Residual disability after stroke is substantial, with about 65% of patients at 6 months unable to incorporate the paretic hand effectively into daily activities. In turn, this degree of functional deficit contributes to a reduced quality of life after stroke. The primary objective of I-CARE (Interdisciplinary Comprehensive Arm Rehabilitation Evaluation) is to improve outpatient therapy for arm paresis after stroke. We will conduct a Phase III, single- blind, multi-center, randomized control trial to investigate the effectiveness of ASAP (Accelerated Skill Acquisition Program), a focused, intense, evidence-based, upper extremity rehabilitation program. ASAP combines aspects of constraint-induced therapy, skill-based/impairment-mitigating task-specific training with embedded motivational enhancements and includes 30 hours of one-on-one therapy initiated during the early post-acute outpatient interval (1-3 months) after stroke. This RCT has one primary aim: Compare ASAP to a dose equivalent usual and customary occupational therapy (high dose) group. There are two secondary aims: a) Compare ASAP to a true (monitoring only) usual and customary therapy group (low dose) and b) Compare the high dose usual and customary occupational therapy 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 upper extremity impairment. Our primary outcome is a performance-based arm function test, Wolf Motor Function Test (WMFT) at one year after participation. Secondary outcomes include patients'self-perception of paretic hand function, a domain of the Stroke Impact Scale (SIS) and the full SIS. Specific subgroup analyses will explore 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 to provide evidence toward an optimal allocation of therapy services within the approved number of treatment sessions that will reduce disability, lessen the societal burden, and provide a standardized evidence-based treatment useful for the rehabilitation clinician and future clinical trialist. Project Narrative: The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (I-CARE) Stroke Initiative trial implements the 2006 Report of the NINDS Stroke Progress Review Group's established priorities for stroke recovery and rehabilitation research. I-CARE is an RCT that will test ?important parameters of conventional rehabilitation interventions including: timing, dosing schedule, half life of treatment effect, and (the) differential effects of various training paradigms?. If our primary hypothesis is supported, this Phase III trial would change current neurorehabilitation treatment during post-acute outpatient therapy for those with mild to moderate arm and hand impairments. Our secondary hypothesis is equally important: comparing a high therapy dose to the lower dose usually provided will determine if dose alone impacts functional outcomes. The findings of I-CARE will establish evidence-based recommendations for the content of outpatient arm therapy and the number of visits necessary to optimize outcome. Further, I-CARE will generate two standardized outpatient neurorehabilitation protocols that can be used in trials of current and future experimental interventions such as pharmacological agents, gene therapy, stem cell implants, and direct cortical stimulation.
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