The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke

Not Applicable

• Conditions: Stroke

• Registration Number: NCT04971603
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

Stroke and its sequelae are a major indication for acupuncture. The specific aims of this study are to assess the feasibility of pragmatic clinical trial on acupuncture in primary care setting and evaluate the effectiveness and safety of acupuncture for stroke rehabilitation in Hong Kong.

Detailed Description

The study will help to develop ap treatment patterns for stroke rehabilitation of elderly patients in Hong Kong. The specific aims of this study are to assess the feasibility of pragmatic clinical trial on acupuncture in primary care setting and evaluate the effectiveness and safety of acupuncture for stroke rehabilitation on motor, sensation, speech, swallowing, cognitive, and other neurological functions.

This study includs 2-week run-in, 24-week treatment, 12-week follow up and 9 visits at week 0, 2, 6, 10, 14, 18, 22, 26 and 38. The investigator will recruit totally 500 patients fulfiling the eligibility criteria in four neighbourhood elderly centres of The Hong Kong Sheng Kung Hui Welfare Council and Chinese medicine clinics of Hong Kong Baptist University. Acupuncture treatment will be applied to the patients and seven visits will be arranged within the 24-wk treatment period providing medical consultation and recording improvement and any adverse effect.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-01
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-21
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Participants who meet the following criteria will be included: (1) 35~90 years or older; (2) discharged from hospital; (3) diagnosed with cerebral hemorrhage or cerebral infarction through brain computed tomography (CT) or magnetic resonance imaging (MRI); (4) stable vital signs; and (5) voluntary participation with informed consents signed in this study.

Exclusion Criteria

• The following participants are excluded: (1) patients with unconsciousness, aphasia, and cognitive dysfunction (Mini-Mental State Examination-Korean version (MMSE-K) <24); (2) those with a past history of brain disease (e.g., mental illness, consciousness disorder due to head trauma, previous brain surgery, or spastic disease); (3) those with severe heart, liver, or kidney disease or bleeding disorders; (4) those with other serious diseases (e.g., cancer, dementia (Alzheimer's disease or dementia of Lewy body), Parkinson's disease, and Parkinson's syndrome); (5) those who participated in other clinical trials within last three months; (6) those with needle phobia; and (7) pregnant or lactating female patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Activities of daily living (ADL) scores	9 months	ADL is commonly utilized to indicate the patient's functioning condition and level of care assistance by the Hospital Authority in Hong Kong.

Secondary Outcome Measures

Name	Time	Method
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)	9 months	The TCMSSS is based on \<Criteria for diagnosis and curative effect evaluation of stroke\>. Total scores range from 0 to 52, with scores above 40 indicating very severe neurological impairment, scores of 14 to 39 suggesting moderately severe to severe impairment, and scores below 13 indicating mild impairment.
Constitution in Chinese Medicine Questionnaire (CCMQ)	9 months	The CCMQ is applied to evaluate body constitution of each patient by score (Balanced Constitution, Qi-deficient Constitution, Yang-deficient Constitution, Yin-deficient Constitution, Phlegm-dampness Constitution, Damp-heat Constitution, Stagnant Blood Constitution, Stagnant Qi Constitution, and Inherited Special Constitution).
Mini-mental state examination (MMSE)	9 months	The MMSE test is a standard tool for cognitive assessment in the clinical setting. It is a 10-minute bedside measure of impaired thinking in undeveloped, uneducated, diseased, or very old populations. The summed score of the individual items indicates the current severity of cognitive impairment.

Trial Locations

Locations (1)

Hong Kong; 🇭🇰 Kowloon Tong, Kowloon, Hong Kong