Stroke (cerebral infarction or cerebral hemorrhage )
Conditions
Interventions
Randomly assign eligible patients to robotic therapy first group or control therapy first group.
Sponsors
Matsumoto Syuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who are able to give written consent in person. If the research subject has sufficient capacity to give consent but has difficulty in writing due to disability or other reasons, consent will be obtained by substitute writing after confirming that the subject himself/herself has consented toparticipate in the research. 2. Patients who are between 20 and 80 years of age at the time of consent. 3. Patients in the recovery phase of stroke (within6 months [180 days] of stroke onset). 4. Patients with first-ever stroke, stroke type of cerebral infarction or cerebral hemorrhage (subarachnoid hemorrhage is not eligible), and lesion site ofsupratentorial lesion. 5. Patients who are hospitalized for rehabilitation treatment after stroke. 6. Patients with hand BRS stage I to V on Brunnstrom Recovery Stage (BRS). 7. Patients with stable general condition such as blood pressure, pulse rate, and blood glucose.
Exclusion criteria
Exclusion criteria: 1. Patients with dyspnea on exertion, heart failure,arrhythmia, myocardial infarction, etc., for whom upper limb functional training is considered difficult. 2. Patients with a history of neurological disease or upper extremity joint disease that affects upper extremity function. 3. Patients with severe complications such as osteoarthritis of the shoulder and elbow, poorly controlled rheumatoid arthritis, scoliosis, osteoporosis, etc., who have difficulty in upper limb functional training or whose symptoms are judged to worsen with upper limb training. 4. Patients with serious hepatic disorder, renal disorder, or cardiovascular disease. 5. Patients with higher brain dysfunction such as severe sensory impairment, ataxia, and aphasia. 6. Examples of contraindications to upper limbrobotic training. 7. Patients who cannot apply the electrode pad due to skin diseases. 8. Patients who have changed the daily dose of any of the following drugs within the past month from the time of obtaining consent. - Antispasmodics (tizanidine hydrochloride, eperisone hydrochloride, baclofen, etc.) 9. Patients who, at the time of consent, required other medical treatment that would affect the study due to fracture, trauma, or other disease. 10. Patients who have received botulinum toxin injection or nerve block with phenol within the past 6 months from the time of consent. 11. Patients who have undergone robotic upper limb therapy within the past month from the time of consent. 12. Patients deemed by the physician to be unfit for upper extremity robotic use. 13. Patients who are participating in clinical trials or other clinical research involving interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences in total scores measured at 0 and 4, 8 weeks on the Fugl-Meyer Assessment (FMA)and Functional Independence Measure (FIM) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Motor Activity Log (MAL) 2) Active Range of Motion (A-ROM) 3) modified Ashworth scale (MAS) 4) grip (of hand) 5) Electromyogram evaluation 6) Simple Test for Evaluating hand Function (STEF) 7) Nine hole peg 8) Questionnaire (satisfaction with use of equipment, desire to use again, QOL score) 9) Adverse event assessment | — |
Contacts
Public ContactSyuji Matsumoto
Shin-Yachiyo Hospital
Outcome results
None listed