Using fMRI and sEMG to Evaluate the Effects and Mechanism on Abdominal Acupuncture Combined With Upper Limb Rehabilitation Training on Brain Plasticity of Hemiplegic Patients With Stroke
1 other identifier
interventional
66
2 countries
2
Brief Summary
Using random number method to categorize the selected first onset patients with stroke who meet the inclusion criteria into 3 groups.The patients were randomly divided into treatment group A(abdominal acupuncture+upper limb rehabilitation training, 22 cases), treatment group B(Sham abdominal acupuncture+upper limb rehabilitation training, 22 cases),and control group(upper limb rehabilitation training, 22 cases). SEMG and fMRI examination and related stroke rehabilitation assessment scales were evaluated before and after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 9, 2019
July 1, 2019
2 years
July 7, 2018
July 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The integrity of the corticospinal tract
The integrity of the corticospinal tract will be tested by diffusion trnsor imaging(DTI) of craniocerebral functional magnetic resonance imaging examination using magetic angiography to measure the changes caused by neuronal activity.We will observe the shape and integrity of the corticospinal tract.
Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
Motor function of muscles
Common measures of sEMG will be tested. See the study protocol for details.
SEMG will be tested before and after 4 weeks treatment,twice totally.
Secondary Outcomes (4)
Wolf Motor Function Test
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Brunnstrom staging of upper limb movement
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Fugl-Meyer Motor Assessment of upper limb
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Modified Barthel Index，MBI
Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Study Arms (3)
Treatment Group A
ACTIVE COMPARATORAbdominal acupuncture and upper limb rehabilitation training
Treatment Group B
SHAM COMPARATORSham abdominal acupuncture and upper limb rehabilitation training
Control Group
NO INTERVENTIONUpper limb rehabilitation only
Interventions
Abdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks.
Sham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min.
Eligibility Criteria
You may qualify if:
- First onset stroke, Left hemiplegia, Right-handed，and diagnosed by brain CT or MRI;
- Age 35 to 75 years old;
- Course of disease 0.5 to 3 months with stable vital signs;
- No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ;
- Can control the sitting balance. Brunnstrom stage of hemiplegic upper limb and hand is Ⅳ or V ，Fugl-Meyer Motor Assessment score of upper limb 20-50 point;
- Agree to sign the informed consent;
- Unilateral neglect.
You may not qualify if:
- Recurrent stroke，subarachnoid hemorrhage, brain tumors patients;
- Contraindication to undergo a 3T MR imaging;
- Claustrophobia;
- Have severe heart, hepatic or renal failure;
- Don' t cooperate with the treatment;
- Have participated in other clinical trails recently.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510120, China
The Chinese University of Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hongxia Chen, Master
Director of the rehabilitation department
- PRINCIPAL INVESTIGATOR
Vincet Chi-kwan Cheung, Doctor
Assistant professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2018
First Posted
October 19, 2018
Study Start
January 15, 2019
Primary Completion
January 1, 2021
Study Completion
December 1, 2021
Last Updated
July 9, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share