Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex: Study Protocol for a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 108
- Primary Endpoint
- Three-dimensional gait analysis
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The inclusion criteria are as follows:
- •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;
- •Volunteering to participate in this trial and signing an informed consent form.
Exclusion Criteria
- •The exclusion criteria are as follows:
- •Dementia caused by other systemic or neurological diseases, such as central nervous system infections, post-traumatic dementia, Parkinson's disease dementia;
- •Suffering from acute illness, upper limb extrapyramidal stiffness, neurological or psychiatric disorders (except cognitive impairment);
- •With medical history that interferes with cognitive function assessment, such as past history of psychiatric drug abuse, drug addiction within the past 5 years, and alcohol abuse;
- •Afraid of acupuncture and cannot accept acupuncture treatment;
- •Currently participating in other clinical trial that affects the outcome evaluation of this trial.
Arms & Interventions
Control group
Cognitive rehabilitation therapy: The cognitive training system (JZ-RZ-1020, Extreme Medical Technology, Hangzhou, China) will be used to help develop personalized rehabilitation plans for one-on-one training based on the cognitive function of each patient. The trainings include memory, hand eye reinforcement, attention, reaction. Patients are treated for 30 minutes each time and 5 times a week for 8 weeks.
Intervention: Acupuncture (Procedure)
Acupuncture group
Acupoints: Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Taixi (KI3), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), and Shenmen (HT7).
Intervention: Acupuncture (Procedure)
Outcomes
Primary Outcomes
Three-dimensional gait analysis
Time Frame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
Vicon's Nexus system detects gait parameters and kinematic parameters, including step length, stride, pace, step width, step frequency, single/double stand phase, turning (time and number of steps required for turning), swing phase.
Cerebral hemodynamics
Time Frame: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
A total of 22 channels are configured using 8 emitters and 8 detectors, with each light source emitting three wavelengths (780 nm, 805 nm, and 830 nm) of light, and the original intensity signal is recorded at a sampling frequency of 13.33Hz. Patients need to try to keep the head fixed during the walking.
Secondary Outcomes
- Montreal Cognitive Assessment(Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.)
- Mini-Mental State Examination(Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.)
- Barthel Index(Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.)
Investigators
Zhenmei Hong
Principal Investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University