Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346275
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-24
Brief Title:
Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex
Sponsor:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Organization:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study Overview
Official Title:
Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex Study Protocol for a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Background Alzheimers disease AD is characterized by cognitive impairment and behavioral impairment and increasing attention is paid in the gait of AD patients The aim of this randomized controlled trial RCT is to explore the effect of acupuncture on the cognitive function gait performance and hemodynamic changes in the prefrontal cortices
Methods In this RCT a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy fNIRS Secondary outcomes include Mini-Mental State Examination MMSE Montreal Cognitive Assessment MoCA and Barthel Index BI
Discussion This trial is expected to explore the effect of acupuncture on cognitive function gait performance and hemodynamic changes in the prefrontal cortices for AD patients
Methods In this RCT a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy fNIRS Secondary outcomes include Mini-Mental State Examination MMSE Montreal Cognitive Assessment MoCA and Barthel Index BI
Discussion This trial is expected to explore the effect of acupuncture on cognitive function gait performance and hemodynamic changes in the prefrontal cortices for AD patients
Detailed Description:
This study aims to assess the clinical effect of acupuncture on gait performance in AD patients and to examine the acupuncture effect on cerebral cortices by identifying hemodynamic changes that occur in the prefrontal cortices using the fNIRS technique
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