Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke

Completed

Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

1. upper extremity Fugl Meyer score >10-< 25 (i.e., subject must score between (and including) 10 and 25 on the UE FM at the baseline screening appointment only)
2. presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
3. stroke experienced > 1 month prior to study enrollment
4. a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
5. age > 35 < 85
6. have experienced one stroke
7. discharged from all forms of physical rehabilitation
8. Myomo brace fits on affected arm properly and without discomfort (i.e., no red marks or discomfort observed in 10 minutes of use during fitting).
9. < 35 years old
10. excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale
11. excessive spasticity at the affected elbow, as defined as a score of > 4 on the Modified Ashworth Spasticity Scale
12. currently participating in any experimental rehabilitation or drug studies
13. apraxia (< 2.5 on the Alexander scale)
14. severe sensory loss in affected hand (Nottingham sensory scale at least 75% of normal)
15. severe language deficits (score < 2 on NIH Stroke Scale question 9)
16. Stroke that occurred in the brainstem (corticospinal tracts are the final pathway for the motor system, and are frequently damaged in brainstem strokes. These individuals are hypothesized to be less likely to benefit from the cortical plasticity seen with exercise therapy, and are therefore excluded from this study.)
17. A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment (Subjects must be able to tolerate a one-hour upper-extremity therapy session.)
18. History of neurological disorder other than stroke (other neurological disorders may affect the upper extremity motor performance of subjects.); (11) Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace (While wearing the brace, the system is pressed close to the upper arm and strapped around it. (If the subject suffers from dermal breakdown or other skin conditions that may be aggravated by such a situation, they should not be involved in the study.)
19. Substantial contracture of elbow, defined as > 20 degrees of elbow flexion, as measured at the baseline evaluation. (The system cannot work in the presence of reduced range of motion due to contractures.).