Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years, male or female; 2.Subjects with stroke diagnosed by CT and/or MRI and clinical diagnosis with one side hemiplegia; 3.First onset, stable vital signs, course of disease: 2 weeks to 3 months; 4.FAC functional walking ability scale >= level 1; 5.Clear mind, cooperate with physical examination, and can accept movement instructions; 6.Subjects or their guardians can understand the study purpose, demonstrate adequate compliance with the study protocol, and sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Brunnstrom stage of the affected lower limb > V; 2.Modified Ashworth Scale (hip, knee, ankle) of the affected side: any joint >= grade 3; 3.Severe heart disease, severe and uncontrollable hypertension, unstable angina attack, cardiac dysfunction grade III or above, acute myocardial infarction; 4.Local skin injury of lower limbs or local pressure ulcers; 5.A history of peripheral neuropathy; 6.A history of epilepsy, spinal cord injury, amputation, or severe lower limb joint disease; 7.Contraindication for the use of related products; 8.Major organ failure or other serious diseases (including malignant tumors; A history of severe mental illness; Active disseminated intravascular coagulation; Systemic metabolic diseases beyond control); 9.Female subjects with positive pregnancy test during pregnancy or lactation or screening; 10.Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment; 11.A history of drug abuse; 12.Known refusal or inability to comply with protocol requirements (including planned clinical visits and examinations) for any reason; 13.In the interest of the subjects, the investigator considers that they should not participate in other aspects of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cortical somatosensory evoked potentials and motor evoked potentials after treatment;After treatment, Fugl-meyer lower extremity motor function assessment scale score of lower extremity;Berg balance score after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Brunnstrom grading of the lower extremity;Holden walking function grading;Ashworth scale score for lower extremity improvement;Gait analysis test;Functional magnetic resonance imaging; | — |
Countries
China
Contacts
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology