Steven C Cramer1, Lucy Dodakian1, Vu Le1, Jill See1, Renee Augsburger1,2, Alison McKenzie1,2,3, Robert J Zhou1,2, Nina L Chiu1,2, Jutta Heckhausen4, Jessica M Cassidy1,2, Walt Scacchi5, Megan Therese Smith6, A M Barrett7,8, Jayme Knutson9, Dylan Edwards10, David Putrino11, Kunal Agrawal12, Kenneth Ngo13, Elliot J Roth14, David L Tirschwell15, Michelle L Woodbury16, Ross Zafonte17,18,19,20, Wenle Zhao21, Judith Spilker22, Steven L Wolf23,24, Joseph P Broderick22, Scott Janis25. 1. Department of Neurology, University of California, Irvine. 2. Sue & Bill Gross Stem Cell Research Center, University of California, Irvine. 3. Department of Physical Therapy, Chapman University, Irvine, California. 4. Department of Psychological Science, University of California, Irvine. 5. Institute for Software Research, University of California, Irvine. 6. Department of Statistics, University of California, Irvine. 7. Department of Stroke Rehabilitation Research, Kessler Foundation, West Orange, New Jersey. 8. Department of Stroke Rehabilitation, Kessler Institute for Rehabilitation, West Orange, New Jersey. 9. Department of Physical Medicine and Rehabilitation, MetroHealth System, Case Western Reserve University, Cleveland, Ohio. 10. Brain Stimulation and Robotics Laboratory, Burke Neurological Institute, White Plains, New York. 11. Department of Telemedicine and Virtual Rehabilitation, Burke Medical Research Institute, White Plains, New York. 12. Department of Clinical Neurosciences, University of California, San Diego, La Jolla. 13. Brooks Rehabilitation Clinical Research Center, Brooks Rehabilitation, Jacksonville, Florida. 14. Department of Physical Medicine and Rehabilitation, Northwestern University, Chicago, Illinois. 15. Department of Neurology, University of Washington, Seattle. 16. Department of Health Science and Research, Medical University of South Carolina, Charleston. 17. Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Boston, Massachusetts. 18. Massachusetts General Hospital, Boston. 19. Brigham and Women's Hospital, Boston, Massachusetts. 20. Harvard Medical School, Boston, Massachusetts. 21. Department of Public Health Sciences, Medical University of South Carolina, Charleston. 22. Department of Neurology, University of Cincinnati, Cincinnati, Ohio. 23. Division of Physical Therapy Education, Department of Rehabilitation Medicine, Emory University, Atlanta, Georgia. 24. Atlanta Veterans Affairs Health Care System, Center for Visual and Neurocognitive Rehabilitation, Decatur, Georgia. 25. National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.
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.
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.
Authors: Enrique C Leira; Andrew N Russman; José Biller; Devin L Brown; Cheryl D Bushnell; Valeria Caso; Angel Chamorro; Claire J Creutzfeldt; Salvador Cruz-Flores; Mitchell S V Elkind; Pierre Fayad; Michael T Froehler; Larry B Goldstein; Nicole R Gonzales; Brian Kaskie; Pooja Khatri; Sarah Livesay; David S Liebeskind; Jennifer J Majersik; Asma M Moheet; Jose G Romano; Nerses Sanossian; Lauren H Sansing; Brian Silver; Alexis N Simpkins; Wade Smith; David L Tirschwell; David Z Wang; Dileep R Yavagal; Bradford B Worrall Journal: Neurology Date: 2020-05-08 Impact factor: 9.910
Authors: Steven C Cramer; Vu Le; Jeffrey L Saver; Lucy Dodakian; Jill See; Renee Augsburger; Alison McKenzie; Robert J Zhou; Nina L Chiu; Jutta Heckhausen; Jessica M Cassidy; Walt Scacchi; Megan Therese Smith; A M Barrett; Jayme Knutson; Dylan Edwards; David Putrino; Kunal Agrawal; Kenneth Ngo; Elliot J Roth; David L Tirschwell; Michelle L Woodbury; Ross Zafonte; Wenle Zhao; Judith Spilker; Steven L Wolf; Joseph P Broderick; Scott Janis Journal: Neurology Date: 2021-02-15 Impact factor: 9.910
Authors: Mariana Ortiz-Piña; Pablo Molina-Garcia; Pedro Femia; Maureen C Ashe; Lydia Martín-Martín; Susana Salazar-Graván; Zeus Salas-Fariña; Rafael Prieto-Moreno; Yolanda Castellote-Caballero; Fernando Estevez-Lopez; Patrocinio Ariza-Vega Journal: Int J Environ Res Public Health Date: 2021-05-20 Impact factor: 3.390