Stroke remains a leading and increasingly common source of disability, causing devastating upper extremity (UE) impairments. Because UE use is critical to motor return, many contemporary rehabilitative approaches emphasize repetitive, task-specific, UE practice (RTP). However, most contemporary therapies are only efficacious in minimally-impaired patients who exhibit active distal UE movement: only a minority of the rapidly expanding survivor population. Concurrently, there remains a relative paucity of efficacious UE treatments that incorporate RTP for stroke survivors exhibiting moderate to severe UE impairment levels. The PI was the first to show increased UE use and function by delivering RTP augmented by concurrent electrical stimulation to chronic, moderately-impaired survivors. This integrated regimen uses an innovative electrical stimulation neuroprosthesis (ESN), and was validated in small pilot studies, followed by studies determining the regimen's biomarkers, and optimal duration, all in chronic stroke. This approach uniquely integrates evidence-based behavioral techniques to address physical deficits and mitigate common UE compensatory strategies (e.g., learned disuse) exhibited by subacute stroke survivors. This regimen could reduce UE impairment in hundreds of thousands annually if validated subacutely. In preparation for a larger trial, the primary study objective is to collect randomized, controlled, data estimating the RTP+ESN subacute treatment effect, which is necessary to design a definitive trial. The authors will randomize 40 subacute stroke patients with UE hemiparesis to participate in standardized regimens of: (a) RTP only (RTP), since motor learning-based RTP is the most frequently-used subacute UE strategy; or (b) RTP augmented by ESN (RTP + ESN). Outcomes span the international classification of function and include UE impairment, functional limitation, gross dexterity, UE use in laboratory and community activities, participation, and kinematics using a protocol validated by this laboratory. Supported by nearly a decade of preliminary experiences, the central hypothesis is that RTP+ESN will significantly reduce UE impairment. The research team will test the central hypothesis and accomplish the study objective by pursuing the following specific aims: (1) Determine the impact of RTP+ESN on subacute UE outcomes; and (2) Determine clinically important differences (CIDs) in moderately impaired stroke.
|Effective start/end date||07/01/2015 → 06/30/2017|