Abstract Body: High doses of intensive rehabilitation therapy improve functional outcomes after stroke, but most patients do not receive this, for reasons that include limited access, difficulty traveling, and low motivation. Telehealth can address these obstacles. A definitive trial that compares telerehabilitation with usual and customary care is now needed.

This issue will be addressed in the current study, a controlled, assessor-blind, randomized, phase III superiority trial that will recruit 202 patients with substantial arm motor deficits 4 months after stroke onset and randomize them to [1] a 6-week course of intensive daily arm motor rehabilitation therapy or [2] usual care. Aim 1 hypothesizes that adding a 6-week course of intensive arm motor telerehabilitation to usual care results in superior functional outcomes compared to usual care alone. The primary outcome measures arm function (Action Research Arm Test); the secondary outcome measures global function (modified Rankin Scale). Aim 2 will examine the predictive power of an imaging biomarker. The biological model underlying intensive arm motor telerehabilitation is that therapy activates multiple brain motor circuits, with the corticospinal tract being the final efferent pathway by which treatment gains are expressed, and so an intact corticospinal tract is needed to benefit from therapy. The specific hypothesis is that any benefit of telerehabilitation over usual care is a function of the extent to which the corticospinal tract is preserved. Aim 3 will evaluate the health economic impacts of the two treatment groups, with a focus on patient health-related quality of life, as the effects of telerehabilitation therapy must be considered in the broader context of healthcare utilization.

Stroke remains a major cause of disability, and motor deficits are a major contributor. Rehabilitation therapy after stroke is generally provided at a very low dose, can be hard to access, and is often not very motivating. Our telerehabilitation program overcomes these barriers, was efficacious in phase I and phase II multisite trials, and will now be examined in comparison to usual care. The TR-2 trial is expected to generate definitive evidence that rehab therapy helps post-stroke at a time when many medical systems stop providing rehab care and so stands to change clinical practice worldwide.