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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

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Journal Title:

BMC Neurology

Volume:

Volume 13, Number 5

Publisher:

, Pages 1-19

Type of Work:

Article | Final Publisher PDF

Abstract:

Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. Discussion ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. Trial registration http://www.ClinicalTrials.gov webcite Identifier: NCT00871715

Copyright information:

© 2013 Winstein et al.; licensee BioMed Central Ltd.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 2.0 Generic License (http://creativecommons.org/licenses/by/2.0/).

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