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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038142
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Ischemic stroke

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

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

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; Hamilton Anxiety Scale (HAMA) score >= 14.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment (FMA);multimodal MRI;

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS);Modified Ashworth Scale (MAS);Manual Muscle Testing (MMT);Modified Barthel Index (MBI);Stroke Impact Scale (SIS-16);Efficacy Evaluation of Stroke of TCM;

Countries

China

Contacts

Public ContactChunhong Zhang

The First Affiliated Hospital of Tianjin University of traditional Chinese Medicine

drzch1113@tjutcm.edu.cn+86 13821537799

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026