Post-Stroke Spastic Hemiplegia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meeting diagnostic criteria for stroke confirmed by cranial CT or MRI; (2) First-ever stroke or recurrent stroke without residual neurological deficits; (3) Disease course: 2 weeks to 6 months post-onset; (4) Age 35-75 years any gender; (5) Presence of hemiplegia or monoplegia with increased muscle tone Modified Ashworth Scale (MAS) grade 1-3; (6) Neurological deficit severity: NIHSS score 4-16; (7) Conscious (GCS score=15) clinically stable and capable of cooperating with interviews physical examinations instructions and treatment; (8) Voluntary participation with signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Severe primary diseases of cardiovascular hepatic renal immune or hematopoietic systems; infectious diseases malignancies or psychiatric disorders; coagulation dysfunction; (2) Secondary epilepsy or history of craniocerebral/spinal trauma or surgery; (3) Motor dysfunction (e.g. rheumatoid arthritis fractures trauma) that may interfere with efficacy evaluation; (4) Use of muscle relaxants within 1 month or receipt of acupuncture therapy within 3 months; (5) Skin lesions inflammation or scars at acupoints; allergy to trial materials (alcohol acupuncture needles) or severe allergic predisposition; (6) Positive pregnancy test current pregnancy/lactation or pregnancy planning within trial period; (7) Participation in other acupuncture/drug clinical trials within 3 months prior to screening or current enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified Ashworth Scale (MAS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Elasticity Modulus (Emax) in shear wave elastography;National Institutes of Health Stroke Scale (NIHSS);Clinical Spasticity Index (CSI);Fugl-Meyer Assessment (FMA) ;Surface Electromyography (sEMG);Barthel Index (BI); | — |
Countries
China
Contacts
Dongzhimen Hospital Beijing University of Chinese Medicine