Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex (NCT06346275) | Clinical Trial Compass
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 range40 Years – 85 Years
SexALL
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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
✕. 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);
✕
What they're measuring
1
Three-dimensional gait analysis
Timeframe: Assessments will be performed before the treatments, at 4 weeks after treatments, and at 8 weeks after treatments.
2
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
. 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.