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The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke

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ClinicalTrials.gov Identifier: NCT04971603
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Other: Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke: a Pragmatic Study of Acupuncture for Primary Care
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: 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.
Other: 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).





Primary Outcome Measures :
  1. Activities of daily living (ADL) scores [ Time Frame: 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 :
  1. Mini-mental state examination (MMSE) [ Time Frame: 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.

  2. Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) [ Time Frame: 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.

  3. Constitution in Chinese Medicine Questionnaire (CCMQ) [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971603


Contacts
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Contact: Linda Zhong, MD.,PH.D 852-34116523 ldzhong0305@gmail.com
Contact: Zhaoxiang Bian, MD.,PH.D

Locations
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Hong Kong
Hong Kong Recruiting
Kowloon Tong, Kowloon, Hong Kong
Contact: Linda Zhong, MD,PhD    34116523    ldzhong0305@gmail.com   
Sponsors and Collaborators
Hong Kong Baptist University
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Responsible Party: Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT04971603    
Other Study ID Numbers: Acupuncture for stroke
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Kong Baptist University:
Stroke
Chinese Medicine
Acupuncture
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases