Stroke
Conditions
Interventions
rPMS+RAS group:rPMS with RAS
RAS group:sham-rPMS with RAS
Control group:sham-rPMS with conventional occupational therapy
Sponsors
Jing'an District Central Hospital Of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The diagnosis conforms to the consensus of the "Key Points for the Diagnosis of Major Cerebrovascular Diseases in China 2019" formulated by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association, and is confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 2. The first onset of the disease, the age of the patient is 18 ~ 80 years old; 3. The condition is stable, no serious complications, and the course of the disease is 14 days ~ 6 months; 4. Presence of hemiplegia and hemiplegia sensory impairment (impairment of at least one of the sensory functions of superficial sensation, proprioception, and composite sensation at screening); 5. Upper extremity Brunnstrom on the affected side is staged in stages II.-V; 6. Mini-Mental Scale (MMSE) > 24 points, able to complete the assessment and training process; 7. The patient was treated conservatively after the onset of the disease, and did not receive surgical treatment such as craniotomy; 8. Patients voluntarily participate in this study and sign the informed consent form by themselves, and those who are unable to sign with hand motor dysfunction can sign the informed consent through handprints or video shooting as proof of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Visual impairment, hearing impairment, cognitive impairment or aphasia and other difficulties in cooperating with the completion of assessment and treatment; 2. Have a history of seizures, family history of epilepsy, or are taking anti-epileptic drugs prophylactically; 3. Serious primary diseases such as heart, lung, liver, kidney and hematopoietic system; 4. Metal foreign bodies in the body or other electronic devices implanted in the body, such as pacemakers, steel nails, etc.; 5. Moderate to severe spasm (modified Ashworth score >=2) of the wrist and hand of the affected limb or skin ulceration and infection around the irritating point; 6. Upper limb dysfunction on the affected side (upper limb fracture, severe arthritis, joint replacement, etc.) caused by other reasons before or in the near future; 7. Participate in other clinical trials during pregnancy, lactation, or at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer assessment upper extremity, FMA-UE;functional near-infrared spectroscopy, fNIRS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Action research arm test, ARAT;Manual muscle test, MMT ;Surface Electromyography, sEMG ;Box and Block test, BBT;Range of Motion, ROM;Grip strength;Semmes Weinstein Monofilaments Examination, SWME;Two-Point Discrimination Test,2PD;Erasmus MC revised Nottingham sensory assessment scale, Em-NAS;Digital Span Test, DST;Modified Barthel Index, MBI;Resting-State Functional Magnetic Resonance Imaging (fMRI) data;Diffusion Tensor Imaging; | — |
Countries
China
Contacts
Public ContactJia Jie
Shanghai Jing'an District Central Hospital(Jing 'an Branch of Huashan Hospital,Fudan University)
Outcome results
None listed