The Clinical Efficacy and Neural Correlates on Acupuncture for Lower Extremity Motor Rehabilitation of Post Ischemic Stroke: A Three-Armed Multi-Central Randomized Controlled Trial

Phase 1

Recruiting

Conditions: Ischemic stroke
8B11.3

Registration Number: ITMCTR2000003923

Lead Sponsor: First Teaching Hospital of The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of ischemic stroke, and it is the first attack;
2. Patients with stable vital signs 2-14 days after stroke onset (GCS score > 8);
3. Basal ganglia (internal capsule) and (or) corona radiata infarction (diameter > 1.5cm), accompanied by lower extremity motor dysfunction (muscle strength <= 3), can be combined with upper limb motor dysfunction (NIHSS score 3-15);
4. Patients aged 40-70 years;
5. Right handed patients;
6. Patients who have informed consent and signed informed consent.

Exclusion Criteria

1. The subjects who had been dependent on daily activities before the stroke;
2. Stroke patients who have received thrombolysis or thrombectomy treatment;
3. Infection of acupuncture site and (or) objects unable to tolerate acupuncture treatment;
4. Patients with other serious concomitant diseases (aphasia, moderate to severe edema of lower limbs, venous thrombosis of lower limbs, arteriosclerosis occlusion of lower limbs, diabetic lower extremity vascular disease, peripheral neuropathy, myelopathy, brain trauma, intracranial infection, brain tumor, etc.), secondary diseases (such as heart, liver, renal failure, etc.);
5. Patients with contraindications to MRI (claustrophobia, surgical implantation of metal devices, etc.);
6. Subjects with MMSE score: illiterate < 17, primary school < 20, middle school and above < 24; Hamilton Depression Scale (HAMD-17) score > 17; Hamilton Anxiety Scale (HAMA) score >= 14.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
multimodal MRI;Fugl-Meyer Assessment (FMA);

Secondary Outcome Measures

Name	Time	Method
ational Institutes of Health Stroke Scale (NIHSS);Manual Muscle Testing (MMT);Efficacy Evaluation of Stroke of TCM;Stroke Impact Scale (SIS-16);Modified Barthel Index (MBI);Modified Ashworth Scale (MAS);