The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Can Acupuncture Benefit Surgical Patients With Haemorrhagic Stroke?

NCT01037894

Stroke

COMPLETED PHASE1/PHASE2

Acupuncture Treatment on Motor Dysfunction in Stroke Patients

NCT02975362

Stroke Motor Disorders

UNKNOWN NA

Acupuncture Therapy for Post-stroke Mild Cognitive Impairment: a Randomized Controlled Trial

NCT05924308

Post-stroke Mild Cognitive Impairment

UNKNOWN NA

Electroacupuncture Treatment for Post-stroke Cognitive Impairment

NCT07208019

Post-Stroke Cognitive Impairment (PSCI)

RECRUITING NA

Acupuncture for Post-stroke Shoulder-hand Syndrome

NCT02011854

Shoulder-hand Syndrome

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single arm prospective study. A total of 500 eligible patients will be recruited for 24-week treatment and 12-week follow up.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture treatment group

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

All acupuncture operations were done by registered Chinese medicine practitioner. Sterile, disposable acupuncture needles (0.25mmin diameter and 40mmin length) were used, which were purchased from HuaTuo acupuncture instrument.

Principal points: Neiguan (PC 6) \*, Sanyinjia (SP 6) \*, Weizhong (BL 40) \*, Baihui (GV 20), Shuigou (GV 26) \*, Zusanli (ST 36) \*, Quchi (LI 11) \*, Waiguan (TE 5) \*, Hegu (LI 4) \*, Huantiao (GB 30) \*, Yanglingquan (GB 34)\* (Grading of recommendation: C, level of evidence: IV).

Supplementary points: If upper limbs hemiplegia occurs, add Jianliao (TE 14) and Shousanli (LI 10); if lower limbs hemiplegia occurs, add Xuanzhong (GB 39) and Taichong (LR 3); if a deviation of the mouth or tongue occurs, add Dicang (ST 4) and Jiache (ST 6).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture

All acupuncture operations were done by registered Chinese medicine practitioner. Sterile, disposable acupuncture needles (0.25mmin diameter and 40mmin length) were used, which were purchased from HuaTuo acupuncture instrument.

Principal points: Neiguan (PC 6) \*, Sanyinjia (SP 6) \*, Weizhong (BL 40) \*, Baihui (GV 20), Shuigou (GV 26) \*, Zusanli (ST 36) \*, Quchi (LI 11) \*, Waiguan (TE 5) \*, Hegu (LI 4) \*, Huantiao (GB 30) \*, Yanglingquan (GB 34)\* (Grading of recommendation: C, level of evidence: IV).

Supplementary points: If upper limbs hemiplegia occurs, add Jianliao (TE 14) and Shousanli (LI 10); if lower limbs hemiplegia occurs, add Xuanzhong (GB 39) and Taichong (LR 3); if a deviation of the mouth or tongue occurs, add Dicang (ST 4) and Jiache (ST 6).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No