title: Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  www.ClinicalTrials.gov Identifier: NCT00871715
authors: Division of Biokinesiology and Physical Therapy, Herman Ostrow School of Dentistry University of Southern California, Los Angeles, CA, USA. winstein@usc.edu
authors: Carolee J
authors: CJ
authors: Winstein
authors: Steven L
authors: SL
authors: Wolf
authors: Alexander W
authors: AW
authors: Dromerick
authors: Christianne J
authors: CJ
authors: Lane
authors: Monica A
authors: MA
authors: Nelsen
authors: Rebecca
authors: R
authors: Lewthwaite
authors: Sarah
authors: S
authors: Blanton
authors: Charro
authors: C
authors: Scott
authors: Aimee
authors: A
authors: Reiss
authors: Steven Yong
authors: SY
authors: Cen
authors: Rahsaan
authors: R
authors: Holley
authors: Stanley P
authors: SP
authors: Azen
mesh_terms: D000328:Adult; D001132:Arm / Q000503:physiopathology; D004185:Disability Evaluation; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis; D000071939:Stroke Rehabilitation; D013997:Time Factors