy controls. A randomized controlled trial (part 2) aims to compare the effect of fNIRS-based NFB-MI on balance and gait performance versus MI only in people with PD.

Clinical Trial Description

To fulfill out study purposes, a cross-sectional study (Part I) and an interventional randomized controlled trial (Part II) are designed. In Part I, people with PD and the age-matched healthy controls will be recruited and perform imagery and actual walking tasks. The level of general fatigue will be measured by Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) in people with PD. The level of concurrent fatigue will be induced by 30-minute cognitive tasks consisting of A-X continuous performance test, 2 back and mental rotation test and will be assessed by Brunel Mood Scale (BRUMS-C) in people with PD. Independent t test will be used to compare the MI ability between PD group and healthy control group. The Pearson's correlation coefficient will be used to examine the relationships between general fatigue level (MFI) and MI ability and between concurrent fatigue level (BRUMS) and MI ability in people with PD. In Part II, people with PD will be randomly allocated to either NFB-MI or MI group. Every participant will receive 12 sessions including three lab-visit sessions and nine home-bases training sessions. Each session consists of 10 min of MI, followed by 20 min of exercise focusing on balance and gait ability. During the lab-visit sessions, participants in experimental group will receive 10 minutes of NFB-MI. Outcome measures, including Mini Balance Evaluation Systems Test (Mini-BEST), Timed up-and-go test (TUG), gait performance, MI ability and fatigue, will be assessed at pre-, post-test, and follow-up. A two-way analysis of variance (ANOVA) with repeated measure will be used to determine the time by group interaction for all the outcomes. Post hoc test with Bonferroni correction will be applied for significant interaction. Significant level for part I and part II will be set at p < 0.05. ;

Related Conditions & MeSH terms

• Conversion Disorder
• Movement Disorders
• Parkinson Disease

• NCT number: NCT05800470
• Study type: Interventional
• Source: National Yang Ming Chiao Tung University
• Contact: Ray-Yau Wang
• Phone: +88628267210
• Email: rywang@nycu.edu.tw
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Completion date: August 1, 2025