Overview

The ICARE is about arm and hand recovery after stroke. We are testing an evidence-based arm therapy called Accelerated Skill Acquisition Program (ASAP) which combines challenging, intensive and meaningful practice of tasks of the participant's choice (e.g. handwriting, carrying groceries) compared to two standard types of outpatient occupational therapy: 1) Dose Equivalent Usual & Customary Care (DEUCC) 30 hours of occupational therapy scheduled 3x/week over 10 weeks and 2) Usual & Customary Care (UCC) delivered at the dosage indicated on your prescription and common for that outpatient setting. UCC may vary but is likely to be less than 30 hours and in some case may be not therapy. We will randomize 360 individuals from multiple sites within three centers (Atlanta GA, Los Angeles CA and Washington DC) within 14 to 106 days of stroke onset with mild to moderate upper extremity impairment.

Participants assigned to the DEUCC and UCC study group will receive traditional outpatient occupational therapy as it is typically practiced in the outpatient clinic. The scope of typical therapy for patients with stroke may be more comprehensive than the focused package defined as ASAP. It may address issues or use interventions directed at issues other than the arm most affected by the stroke, e.g. perceptual deficits, splint and equipment fabrication, modalities, exercise, activities of daily living training and vocation-related rehabilitation.

The primary aim of this study is to compare the ASAP to a dose equivalent usual and customary occupational high dose therapy group. The secondary aims are (1) comparing ASAP to a true usual and customary occupational therapy group (low dose) and (2) comparing the high dose usual and customary occupational therapy group to the low dose usual and customary occupational therapy group.

If our primary hypothesis is supported, the findings of the ICARE could change current patterns during post-acute outpatient therapy for those with mild to moderate baseline impairments. Even if our primary hypothesis is not supported, our secondary aim to compare the effects of DEUCC to that of UCC has relevance for determining if dose alone matters for functional outcomes . If our dose hypothesis is supported, the findings of ICARE could establish recommendations for the number of outpatient visits necessary to achieve clinically meaningful outcomes and for which no guidelines currently exist. Further, current and future experimental interventions such as pharmacological agents, gene therapy, stem cell implants, and direct cortical stimulation inevitably will be combined with optimal standardized and effective neurorehabilitation protocols to organize neuroplastic effects and maximize benefits.