Project Summary
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 recent StrokeNet trial found that a 6-week course of intensive home-based daily arm motor telerehabilitation significantly improved arm function as well as global function in patients averaging 4 months post-stroke, with efficacy comparable to dose-matched therapy delivered in-clinic. A definitive trial that compares telerehabilitation with usual and customary care is now needed. This issue will be addressed in the “Telerehabilitation In The Home After Stroke: A Randomized, Controlled, Assessor-Blind Clinical Trial (The TR-2 Trial),” 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 of the TR-2 Trial 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. Selecting the right patients is challenging in stroke clinical practice and trials due to the enormous heterogeneity of this disease. Clinical measures incompletely predict therapy gains, but studies from many labs have found that the extent of injury to the corticospinal tract predicts arm motor gains after stroke. 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.
