Dosage Frequency Effects on Treatment Outcomes Following Self-managed Digital Therapy: Retrospective Cohort Study.

BACKGROUND: Although the efficacy of high-dose speech-language therapy (SLT) for individuals with poststroke aphasia has been established in the literature, there is a gap in translating these research findings to clinical practice. Therefore, patients continue to receive suboptimal amounts of SLT, with negative consequences for their functional communication recovery. Recent research has identified self-managed digital health technology as one way to close the dosage gap by enabling high-intensity therapy unrestricted by clinician availability or other practical constraints. However, there is limited empirical evidence available to rehabilitation professionals to guide dose prescriptions for self-managed SLT despite their increasing use in the COVID-19 era and likely beyond. OBJECTIVE: This study aims to leverage real-world mobile health data to investigate the effects of varied dosage frequency on performance outcomes for individuals with poststroke speech, language, and cognitive deficits following a 10-week period of self-managed treatment via a commercially available digital health platform. METHODS: Anonymized data from 2249 poststroke survivors who used the Constant Therapy app between late 2016 and 2019 were analyzed. The data included therapy tasks spanning 13 different language and cognitive skill domains. For each patient, the weekly therapy dosage was calculated based on the median number of days per week of app use over the 10-week therapy period, binned into groups of 1, 2, 3, 4, or ≥5 days per week. Linear mixed-effects models were run to examine change in performance over time as a function of dosage group, with post hoc comparisons of slopes to evaluate the performance gain associated with each additional day of practice. RESULTS: Across all skill domains, linear mixed-effects model results showed that performance improvement was significantly greater for patients who practiced 2 (ß=.001; t15,355=2.37; P=.02), 3 (ß=.003; t9738=5.21; P<.001), 4 (ß=.005; t9289=7.82; P<.001), or ≥5 (ß=.005; t6343=8.14; P<.001) days per week compared with those who only practiced for 1 day per week. Post hoc comparisons confirmed an incremental dosage effect accumulating with each day of practice (ie, 1 day vs 2 days, 2 days vs 3 days, and 3 days vs 4 days), apart from 4 days versus ≥5 days of practice per week. The result of greater improvement for higher versus lower dosage frequency groups was true not only across all domains but also within a majority of individual subdomains. CONCLUSIONS: The findings from this study demonstrated that increased dosage frequency is associated with greater therapy gains over a 10-week treatment period of self-managed digital therapy. The use of real-world data maximizes the ecological validity of study results and makes the findings more generalizable to clinical settings. This study represents an important step toward the development of optimal dose recommendations for self-managed SLT.

A Virtual, Randomized, Control Trial of a Digital Therapeutic for Speech, Language, and Cognitive Intervention in Post-stroke Persons With Aphasia.

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.

Comparison of Therapy Practice at Home and in the Clinic: A Retrospective Analysis of the Constant Therapy Platform Data Set.

Background: Computer-based therapies can provide an affordable and practical alternative by providing frequent intervention for stroke survivors with chronic aphasia by allowing the opportunity for home exercise practice, however more evidence is needed. The goal of this retrospective analysis was to compare the time course of therapy engagement when therapy was targeted in the clinic or at home by post-stroke individuals. We examined if home users of the therapy were compliant in therapy and if this documented practice time was associated with improved outcomes similar to clinic patients who practiced under the guidance of a clinician. Methods: A retrospective analysis of anonymously aggregated data collected for 3,686 patients with post-stroke aphasia over the course of four years (2013-2017) was conducted. Participants either received therapy delivered through Constant Therapy only at home (N = 2,100) or only in the clinic (N = 1,577). Constant Therapy includes over 70 evidence-based therapies for language and cognitive skills. This program was individualized for each patient with targeted tasks that dynamically adapted to each individual's progress. Results: Patients with <60% accuracy were analyzed to determine how long it took them to reach >90% accuracy. Results showed that both home-therapy and clinic patients reached 90% accuracy on their tasks similarly (Median = 3 sessions), but the frequency of therapy was significantly different with 50% of home users receiving therapy at least every 2 days while 50% of clinic patients only had therapy once every 5 days (p < 0.001). Thus, home-therapy users were able to master tasks in a shorter time (median of 6 days) than clinic patients (median of 12 days) (p < 0.001). Conclusion: Outcomes of treatment are similar for home users and clinic patients indicating the potential usability of a home-based treatment program for rehabilitation for post-stroke aphasia.