NASHVILLE — A two-fold increase in dose of outpatient arm and hand therapy was not superior to usual occupational therapy (OT) in motor performance improvements for patients following stroke, indicating to researchers that more is not necessarily better.
Carolee J. Winstein, PhD, PT, of the University of Southern California in Los Angeles, presented the findings of the ICARE trial at the International Stroke Conference 2015.
According to study background, the Accelerated Skill Acquisition Program (ASAP) is a principle-based, structured, task-oriented intervention aimed at skill acquisition, capacity building, and motivational enhancements in patients following stroke. In the study, the frequency of therapy in the ASAP and dose-equivalent OT groups were the same, whereas the usual OT dose was not controlled.
The primary endpoint of ICARE was motor performance at the end of the study (12 months, roughly 13.5 months after stroke), and the secondary endpoint was motor performance at the end of therapy (4 months, roughly 5.5 months after stroke).
In all, 11,051 patients were screened between June 2009 and February 2013, of whom 10,690 were excluded. The remaining 361 patients (mean age, 60.7 ± 12.5 years; 56.2% men; 42.4% African American) were randomly assigned to one of three groups: ASAP (n=119); dose-equivalent usual OT (n=120); or usual OT (n=122).
In a dose-frequency analysis, 79% of the ASAP group and 74% of the dose-equivalent group received at least 27 to 30 hours of treatment, whereas those in the usual OT group received an average of only 11.2 hours of treatment.
Winstein and colleagues reported a substantial mean improvement in motor performance score (46%), but the differences between groups in the primary and secondary endpoints did not significantly differ.
However, when compared with the dose-equivalent group, the ASAP group did have significant improvements in the following: physical function and strength in the patient-reported Stroke Impact Scale (SIS); Confidence in Arm and Hand Movement; and Reintegration to Normal Living Index.
There were no significant differences in the primary or secondary endpoints between the dose-equivalent and usual OT groups.
In her presentation, Winstein listed some caveats for the studies findings, including the considerable range of doses in the usual OT group (0-46 hours), which warrant a secondary analysis; and the generalizability of the findings, which are relevant primarily for the early outpatient setting after stroke and for those with moderately impaired arm and hand motion.
For more coverage of the International Stroke Conference 2015, go here.
Winstein C et al. Late-Breaking Trial #15. Presented at: International Stroke Conference 2015; Feb. 11-13, 2015; Nashville, Tennessee.