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

Abstract

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.

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.

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.