Stroke
Conditions
Interventions
Intelligent Closed-Loop Intervention Group:In addition to conventional rehabilitation therapy, participants will receive closed-loop neuromuscular electrical stimulation combined with upper limb robot
Conventional Electrical Stimulation Group:In addition to conventional rehabilitation therapy, participants will receive traditional functional electrical stimulation. Stimulation parameters will be pr
Sponsors
Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Meet the ischemic stroke criteria outlined in the "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2023", and confirmed by cranial CT or MRI examination; 2. First episode, unilateral hemiplegia; 3. The onset time ranges from 2 days to 12 months, with stable vital signs; 4. Age range: 35-90 years old; 5. Clinical manifestations include motor dysfunction of the upper limbs; 6. Able to maintain an independent sitting position for 1 hour or longer; 7. The patient's condition is stable, with clear consciousness, no aphasia or impairment, and the ability to understand the content of the scale and cooperate with examinations and treatments; 8. Have not taken any Chinese or Western sedatives or muscle relaxants within 2 weeks; 9. Obtain informed consent and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient is in a critical condition or the condition has not stabilized in the acute phase; 2. Individuals who have conditions such as deafness, aphasia, or severe cognitive impairment, making it difficult for them to communicate normally; 3. Sensory dysfunction of the affected limb; 4. Patients with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg, those with severe primary diseases in cardiovascular, liver, kidney, blood, digestive, respiratory, and other systems, psychiatric patients, patients with malignant tumors, venous thrombosis, osteoporosis, severe bleeding tendency, and infection at the treatment site; 5. Those who are unable to cooperate with the rehabilitation protocol of this study, or who have participated in other clinical trials within 3 months, or who have received other related treatments during the study, which may affect the efficacy evaluation of this study; 6. Dystonia caused by other reasons and previous motor dysfunction; 7. Pregnant and lactating women; 8. The patient has a history of trauma and osteoarticular diseases in the hemiplegic upper limb; 9. Severe spasticity, i.e., modified Ashworth scale score exceeding grade III; 10. Implantation of cardiac pacemakers, cochlear implants, and other medical devices in the body; 11. Previously underwent vagus nerve surgery; 12. Currently using or planning to use medications that may affect nervous system function, muscle response, or electrophysiological signals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Upper Extremity Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Barthel Index Score; | — |
Countries
China
Contacts
Public ContactCong Wang
Tongren Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed