Clinical trial NCT03712085: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Ischemia
Hemiplegic Patients With Stroke
Image Science
Electrophysiology of Neuromuscular
Abdominal Acupuncture
Keywords: Functional magnetic resonance imaging（fMRI）
Surface electromyography （sEMG）
Abdominal acupuncture
Brain Plasticity
Effects and mechanism
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2018-10-19
Enrollment: 66
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The integrity of the corticospinal tract
timeFrame: Diffusion tensor imaging(DTI) will be tested before treatment and 4 weeks after treatment,twice totally.
measure: Motor function of muscles
timeFrame: SEMG will be tested before and after 4 weeks treatment,twice totally.
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
measure: Brunnstrom staging of upper limb movement
timeFrame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
measure: Fugl-Meyer Motor Assessment of upper limb
timeFrame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
measure: Modified Barthel Index，MBI
timeFrame: Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Traditional Chinese Medicine
state: Guangdong
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Director of the rehabilitation department
name: Hongxia Chen, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor
name: Vincet Chi-kwan Cheung, Doctor
role: PRINCIPAL_INVESTIGATOR
References: