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Original Investigation |

Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke The ICARE Randomized Clinical Trial

Carolee J. Winstein, PhD1; Steven L. Wolf, PhD2; Alexander W. Dromerick, MD3; Christianne J. Lane, PhD1; Monica A. Nelsen, DPT1; Rebecca Lewthwaite, PhD1; Steven Yong Cen, PhD1; Stanley P. Azen, PhD1 ; for the Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team
[+] Author Affiliations
1University of Southern California, Los Angeles
2Emory University, Atlanta, Georgia
3MedStar National Rehabilitation Hospital, Washington, DC
JAMA. 2016;315(6):571-581. doi:10.1001/jama.2016.0276.
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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

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Figure 1.
Participant Flow in the ICARE Trial

ASAP indicates Accelerated Skill Acquisition Program; DEUCC, dose-equivalent usual and customary care; UCC, monitoring-only usual and customary care. Reasons for exclusion are not exclusive. Adherence in the ASAP and DEUCC was defined as 27 hours or more of prescribed treatment; there was no adherence data collected for the UCC group. The study was designed with an estimated a priori attrition rate of 25%; actual attrition rates by group were considerably lower, ranging from 9% to 16% across groups. Attrition rate of withdrawal across groups was not statistically significant (P = .24). Evaluable data at 12 months ranged from 79% to 88%; for intention-to-treat analyses, multiple imputation models were used to estimate end-of-study data for primary analyses.

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Figure 2.
Longitudinal Changes in Unadjusted Imputed Mean Scores Across Months for the Primary and Secondary Outcomes

Primary outcome, log-transformed Wolf Motor Function Test (WMFT) time score (left) and secondary outcomes, WMFT time score (center) and patient-reported Stroke Impact Scale (SIS) hand function subscale score (right). N=119 in the Accelerated Skill Acquisition Program (ASAP) group; n = 120 in the dose-equivalent usual and customary care (DEUCC) group; and n = 122 in the monitoring-only usual and customary care (UCC) group. Timing of each assessment after randomization was as follows: 0 months = baseline; 4 months = end of therapy; 6 months = follow-up; and 12 months = end of study. Statistical analyses were performed on the imputed intention-to-treat data set. Error bars represent 95% CIs.

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