Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial

Abstract

Importance: Many patients receive suboptimal rehabilitation therapy doses after stroke owing to limited access to therapists and difficulty with transportation, and their knowledge about stroke is often limited. Telehealth can potentially address these issues.

Objectives: To determine whether treatment targeting arm movement delivered via a home-based telerehabilitation (TR) system has comparable efficacy with dose-matched, intensity-matched therapy delivered in a traditional in-clinic (IC) setting, and to examine whether this system has comparable efficacy for providing stroke education.

Design, setting, and participants: In this randomized, assessor-blinded, noninferiority trial across 11 US sites, 124 patients who had experienced stroke 4 to 36 weeks prior and had arm motor deficits (Fugl-Meyer [FM] score, 22-56 of 66) were enrolled between September 18, 2015, and December 28, 2017, to receive telerehabilitation therapy in the home (TR group) or therapy at an outpatient rehabilitation therapy clinic (IC group). Primary efficacy analysis used the intent-to-treat population.

Interventions: Participants received 36 sessions (70 minutes each) of arm motor therapy plus stroke education, with therapy intensity, duration, and frequency matched across groups.

Main outcomes and measures: Change in FM score from baseline to 4 weeks after end of therapy and change in stroke knowledge from baseline to end of therapy.

Results: A total of 124 participants (34 women and 90 men) had a mean (SD) age of 61 (14) years, a mean (SD) baseline FM score of 43 (8) points, and were enrolled a mean (SD) of 18.7 (8.9) weeks after experiencing a stroke. Among those treated, patients in the IC group were adherent to 33.6 of the 36 therapy sessions (93.3%) and patients in the TR group were adherent to 35.4 of the 36 assigned therapy sessions (98.3%). Patients in the IC group had a mean (SD) FM score change of 8.36 (7.04) points from baseline to 30 days after therapy (P < .001), while those in the TR group had a mean (SD) change of 7.86 (6.68) points (P < .001). The covariate-adjusted mean FM score change was 0.06 (95% CI, -2.14 to 2.26) points higher in the TR group (P = .96). The noninferiority margin was 2.47 and fell outside the 95% CI, indicating that TR is not inferior to IC therapy. Motor gains remained significant when patients enrolled early (<90 days) or late (≥90 days) after stroke were examined separately.

Conclusions and relevance: Activity-based training produced substantial gains in arm motor function regardless of whether it was provided via home-based telerehabilitation or traditional in-clinic rehabilitation. The findings of this study suggest that telerehabilitation has the potential to substantially increase access to rehabilitation therapy on a large scale.

Trial registration: ClinicalTrials.gov identifier: NCT02360488.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Cramer reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study; serving as a consultant for and receiving personal fees from Roche, AbbVie, Constant Pharmaceutical, Microtransponder, Dart Neuroscience, Neurolutions, Regenera, SanBio, Stemedica, TRCare, and Toyama outside the submitted work; and having a patent pending to No. 15/254,029 “Systems And Methods For Facilitating Rehabilitation Therapy.” Ms Dodakian reported receiving personal fees from TRCare outside the submitted work and having a patent to TRCare licensed and with royalties paid. Mr Le reported receiving personal fees from TRCare during the conduct of the study and outside the submitted work and holding a patent to UCI Case No. 2016-117 issued, licensed, and with royalties paid. Ms See reported receiving personal fees from TRCare outside the submitted work and holding a patent to 2016-117 licensed and with royalties paid. Ms Augsburger reported receiving personal fees from TRCare outside the submitted work. Dr McKenzie reported holding a patent for No. 15/254,029; UCI Case No. 2016-117-2 US issued and licensed and serving as a consultant for TRCare after the study was completed. Mr Zhou reported personal fees from TRCare outside the submitted work and holding a patent to No. 2016-117, Short title: A System and Method for Telerehabilitation, licensed and with royalties paid. Dr Cassidy reported receiving grants from NIH during the conduct of the study and outside the submitted work and having a patent pending and with royalties paid. Dr Barrett reported receiving support from Kessler Foundation during the conduct of the study; personal fees from Medscape/emedicine; and grants from Brightcloud Inc and Dart Neuroscience outside the submitted work. Dr Knutson reported receiving grant U01NS091951 from the NIH during the conduct of the study; and having a patent to US 8,165,685 issued and licensed. Dr Edwards reported receiving grants and nonfinancial support from Ekso Bionics Inc and grants from Nexstim and serving on the scientific advisory boards for Nexstim and Ekso Bionics outside the submitted work. Dr Putrino reported receiving grants from the NIH during the conduct of the study. Dr Ngo reported receiving grants from the NIH during the conduct of the study. Dr Tirschwell reported receiving grants from the National Institute of Neurological Disorders and Stroke (NINDS)/NIH during the conduct of the study. Dr Zafonte reported receiving royalties from Oakstone and Demos Publishing; serving on the Scientific Advisory Board of Myomo, Oxeia Biopharma, Biodirection, and ElMINDA; and being funded by the NFL Players Association. Dr Zhao reported receiving grants from the NINDS during the conduct of the study. Ms Spilker reported receiving grants from the NINDS/NIH during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram of Study Enrollment

Figure 2.. Examples of Telerehabilitation Therapy Content