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

Guangzhou University of Traditional Chinese Medicine

Status: Unknown

Conditions: Hemiplegic Patients With Stroke; Brain Ischemia; Abdominal Acupuncture; Electrophysiology of Neuromuscular; Image Science

Treatments: Other: Abdominal acupuncture; Other: Sham abdominal acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03712085

YN2018HK03

Details and patient eligibility

About

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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66 participants in 3 patient groups

Treatment Group A

Active Comparator group

Description:

Abdominal acupuncture and upper limb rehabilitation training

Treatment:

Other: Abdominal acupuncture

Treatment Group B

Sham Comparator group

Description:

Sham abdominal acupuncture and upper limb rehabilitation training

Treatment:

Other: Sham abdominal acupuncture

Control Group

No Intervention group

Description:

Upper limb rehabilitation only