The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke

Hong Kong Baptist University

Status: Unknown

Conditions: Stroke

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04971603

Acupuncture for stroke

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 35 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

500 participants in 1 patient group

Acupuncture treatment group

Experimental group

Description:

The patients will receive 24-week acupuncture treatment and 12-week follow up. Seven visits will be arranged within the 24-wk treatment period and at the end of study at wk 6, 10, 14, 18, 22, 26 and 38 for medical consultation and investigation.

Treatment:

Other: Acupuncture