PMID- 26864411 OWN - NLM STAT- MEDLINE DCOM- 20160216 LR - 20231111 IS - 1538-3598 (Electronic) IS - 0098-7484 (Print) IS - 0098-7484 (Linking) VI - 315 IP - 6 DP - 2016 Feb 9 TI - Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. PG - 571-81 LID - 10.1001/jama.2016.0276 [doi] AB - IMPORTANCE: Clinical trials suggest that higher doses of task-oriented training are superior to current clinical practice for patients with stroke with upper extremity motor deficits. OBJECTIVE: To compare the efficacy of a structured, task-oriented motor training program vs usual and customary occupational therapy (UCC) during stroke rehabilitation. DESIGN, SETTING, AND PARTICIPANTS: Phase 3, pragmatic, single-blind randomized trial among 361 participants with moderate motor impairment recruited from 7 US hospitals over 44 months, treated in the outpatient setting from June 2009 to March 2014. INTERVENTIONS: Structured, task-oriented upper extremity training (Accelerated Skill Acquisition Program [ASAP]; n = 119); dose-equivalent occupational therapy (DEUCC; n = 120); or monitoring-only occupational therapy (UCC; n = 122). The DEUCC group was prescribed 30 one-hour sessions over 10 weeks; the UCC group was only monitored, without specification of dose. MAIN OUTCOMES AND MEASURES: The primary outcome was 12-month change in log-transformed Wolf Motor Function Test time score (WMFT, consisting of a mean of 15 timed arm movements and hand dexterity tasks). Secondary outcomes were change in WMFT time score (minimal clinically important difference [MCID] = 19 seconds) and proportion of patients improving >/=25 points on the Stroke Impact Scale (SIS) hand function score (MCID = 17.8 points). RESULTS: Among the 361 randomized patients (mean age, 60.7 years; 56% men; 42% African American; mean time since stroke onset, 46 days), 304 (84%) completed the 12-month primary outcome assessment; in intention-to-treat analysis, mean group change scores (log WMFT, baseline to 12 months) were, for the ASAP group, 2.2 to 1.4 (difference, 0.82); DEUCC group, 2.0 to 1.2 (difference, 0.84); and UCC group, 2.1 to 1.4 (difference, 0.75), with no significant between-group differences (ASAP vs DEUCC: 0.14; 95% CI, -0.05 to 0.33; P = .16; ASAP vs UCC: -0.01; 95% CI, -0.22 to 0.21; P = .94; and DEUCC vs UCC: -0.14; 95% CI, -0.32 to 0.05; P = .15). Secondary outcomes for the ASAP group were WMFT change score, -8.8 seconds, and improved SIS, 73%; DEUCC group, WMFT, -8.1 seconds, and SIS, 72%; and UCC group, WMFT, -7.2 seconds, and SIS, 69%, with no significant pairwise between-group differences (ASAP vs DEUCC: WMFT, 1.8 seconds; 95% CI, -0.8 to 4.5 seconds; P = .18; improved SIS, 1%; 95% CI, -12% to 13%; P = .54; ASAP vs UCC: WMFT, -0.6 seconds, 95% CI, -3.8 to 2.6 seconds; P = .72; improved SIS, 4%; 95% CI, -9% to 16%; P = .48; and DEUCC vs UCC: WMFT, -2.1 seconds; 95% CI, -4.5 to 0.3 seconds; P = .08; improved SIS, 3%; 95% CI, -9% to 15%; P = .22). A total of 168 serious adverse events occurred in 109 participants, resulting in 8 patients withdrawing from the study. CONCLUSIONS AND RELEVANCE: Among patients with motor stroke and primarily moderate upper extremity impairment, use of a structured, task-oriented rehabilitation program did not significantly improve motor function or recovery beyond either an equivalent or a lower dose of