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Author Notes:
CJW in collaboration with SLW and AWD led the conceptualization, design, and implementation of this research protocol. CJW is one of two founding developers of the ASAP principles and protocol being tested in this trial. She chairs the executive committee and is the primary author for this manuscript. SLW is responsible for managing his subcontract and providing leadership to his Center including all clinical affiliates. He provides guidance to the work of the WMFT FAS review panel and BE committee with respect to the WMFT. He is a contributing author and provided critical review of the manuscript. AWD is the study Medical Director for ICARE. He is responsible for all medical and neurologic issues that arise during participant screening, therapy, and follow-up. He chairs the Physician Investigator Committee. He is responsible for managing his subcontract and providing leadership to his Center including all clinical affiliates. He is a contributing author and provided critical review of the manuscript. CJL directs the DMAC and is responsible for data management and primary analysis; she wrote statistical portions and data management portions of this manuscript. MAN is the project manager. She provides leadership in the design and implementation of this research protocol across all work groups and clinical sites and chairs the Clinical Research Committee. She wrote portions of this manuscript and contributed significantly to the editorial process. RL is an investigator and one of the two founding developers of the ASAP principles and protocol. She chairs the ASAP therapist committee. She wrote portions dealing with ASAP and several of the outcome measures and provided insightful and critical review of the entire manuscript. SB is a center coordinator (Emory) and clinical site coordinator. She participates in recruitment, screening, and treatment of participants, and contributed to protocol development/ revisions. She is a contributing author to this manuscript. CS is a clinical site coordinator (Long Beach), clinical center coordinator (California), and ASAP Intervention therapist. She chairs the CSC committee and is a contributing author of this manuscript. AR is a blinded evaluator and participates in the recruiting, screening and evaluating of study participants. She is a contributing author to this manuscript. SYC co-directs the DMAC and is responsible for database development and management. He wrote portions of the manuscript dealing with data management and adverse events. RH is the former center coordinator (NRH), clinical site coordinator at NRH and ASAP intervention therapist. He is a contributing author to this manuscript. SPA is the blinded statistician and DMAC consultant who serves on the Executive Committee. He was involved in proposal preparation and is a contributing author to this manuscript. All authors read and approved the final manuscript.
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Research Funding:
ICARE is funded jointly by NIH/NINDS (primary) and NICHD; Grant No. U01NS056256.
Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol
Abstract:
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© 2013 Winstein et al.; licensee BioMed Central Ltd.
