Hemiplegia of the limbs after ischemic stroke
Conditions
Interventions
experimental group:VNS Joint Robot Synchronized Rehabilitation Training
Sponsors
Xi'an International Medical Center Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. History of unilateral supratentorial ischemic stroke with a disease duration of 6–60 months, currently stable. 2. Age 20–70 years. 3. Right or left limb weakness, with an FMA-UE motor function score of 20–50 points. 4. Ability to communicate, understand, and provide informed consent. 5. Patients who have provided informed consent before surgery, voluntarily signed the informed consent form, and have no contraindications for surgery.
Exclusion criteria
Exclusion criteria: 1. History of hemorrhagic stroke. 2. Persistent difficulty swallowing or inhaling. 3. Use of medications at the start of the study that may significantly interfere with the effects of VNS on the neurotransmitter system, such as central nervous system stimulants, vasoactive drugs, or cardiac stimulants, among others, with specific determination based on the specific medication. 4. Bilateral or unilateral vagus nerve damage. 5.Severe or more severe depression (Beck Depression Inventory >29). 6. Ineligible for device implantation surgery, with potential risk of rejection. 7 Currently using any other stimulation device, such as a pacemaker or other neural stimulator; currently using any other experimental device or medication. 8. Pregnancy, planning to become pregnant, or breastfeeding during the study period. 9. Requirement for thermal therapy during the study period. 10. Active rehabilitation within four weeks prior to informed consent. 11. Within four weeks after 90 days of active VNS therapy, participants will be offered botulinum toxin injection or other non-study-related active rehabilitation for the upper limb. 12. Severe spasticity of the upper or lower limb (modified Ashworth scale score >=3). 13. Severe sensory loss. Sensory loss will be measured using the limb sensation section of the Fugl-Meyer Physical Function Assessment. The assessment includes light touch (two items) and proprioception (four items). Participants with scores below 6 for the upper or lower limbs will be excluded. 14. Participants with severe systemic diseases, such as ALT > 2 times the upper limit of normal, Cr > 6 times the upper limit of normal, severe pulmonary insufficiency, asthma, or arrhythmia (especially bradycardia with a heart rate <= 55 beats per minute). 15. Participants with other intracranial organic diseases, such as intracranial infection, high-grade malignant tumors, or primary epilepsy. 16. Participants with neurological diseases, such as Parkinson's syndrome, Alzheimer's disease, or peripheral neuropathy. 17. Participants with psychiatric disorders, such as schizophrenia or severe depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FMA-UE score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional independence measure, FIM;Berg balance scale,BBS;Action Research arm test,ARAT;Motor Status Scale, MSS;Wolf Motor Function Test, WMFT;Lindmark balance test;Surface electromyography, sEMG;Optically pumped magnetometer magnetoencephalography, OPM-MEG; | — |
Countries
China
Contacts
Public ContactShiming He
Xi'an International Medical Center Hospital
Outcome results
None listed