UCC upper extremity rehabilitation. These findings do not support superiority of this program among patients with motor stroke and primarily moderate upper extremity impairment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00871715. FAU - Winstein, Carolee J AU - Winstein CJ AD - University of Southern California, Los Angeles. FAU - Wolf, Steven L AU - Wolf SL AD - Emory University, Atlanta, Georgia. FAU - Dromerick, Alexander W AU - Dromerick AW AD - MedStar National Rehabilitation Hospital, Washington, DC. FAU - Lane, Christianne J AU - Lane CJ AD - University of Southern California, Los Angeles. FAU - Nelsen, Monica A AU - Nelsen MA AD - University of Southern California, Los Angeles. FAU - Lewthwaite, Rebecca AU - Lewthwaite R AD - University of Southern California, Los Angeles. FAU - Cen, Steven Yong AU - Cen SY AD - University of Southern California, Los Angeles. FAU - Azen, Stanley P AU - Azen SP AD - University of Southern California, Los Angeles. CN - Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team LA - eng SI - ClinicalTrials.gov/NCT00871715 GR - U01 NS056256/NS/NINDS NIH HHS/United States GR - R01 NS058755/NS/NINDS NIH HHS/United States GR - U01NS056256/NS/NINDS NIH HHS/United States PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PL - United States TA - JAMA JT - JAMA JID - 7501160 SB - IM CIN - JAMA. 2016 Jul 5;316(1):101-2. PMID: 27380354 CIN - JAMA. 2016 Jul 5;316(1):102. PMID: 27380356 MH - Aged MH - Arm/physiopathology MH - Female MH - Hand/physiopathology MH - Humans MH - Male MH - Middle Aged MH - Motor Skills MH - Motor Skills Disorders/etiology/*rehabilitation MH - Occupational Therapy/*methods MH - Recovery of Function MH - Single-Blind Method MH - Stroke/*complications MH - Task Performance and Analysis PMC - PMC4795962 MID - NIHMS762594 COIS- Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. FIR - Winstein, Carolee J IR - Winstein CJ FIR - Nelsen, Monica A IR - Nelsen MA FIR - Bandich, Jennifer IR - Bandich J FIR - Massimo, Shannon IR - Massimo S FIR - Haines, Michelle IR - Haines M FIR - Hatchett, Patricia IR - Hatchett P FIR - Rowe, Veronica T IR - Rowe VT FIR - McLean, Claire IR - McLean C FIR - Yang, Arlene IR - Yang A FIR - Tabak, Rachel IR - Tabak R FIR - McNealus, Kristin IR - McNealus K FIR - Strickland, Veronica IR - Strickland V FIR - Kasayama, Julie Y IR - Kasayama JY FIR - Lewthwaite, Rebecca IR - Lewthwaite R FIR - Wagenheim, Burl IR - Wagenheim B FIR - Liu, Brent IR - Liu B FIR - Wang, Ximing IR - Wang X FIR - Ma, Kevin IR - Ma K FIR - Russak, David IR - Russak D FIR - Dang, Nhi IR - Dang N FIR - Wongthipkongka, Katie IR - Wongthipkongka K FIR - Hou, Yanshu IR - Hou Y FIR - Duff, Sue IR - Duff S FIR - Nelson, Richard IR - Nelson R FIR - Wolf, Steven L IR - Wolf SL FIR - Blanton, Sarah IR - Blanton S FIR - Burke, David IR - Burke D FIR - Murphy, Susan IR - Murphy S FIR - Reiss, Aimee IR - Reiss A FIR - Bidgood, Marsha IR - Bidgood M FIR - Wolf, Lois IR - Wolf L FIR - Holecek, Gina IR - Holecek G FIR - Hite, Megan IR - Hite M FIR - Tober, Melissa IR - Tober M FIR - Zeforino, Sara IR - Zeforino S FIR - Dromerick, Alexander W IR - Dromerick AW FIR - Edwardson, Matthew A IR - Edwardson MA FIR - Brady, Kathaleen IR - Brady K FIR - Holley, Rahsaan IR - Holley R FIR - Monroe, Lori IR - Monroe L FIR - Elrod, Matthew IR - Elrod M FIR - Burdekin, Kate IR - Burdekin K FIR - Quitania, Siena IR - Quitania S FIR - Loftin, Sara IR - Loftin S FIR - Gianetti, Margot IR - Gianetti M FIR - Feldman, Rebecca IR - Feldman R FIR - Tiffany, Deirdra IR - Tiffany D FIR - Simons, Annie IR - Simons A FIR - Halstead, Lauro IR - Halstead L FIR - Desai, Kanan IR - Desai K FIR - Chan, Hansen IR - Chan H FIR - Barth, Jessica IR - Barth J FIR - Mohapatra, Sambit IR - Mohapatra S FIR - Pappe, Carrie IR - Pappe C FIR - Barrett, Nora E IR - Barrett NE FIR - Tinoco, Ericka Breceda IR - Tinoco EB FIR - Nichols, Diane IR - Nichols D FIR - Lichy, Alison IR - Lichy A FIR - Cross, Melissa IR - Cross M FIR - Levy, Mara IR - Levy M FIR - Guercin, Connie IR - Guercin C FIR - Tracy, Teresa IR - Tracy T FIR - Brettschneider, Jutta IR - Brettschneider J FIR - Fieldsend, Molly IR - Fieldsend M FIR - Underwood, Janice IR - Underwood J FIR - Lane, Christianne J IR - Lane CJ FIR - Azen, Stanley P IR - Azen SP FIR - Cen, Steven Yong IR - Cen SY FIR - Gardner, James IR - Gardner J FIR - Ding, Li IR - Ding L FIR - Hahn, Christopher IR - Hahn C FIR - He, Jiaxiu IR - He J FIR - Park, Caron IR - Park C FIR - Wen, Ge IR - Wen G FIR - Takayanagi, Miwa IR - Takayanagi M FIR - Xiang, Anny IR - Xiang A FIR - Burtman-Regalado, Candice IR - Burtman-Regalado C FIR - Scott, Charro IR - Scott C FIR - Adams, Richard IR - Adams R FIR - Hoang, Diehma IR - Hoang D FIR - Huang, Audrey IR - Huang A FIR - Massimo, Shannon IR - Massimo S FIR - Jenq, Shuywe IR - Jenq S FIR - Kaplan, Stephanie IR - Kaplan S FIR - Patterson, David IR - Patterson D FIR - Timple, Cathelyn IR - Timple C FIR - Mendon, Shelia IR - Mendon S FIR - Hazen, Jacob IR - Hazen J FIR - Ouellette, Deborah IR - Ouellette D FIR - Gallardo, Oscar IR - Gallardo O FIR - Lazouras, Covey IR - Lazouras C FIR - Zhang, Xiao-Ling IR - Zhang XL FIR - Bina, Babak IR - Bina B FIR - Torres, Joaquin IR - Torres J FIR - Tamayo, Rosemary IR - Tamayo R FIR - Rodriguez, Byanca IR - Rodriguez B FIR - Lin, Chester IR - Lin C FIR - Villegas, Alex IR - Villegas A FIR - Smith, Claire IR - Smith C FIR - Wolfson, Mark IR - Wolfson M FIR - Love, Kelly IR - Love K FIR - Riggs, Richard IR - Riggs R FIR - Demond, Michelle IR - Demond M FIR - Roberts, Pamela IR - Roberts P FIR - Solis, Nuvia IR - Solis N FIR - Benham, Sara IR - Benham S FIR - Fakheri, Karina IR - Fakheri K FIR - Davis, Aimee IR - Davis A FIR - MacCormack, B A IR - MacCormack B FIR - Hegde, Sunil IR - Hegde S FIR - Kushi, Cynthia IR - Kushi C FIR - Ohanessians, Ilin IR - Ohanessians I FIR - Parkinson, Michael IR - Parkinson M FIR - Burch, Miriam IR - Burch M FIR - Harvey, Richard L IR - Harvey RL FIR - Coull, Bruce IR - Coull B FIR - Nadeau, Stephen IR - Nadeau S FIR - Parides, Michael IR - Parides M FIR - Sisto, Sue Ann IR - Sisto SA FIR - Janis, Scott IR - Janis S FIR - Cordell, Janice IR - Cordell J FIR - Ritz, Louise IR - Ritz L FIR - Michel, Mary Ellen IR - Michel ME FIR - Cramer, Steven C IR - Cramer SC FIR - See, Jill IR - See J EDAT- 2016/02/13 06:00 MHDA- 2016/02/18 06:00 PMCR- 2016/03/17 CRDT- 2016/02/12 06:00 PHST- 2016/02/12 06:00 [entrez] PHST- 2016/02/13 06:00 [pubmed] PHST- 2016/02/18 06:00 [medline] PHST- 2016/03/17 00:00 [pmc-release] AID - 2488308 [pii] AID - 10.1001/jama.2016.0276 [doi] PST - ppublish SO - JAMA. 2016 Feb 9;315(6):571-81. doi: 10.1001/jama.2016.0276.