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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01NS056256-03
Application #
7906637
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Cordell, Janice
Project Start
2008-08-01
Project End
2013-07-31
Budget Start
2010-08-01
Budget End
2011-07-31
Support Year
3
Fiscal Year
2010
Total Cost
$2,921,332
Indirect Cost
Name
University of Southern California
Department
Dentistry
Type
Schools of Dentistry
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Lewthwaite, Rebecca; Winstein, Carolee J; Lane, Christianne J et al. (2018) Accelerating Stroke Recovery: Body Structures and Functions, Activities, Participation, and Quality of Life Outcomes From a Large Rehabilitation Trial. Neurorehabil Neural Repair 32:150-165
Edwardson, Matthew A; Wang, Ximing; Liu, Brent et al. (2017) Stroke Lesions in a Large Upper Limb Rehabilitation Trial Cohort Rarely Match Lesions in Common Preclinical Models. Neurorehabil Neural Repair 31:509-520
Rowe, Veronica T; Winstein, Carolee J; Wolf, Steven L et al. (2017) Functional Test of the Hemiparetic Upper Extremity: A Rasch Analysis With Theoretical Implications. Arch Phys Med Rehabil 98:1977-1983
Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W et al. (2016) Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA 315:571-81
Kwakkel, Gert; Veerbeek, Janne M; van Wegen, Erwin E H et al. (2015) Constraint-induced movement therapy after stroke. Lancet Neurol 14:224-34
Duff, Susan V; He, Jiaxiu; Nelsen, Monica A et al. (2015) Interrater reliability of the Wolf Motor Function Test-Functional Ability Scale: why it matters. Neurorehabil Neural Repair 29:436-43
Wade, Eric; Chen, Christina; Winstein, Carolee J (2014) Spectral analyses of wrist motion in individuals poststroke: the development of a performance measure with promise for unsupervised settings. Neurorehabil Neural Repair 28:169-78
Winstein, Carolee; Lewthwaite, Rebecca; Blanton, Sarah R et al. (2014) Infusing motor learning research into neurorehabilitation practice: a historical perspective with case exemplar from the accelerated skill acquisition program. J Neurol Phys Ther 38:190-200
Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W et al. (2013) Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol. BMC Neurol 13:5
Wade, Eric; Dye, Jonathan; Mead, Ross et al. (2011) Assessing the quality and quantity of social interaction in a socially assistive robot-guided therapeutic setting. IEEE Int Conf Rehabil Robot 2011:5975358

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