Back to resultsThe Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Chinese Medicine, Acupuncture
Eligibility 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.
Sites / Locations
- Hong KongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture treatment group
Arm 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.
Outcomes
Primary Outcome Measures
Activities of daily living (ADL) scores
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
Mini-mental state examination (MMSE)
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)
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)
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).
Full Information
NCT ID
NCT04971603
First Posted
July 11, 2021
Last Updated
July 11, 2021
Sponsor
Hong Kong Baptist University
1. Study Identification
Unique Protocol Identification Number
NCT04971603
Brief Title
The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke
Official Title
The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke: a Pragmatic Study of Acupuncture for Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hong Kong Baptist University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Chinese Medicine, Acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture treatment group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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 Measure Information:
Title
Activities of daily living (ADL) scores
Description
ADL is commonly utilized to indicate the patient's functioning condition and level of care assistance by the Hospital Authority in Hong Kong.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Mini-mental state examination (MMSE)
Description
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.
Time Frame
9 months
Title
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Description
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.
Time Frame
9 months
Title
Constitution in Chinese Medicine Questionnaire (CCMQ)
Description
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).
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Zhong, MD.,PH.D
Phone
852-34116523
Email
ldzhong0305@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoxiang Bian, MD.,PH.D
Facility Information:
Facility Name
Hong Kong
City
Kowloon Tong
State/Province
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Zhong, MD,PhD
Phone
34116523
Email
ldzhong0305@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effectiveness and Safety of Acupuncture for Elderly Patients of Stroke
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