Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800470
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-02-22
Brief Title:
The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinsons Disease
Sponsor:
National Yang Ming Chiao Tung University
Organization:
National Yang Ming Chiao Tung University
Study Overview
Official Title:
The Novel Application of fNIRS-based Neurofeedback to Enhance Effects of Motor Imagery on Balance and Gait Performance in Individuals With Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Pearsons 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None