Stroke
Conditions
Interventions
Group 1:group of force feedback robot training
Group 2:group of task-oriented training
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The first onset of stroke and in line with the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2014" issued in 2015, confirmed by head CT or MRI imaging scan; 2) The course of disease >= 3 months and <= 12 months; 3) The condition is stable after brain injury; 4) Aged 18-80 years old; 5) Upper limb motor dysfunction; 6) Brunnstrom upper limb stage 2-5, Fugl-meyer < 56 points; 7) Clear consciousness, good cardiopulmonary function, stable vital signs, can be a good cooperation with the training; 8) Commit to abide by the study procedures, and cooperate with the implementation of the whole process of research and sign the informed consent form; 9) Women of reproductive age, should be at least one month before screening, and commit to take contraception throughout the study period and continue until the specified time after the end of the study; 10) Men of reproductive age, Condom or other contraceptive methods should be used to ensure effective contraception by the spouse; 11) Commitment to comply with the precautions related to lifestyle during the study; 12) Willing to sign the informed consent form for this study.
Exclusion criteria
Exclusion criteria: 1) Accompanied by disturbance of consciousness or cognitive dysfunction [Mini- Mental State Examination (MMSE) = III; 3) Suffering from severe hypertension (systolic blood pressure > 200 mmHg, diastolic blood pressure > 110 mmHg), poor control of diabetes or Combined with liver, kidney, heart and other important organ dysfunction and other major diseases; 4) Shoulder with severe pain; 5) Severe shoulder, elbow passive joint range of motion is limited; 6) Refractory or multiple epilepsy; 7) A past history of severe upper and lower limb joint disease; 8) Built-in cardiac pacemakers or other metal medical devices; 9) Unstable fractures, severe osteoporosis; 10) Severe pre-stroke disability,(modified Rankin Scale, mRS = 5); 11) Severe impairment of vision, hearing or comprehension; 12) Pregnant or lactating women; 13) Known allergy, hypersensitivity or intolerance to intelligent force feedback robots; 14) Participating in another clinical trial; 15) Any condition that, in the opinion of the investigator, may impair the subject or cause the subject to be unable to meet or perform the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer upper limb rating scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wolf Motor Function Test;Upper limb modified Ashworth score;Modified Barthel Index;Objective indexes of intelligent force feedback robot evaluation system, including constant assistance, simulated assistance, simulated resistance and movement speed; | — |
Countries
China
Contacts
Public ContactQing Xie
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed