UnknownNot Applicable

Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex

108 participantsStarted 2024-07-01

Plain-language summary

Background: Alzheimer's 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 40-85 years old;
. Meeting the mentioned-above diagnostic criteria from traditional Chinese medicine and Western medicine;
. With mild to moderate dementia (CDR=0.5, 1.0, or 2.0 points);
. Hachinski Ischemic Scale (HIS) ≤ 4 points;
. Hamilton Depression Rating Scale (HAMD) \< 20 points;
. Without severe bone and joint diseases and able to walk independently;
. Able to conduct vision and hearing tests;

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Three-dimensional gait analysis

Timeframe: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

Cerebral hemodynamics

Timeframe: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

Trial details

NCT IDNCT06346275

SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 40-85 years old;
. Meeting the mentioned-above diagnostic criteria from traditional Chinese medicine and Western medicine;
. With mild to moderate dementia (CDR=0.5, 1.0, or 2.0 points);
. Hachinski Ischemic Scale (HIS) ≤ 4 points;
. Hamilton Depression Rating Scale (HAMD) \< 20 points;
. Without severe bone and joint diseases and able to walk independently;
. Able to conduct vision and hearing tests;

Exclusion criteria

What they're measuring

Three-dimensional gait analysis

Timeframe: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.

Cerebral hemodynamics

Timeframe: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.