Comparing a novel neuroanimation experience to conventional therapy for high-dose, intensive upper-limb training in subacute stroke: The SMARTS2 randomized trial

BackgroundEvidence from animal studies suggests that greater reductions in post-stroke motor impairment can be attained with significantly higher doses and intensities of therapy focused on movement quality. These studies also indicate a dose-timing interaction, with more pronounced effects if high-intensity therapy is delivered in the acute/subacute, rather than chronic, post-stroke period. ObjectiveTo compare two approaches of delivering high-intensity, high-dose upper limb therapy in patients with subacute stroke: a novel exploratory neuro-animation therapy (NAT), and modified conventional occupational therapy (COT). MethodsTwenty-four patients were randomized to NAT or COT and underwent 30 sessions of 60 minutes time-on-task in addition to standard care. The primary outcome was the Fugl-Meyer Upper Extremity motor score (FM-UE). Secondary outcomes included: Action Research Arm Test (ARAT), grip strength, Stroke Impact Scale (SIS) hand domain, and upper-limb kinematics. Outcomes were assessed at baseline, and days 3, 90, and 180 post-training. Both groups were compared to a matched historical cohort (HC), which received only 30 minutes of upper limb therapy per day. ResultsThere were no significant between-group differences in FM-UE change or any of the secondary outcomes at any timepoint. Both high-dose groups showed greater recovery on the ARAT (7.3 {+/-}2.9 pts, p=0.011), but not the FM-UE (1.4 {+/-}2.6 pts, p =0.564) when compared to the HC. ConclusionsTwo forms of high-dose intensive upper limb therapy produced greater activity but not impairment improvements compared with regular care. Neuroanimation may offer a new enjoyable, efficient and scalable way to deliver increased upper limb therapy. Clinicaltrials.gov registration NCT02292251