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

Not Applicable

• Conditions: Brain Ischemia; Abdominal Acupuncture; Electrophysiology of Neuromuscular; Image Science; Hemiplegic Patients With Stroke
• Interventions: Other: Abdominal acupuncture; Other: Sham abdominal acupuncture

• Registration Number: NCT03712085
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-19
• Study Start: 2019-01-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-07
• Last Update Posted: 2019-07-09
• Primary Completion: 2021-01
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment Group A	Abdominal acupuncture	Abdominal acupuncture and upper limb rehabilitation training
Treatment Group B	Sham abdominal acupuncture	Sham abdominal acupuncture and upper limb rehabilitation training

Primary Outcome Measures

Name	Time	Method
Motor function of muscles	SEMG 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 tract	Diffusion 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 Outcome Measures

Name	Time	Method
Modified Barthel Index，MBI	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.	See the study protocol for details
Wolf Motor Function Test	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.	See the study protocol for details
Brunnstrom staging of upper limb movement	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.	See the study protocol for details
Fugl-Meyer Motor Assessment of upper limb	Before treatment, 2 weeks and 4 weeks after treatment， 3 times totally.	See the study protocol for details

Trial Locations

Locations (2)

Guangdong Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong