Wolf I Care Abstract
The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) for Stroke Initiative (R01NS056256) has been funded by the National Instititute of Neurological Disease and Stroke (NINDS) of the National Institutes of Health, effective July 1, 2008. This 5-year $12.4 million grant will be headed by Carolee Winstein, Ph.D., PT, FAPTA at the University of Southern California, Department of Biokinesiology and Physical Therapy. Steven L. Wolf, Ph.D., PT, FAPTA (Department of Rehabilitation Medicine, Emory University School of Medicine) and Alex W. Dromerick, MD (National Rehabilitation Hospital and Georgetown School of Medicine) are co-Principal Investigators.
The primary objective of I-CARE is to improve outpatient therapy for arm paresis after stroke. This Phase III, single blind, multi-center, randomized control trial will 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 randomized clinical trial (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.
360 adults, within one to three months of stroke onset, with mild to moderate upper extremity impairment will be randomized. The 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, the ultimate goal for the ICARE Trial 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.