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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03712085
Enrollment
66
Registered
2018-10-19
Start date
2019-01-15
Completion date
2021-12-31
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Acupuncture, Brain Ischemia, Electrophysiology of Neuromuscular, Hemiplegic Patients With Stroke, Image Science

Keywords

Functional magnetic resonance imaging(fMRI), Surface electromyography (sEMG), Abdominal acupuncture, Brain Plasticity, Effects and mechanism

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.

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.

OTHERSham abdominal acupuncture

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.

Sponsors

Chinese University of Hong Kong
CollaboratorOTHER
Guangzhou University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. First onset stroke, Left hemiplegia, Right-handed,and diagnosed by brain CT or MRI; 2. Age 35 to 75 years old; 3. Course of disease 0.5 to 3 months with stable vital signs; 4. No cognitive impairment. Can understand and execute commands. MMSE score more than 7 points. ; 5. 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; 6. Agree to sign the informed consent; 7. Unilateral neglect.

Exclusion criteria

1. Recurrent stroke,subarachnoid hemorrhage, brain tumors patients; 2. Contraindication to undergo a 3T MR imaging; 3. Claustrophobia; 4. Have severe heart, hepatic or renal failure; 5. Don' t cooperate with the treatment; 6. Have participated in other clinical trails recently.

Design outcomes

Primary

MeasureTime frameDescription
Motor function of musclesSEMG will be tested before and after 4 weeks treatment,twice totally.Common measures of sEMG will be tested. See the study protocol for details.
The integrity of the corticospinal tractDiffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.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.

Secondary

MeasureTime frameDescription
Wolf Motor Function TestBefore treatment, 2 weeks and 4 weeks after treatment, 3 times totally.See the study protocol for details
Brunnstrom staging of upper limb movementBefore treatment, 2 weeks and 4 weeks after treatment, 3 times totally.See the study protocol for details
Fugl-Meyer Motor Assessment of upper limbBefore treatment, 2 weeks and 4 weeks after treatment, 3 times totally.See the study protocol for details
Modified Barthel Index,MBIBefore treatment, 2 weeks and 4 weeks after treatment, 3 times totally.See the study protocol for details

Countries

China, Hong Kong

Contacts

Primary ContactHongxia Chen, Master
chx2004@126.com020-39318381
Backup ContactRuihuan Pan, Doctor
panruihuan@163.com020-39318381

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026