Michelle Braley1,2,3, Jordyn Sims Pierce4,5, Sadhvi Saxena6, Emily De Oliveira2,7, Laura Taraboanta3, Veera Anantha4, Shaheen E Lakhan3,8,9, Swathi Kiran4,10. 1. Department of Communication Sciences and Disorders, MGH Institute of Health Professions, Charlestown, MA, United States. 2. Spaulding Rehabilitation Hospital, Charlestown, MA, United States. 3. The Learning Corp, Newton, MA, United States. 4. Constant Therapy Health, Lexington, MA, United States. 5. Pierce Health Consultants, Lenox, MA, United States. 6. Department of Neurology, Johns Hopkins School of Medicine, Baltimore, MD, United States. 7. Definitive Healthcare, Boston, MA, United States. 8. Global Neuroscience Initiative Foundation, Boston, MA, United States. 9. Virginia Tech, Blacksburg, VA, United States. 10. Sargent College of Health and Rehabilitation Sciences, Boston University, Boston, MA, United States.
Abstract
Background: Post-stroke aphasia is a chronic condition that impacts people's daily functioning and communication for many years after a stroke. Even though these individuals require sustained rehabilitation, they face extra burdens to access care due to shortages in qualified clinicians, insurance limitations and geographic access. There is a need to research alternative means to access intervention remotely, such as in the case of this study using a digital therapeutic. Objective: To assess the feasibility and clinical efficacy of a virtual speech, language, and cognitive digital therapeutic for individuals with post-stroke aphasia relative to standard of care. Methods:Thirty two participants completed the study (experimental: average age 59.8 years, 7 female, 10 male, average education: 15.8 years, time post-stroke: 53 months, 15 right handed, 2 left handed; control: average age 64.2 years, 7 female, 8 male, average education: 15.3 years, time post-stroke: 36.1 months, 14 right handed, 1 left handed). Patients in the experimental group received 10 weeks of treatment using a digital therapeutic, Constant Therapy-Research (CT-R), for speech, language, and cognitive therapy, which provides evidence-based, targeted therapy with immediate feedback for users that adjusts therapy difficulty based on their performance. Patients in the control group completed standard of care (SOC) speech-language pathology workbook pages. Results: This study provides Class II evidence that with the starting baseline WAB-AQ score, adjusted by -0.69 for every year of age, and by 0.122 for every month since stroke, participants in the CT-R group had WAB-AQ scores 6.43 higher than the workbook group at the end of treatment. Additionally, secondary outcome measures included the WAB-Language Quotient, WAB-Cognitive Quotient, Brief Test of Adult Cognition by Telephone (BTACT), and Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39), with significant changes in BTACT verbal fluency subtest and the SAQOL-39 communication and energy scores for both groups. Conclusions: Overall, this study demonstrates the feasibility of a fully virtual trial for patients with post-stroke aphasia, especially given the ongoing COVID19 pandemic, as well as a safe, tolerable, and efficacious digital therapeutic for language/cognitive rehabilitation. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04488029.
RCT Entities:
Background: Post-stroke aphasia is a chronic condition that impacts people's daily functioning and communication for many years after a stroke. Even though these individuals require sustained rehabilitation, they face extra burdens to access care due to shortages in qualified clinicians, insurance limitations and geographic access. There is a need to research alternative means to access intervention remotely, such as in the case of this study using a digital therapeutic. Objective: To assess the feasibility and clinical efficacy of a virtual speech, language, and cognitive digital therapeutic for individuals with post-stroke aphasia relative to standard of care. Methods: Thirty two participants completed the study (experimental: average age 59.8 years, 7 female, 10 male, average education: 15.8 years, time post-stroke: 53 months, 15 right handed, 2 left handed; control: average age 64.2 years, 7 female, 8 male, average education: 15.3 years, time post-stroke: 36.1 months, 14 right handed, 1 left handed). Patients in the experimental group received 10 weeks of treatment using a digital therapeutic, Constant Therapy-Research (CT-R), for speech, language, and cognitive therapy, which provides evidence-based, targeted therapy with immediate feedback for users that adjusts therapy difficulty based on their performance. Patients in the control group completed standard of care (SOC) speech-language pathology workbook pages. Results: This study provides Class II evidence that with the starting baseline WAB-AQ score, adjusted by -0.69 for every year of age, and by 0.122 for every month since stroke, participants in the CT-R group had WAB-AQ scores 6.43 higher than the workbook group at the end of treatment. Additionally, secondary outcome measures included the WAB-Language Quotient, WAB-Cognitive Quotient, Brief Test of Adult Cognition by Telephone (BTACT), and Stroke and Aphasia Quality of Life Scale 39 (SAQOL-39), with significant changes in BTACT verbal fluency subtest and the SAQOL-39 communication and energy scores for both groups. Conclusions: Overall, this study demonstrates the feasibility of a fully virtual trial for patients with post-stroke aphasia, especially given the ongoing COVID19 pandemic, as well as a safe, tolerable, and efficacious digital therapeutic for language/cognitive rehabilitation. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04488029.
Authors: Rebecca Palmer; Munyaradzi Dimairo; Nicholas Latimer; Elizabeth Cross; Marian Brady; Pam Enderby; Audrey Bowen; Steven Julious; Madeleine Harrison; Abualbishr Alshreef; Ellen Bradley; Arjun Bhadhuri; Tim Chater; Helen Hughes; Helen Witts; Esther Herbert; Cindy Cooper Journal: Health Technol Assess Date: 2020-04 Impact factor: 4.014
Authors: Carolee J Winstein; Joel Stein; Ross Arena; Barbara Bates; Leora R Cherney; Steven C Cramer; Frank Deruyter; Janice J Eng; Beth Fisher; Richard L Harvey; Catherine E Lang; Marilyn MacKay-Lyons; Kenneth J Ottenbacher; Sue Pugh; Mathew J Reeves; Lorie G Richards; William Stiers; Richard D Zorowitz Journal: Stroke Date: 2016-05-04 Impact factor: 7.914
Authors: Claire Cordella; Michael Munsell; Jason Godlove; Veera Anantha; Mahendra Advani; Swathi Kiran Journal: J Med Internet Res Date: 2022-07-20 Impact factor: 7.076
Authors: Anna Marin; Renée DeCaro; Kylie Schiloski; Ala'a Elshaar; Brigid Dwyer; Ana Vives-Rodriguez; Rocco Palumbo; Katherine Turk; Andrew Budson Journal: JMIR Form Res Date: 2022-09-12
Authors: Esther S Kim; Laura Laird; Carlee Wilson; Till Bieg; Philip Mildner; Sebastian Möller; Raimund Schatz; Stephanie Schwarz; Robert Spang; Jan-Niklas Voigt-Antons; Elizabeth Rochon Journal: JMIR Res Protoc Date: 2021-07-02