Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke


Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Upper extremity Fugl Meyer score >10-< 25
- presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
- stroke experienced > 1 month prior to study enrollment;
- a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
- age > 35 < 85
- have experienced one stroke
- discharged from all forms of physical rehabilitation
- 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).

Exclusion Criteria

- < 35 years old
- excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale
- excessive spasticity at the affected elbow, as defined as a score of > 4 on the Modified Ashworth Spasticity Scale
- currently participating in any experimental rehabilitation or drug studies
- apraxia (< 2.5 on the Alexander scale)
- severe sensory loss in affected hand (Nottingham sensory scale at least 75% of normal)
- severe language deficits (score < 2 on NIH Stroke Scale question 9)
- Stroke that occurred in the brainstem
- A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
- History of neurological disorder other than stroke (other neurological disorders may affect the upper extremity motor performance of subjects.)
- Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace
- Substantial contracture of elbow, defined as > 20 degrees of elbow flexion, as measured at the baseline evaluation.