Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke
Hemiparesis
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring RTP Only Group, Myomo Only Group, Myomo + RTP Group
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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).
- < 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 (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.)
- 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.)
- 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.)
- 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.).
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Experimental: Myomo Only Group
Experimental: Myomo + RTP Group
Active Comparator: RTP Group
Experimental: Myomo Only Group Patients are administered rehabilitative therapy known as "repetitive task specific practice" (RTP) using only the Myomo robotic device targeting their affected arms on 3 days/week, in 1/2 hour increments, during an 8-week period.
Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week in 1/2 hour increments, during an 8 week period. These patients engage in activities that emphasize use of their affected arms repetitively, with the device providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the device during the activities is reduced.
Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. In this condition, patients engage in activities that emphasize use of their affected arms repetitively, with the therapist providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the therapist during the activities is reduced.