Residual disability after stroke is substantial, with about 65% of patients at 6 months unable to incorporate theparetic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reducedquality of life after stroke. The primary objective of I-CARE (Interdisciplinary Comprehensive Arm RehabilitationEvaluation) is to improve outpatient therapy for arm paresis after stroke. We will conduct a Phase III, singleblind,multi-center, randomized control trial to investigate the effectiveness of ASAP (Accelerated SkillAcquisition Program), a focused, intense, evidence-based, upper extremity rehabilitation program. ASAPcombines aspects of constraint-induced therapy, skill-based/impairment-mitigating task-specific training withembedded motivational enhancements and includes 30 hours of one-on-one therapy initiated during the earlypost-acute outpatient interval (1-3 months) after stroke.This RCT has one primary aim: Compare ASAP to a dose equivalent usual and customary occupationaltherapy (high dose) group. There are two secondary aims: a) Compare ASAP to a true (monitoring only) usualand customary therapy group (low dose) and b) Compare the high dose usual and customary occupationaltherapy group to the low dose usual and customary occupational therapy group.We will randomize 360 adults, within one to three months of stroke onset, with mild to moderate upperextremity impairment. Our primary outcome is a performance-based arm function test, Wolf Motor FunctionTest (WMFT) at one year after participation. Secondary outcomes include patients self-perception of paretichand function, a domain of the Stroke Impact Scale (SIS) and the full SIS. Specific subgroup analyses willexplore important moderating factors including duration from onset, stroke type, and motor impairment.Given the trend toward diminished total reimbursable time for stroke rehabilitation, our ultimate goal is toprovide evidence toward an optimal allocation of therapy services within the approved number of treatmentsessions that will reduce disability, lessen the societal burden, and provide a standardized evidence-basedtreatment useful for the rehabilitation clinician and future clinical trialist.
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