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 versus 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 >= v25 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 versus DEUCC 0.14; 95% CI -0.05 to 0.33; p = 0.16; ASAP versus UCC -0.01; 95% CI -0.22 to 0.21; p = 0.94; and DEUCC versus UCC -0.14; 95% CI -0.32 to 0.05; p = 0.15). 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 versus DEUCC WMFT 1.8 seconds; 95% CI -0.8 to 4.5 seconds; p = 0.18; improved SIS 1%; 95% CI -12% to 13%; p = 0.54; ASAP versus UCC WMFT -0.6 seconds, 95% CI -3.8 to 2.6 seconds; p = 0.72; improved SIS 4%; 95% CI -9% to 16%; p = 0.48; and DEUCC versus UCC WMFT -2.1 seconds; 95% CI -4.5 to 0.3 seconds; p = 0.08; improved SIS 3%; 95% CI -9% to 15%; p = 0.22). 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.

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