Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) spastic hemiplegia caused by stroke (including hemorrhagic and ischemic), including but not limited to those with difficulty in opening hands; (2) the total score of Fugl Meyer's upper extremity movement scale 15 to 35; (3) aged 40 to 70 years; (4) after stroke onset, it is more than or equal to 1 year. After stroke onset, the patients have received regular rehabilitation treatment in hospital for at least 6 months, and the recovery of upper limb function has entered the platform stage. In recent 3 months, no intensive rehabilitation treatment for upper limb has been carried out in the hospital, that is, if the upper limb rehabilitation treatment has been carried out in the hospital in recent 3 months, the average treatment time should be less than 1 hour per week; (5) MRI confirmed that the damage of central nervous system only involved one side of cerebral hemisphere; (6) patient and his/her family members have the intention to improve the function of the affected upper limb, and have the intention to do the left and right seven neck cross displacement, and there is no surgical contraindication; (7) consciousness, intelligence and language, be able to fully understand and follow the doctor's treatment instructions, and sign the informed consent. All the above conditions shall be met, and the first, second and fifth points shall be diagnosed by two specialists or above.
Exclusion criteria
Exclusion criteria: (1) any subject with recurrent acute cerebral infarction or cerebral hemorrhage; (2) subjects with metal retention in the head after cranioplasty; (3) subjects with stiff joints; (4) serious fixation contracture or joint deformity; (5) mental and language disorders, MMSE score less than 27; (6) the life expectancy of subjects is less than 15 months; (7) those who have participated in clinical trials of other drugs or medical devices before being selected but failed to reach the time limit of main research end point; (8) the researcher judged that the subjects' compliance was poor and could not complete the clinical trial as required; (9) patient and his/her family members refused to participate in the clinical trial; (10) Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in total score of fugl-meyer scale; | — |
Countries
China
Contacts
Huashan Hospital, Fudan University