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
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Acupuncture||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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)|
|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|
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.
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).
- 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.
- 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.
- 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.
- 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).
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
|Contact: Linda Zhong, MD.,PH.Demail@example.com|
|Contact: Zhaoxiang Bian, MD.,PH.D|
|Kowloon Tong, Kowloon, Hong Kong|
|Contact: Linda Zhong, MD,PhD 34116523 firstname.lastname@example.org|