Implementation and effects of an information technology-based intervention to support speech and language therapy among stroke patients with aphasia: protocol for a virtual randomized controlled trial
Open accessPublished version of a preprint
Abstract
Background: Mobile app–based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia as adjuncts or substitutes for traditional in-person therapy approaches. These apps can increase the intensity of treatment and have resulted in meaningful outcomes across several domains. Objective: VoiceAdapt is a mobile therapy app designed with user and stakeholder feedback within a user-centered design framework. VoiceAdapt uses two evidence-based lexical retrieval treatments to help people with aphasia in improving their naming abilities through interactions with the app. The purpose of the randomized controlled trial (RCT) proposed here is to examine the feasibility and clinical efficacy of training with VoiceAdapt on the language and communication outcomes of people with aphasia. Methods: A multicenter RCT is being conducted at two locations within Canada. A total of 80 people with aphasia will be recruited to participate in a two-arm, waitlist-controlled, crossover group RCT. After baseline assessment, participants will be randomized into an intervention group or a waitlist control group. The intervention group participants will engage in 5 weeks of training with the app, followed by posttreatment and follow-up assessments after an additional 5 weeks. Those in the waitlist control group will have no training for 5 weeks; this is followed by pretreatment assessment, training for 5 weeks, and posttreatment assessment. All trial procedures are being conducted remotely given the COVID-19 pandemic. Results: Recruitment of participants started in September 2020, and the study is expected to be completed by March 2022. Publication of results is expected within 6 months of study completion. Conclusions: The results of the RCT will provide information on evidence-based practice using technology-based solutions to treat aphasia. If positive results are obtained from this RCT, the VoiceAdapt app can be recommended as an efficacious means of improving lexical retrieval and communicative functioning in people with aphasia in an easily accessible and a cost-effective manner. Moreover, the implementation of this RCT through remote assessment and delivery can provide information to therapists on telerehabilitation practices and monitoring of app-based home therapy programs. Trial Registration: ClinicalTrials.gov NCT04108364; https://clinicaltrials.gov/ct2/show/NCT04108364 International Registered Report Identifier (IRRID): DERR1-10.2196/30621
AI snapshot
Written from the paper’s full text.
TL;DR
This is a protocol for a two-arm, waitlist-controlled, crossover randomized controlled trial testing VoiceAdapt, a user-centered, tablet-based app that delivers Semantic Feature Analysis and Phonological Components Analysis to improve naming in people with aphasia. The trial is being conducted remotely at two Canadian sites, with results not yet reported.
Key findings
- No efficacy results are reported; the paper describes a planned multicenter RCT of 80 people with aphasia (40 at each of two Canadian sites), with sample size based on medium effect sizes and a ~10% dropout rate (79 required).
- The intervention is 5 weeks of weekday app practice for 1 hour per day (described in the Discussion as 25 hours of training), with primary outcome the Boston Naming Test and secondary outcomes the WAB-R, SAQOL-39, and CETI, plus SUS, SIMS, and an app-usage questionnaire.
- VoiceAdapt instantiates two evidence-based lexical retrieval treatments (PCA and SFA) and was developed with 75 end users (people with aphasia, clinicians, caregivers) across three iterative user-centered design cycles.
- Recruitment started September 2020; primary completion expected March 2022, with publication expected within 6 months of completion.
Methods
- Design: two-arm, randomized, waitlist-controlled, crossover group RCT; Phase 1 intervention vs waitlist control, Phase 2 crossover; randomization via computer-generated list; total participation ~13 weeks with assessments at Weeks 1, 7, and 13.
- Participants: recruited from community aphasia centers, clinics, and research databases in Toronto, Ontario and Edmonton, Alberta; inclusion requires ≥6 months post left-hemisphere stroke, mild-to-moderate aphasia (WAB-R Aphasia Quotient ≥30), <75% correct on the BNT, prominent verbal expression impairment, passing vision/hearing/cognition screens, English as primary language; exclusion for current individual speech-language therapy or use of speech-language therapy apps.
- Analysis: mixed-effects regression for the 2 × 2 crossover with one baseline, with covariate adjustments (site, sex, age, hours of training, assessors, caregiver characteristics), intention-to-treat, Mauchly test for sphericity, and interim analyses at 20, 40, and 60 participants; all procedures conducted remotely due to COVID-19.
Limitations
- The paper states no results yet, so no conclusions about efficacy can be drawn; it is a protocol only.
- Stated: the trial was adapted for remote delivery during the COVID-19 pandemic, with all assessment instruments adapted for remote administration (screen sharing, verbal responses, or annotation).
- Evident from the text: the waitlist-controlled crossover design may be subject to carryover effects, which the authors acknowledge by planning to estimate treatment effects after excluding Period 2 assessments affected by carryover; the sample is limited to English-speaking, chronic, mild-to-moderate aphasia patients, and the app requires tablet access and self-managed home practice.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 33 cited sources checked · 0 supported · 0 flagged
- Premisecitation
Greater intensity of rehabilitation is associated with greater long-term recovery.
“Such apps have the potential to increase the intensity of rehabilitation, a factor that is associated with greater long-term recovery [10-12].”
Quote in the paperSubstantial claim0 of 3 sources checked - Premisecitation
Rehabilitation for people with aphasia provided by speech-language pathologists has shown improved outcomes.
“Rehabilitation for people with aphasia provided by speech-language pathologists (SLPs) has shown improved outcomes [6,7].”
Quote in the paperSubstantial claim0 of 2 sources checked - Premisecitation
In a recent review, only three apps were identified where developers engaged people with aphasia in the design process.
“In a recent review, only three apps were identified where developers engaged people with aphasia in the design process [22].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] Griffel, J, 2019, Aphasie und verwandte Gebiete
Not checked in the free run.
- Premisecitation
Very few therapy apps designed for aphasia have been designed with inputs from relevant stakeholders following the principles of user-centered design.
“Despite the increasing availability of therapy apps designed for aphasia [20], very few have been designed with inputs from relevant stakeholders following the principles of user-centered design (UCD).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] Griffel, J, 2019, Aphasie und verwandte Gebiete
Not checked in the free run.
- Premisecitation
The VoiceAdapt app instantiates Phonological Components Analysis and Semantic Feature Analysis into an adaptive, voice-responsive therapy app.
“Using evidence-based lexical retrieval protocols, the VoiceAdapt app instantiates Phonological Components Analysis (PCA) [23] and Semantic Feature Analysis (SFA) [24] into an adaptive, voice-responsive therapy app that people with aphasia can use to improve their naming skills.”
Quote in the paperSubstantial claim0 of 2 sources checked
- Premisecitation
There was no evidence of patients being involved in either of the two initial phases of app development, theory-based conception and software implementation.
“There was no evidence of patients being involved in either of the two initial phases of app development (ie, theory-based conception, software implementation).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] Griffel, J, 2019, Aphasie und verwandte Gebiete
Not checked in the free run.
- Premisecitation
Mobile app-based therapies can increase the intensity of treatment or rehabilitation.
“These apps can increase the intensity of treatment and have resulted in meaningful outcomes across several domains.”
- Also stated in: § Background · hedged
“Such apps have the potential to increase the intensity of rehabilitation, a factor that is associated with greater long-term recovery [10-12].”
Quote in the paperSubstantial claim0 of 3 sources checked - Also stated in: § Background · hedged
- Premisecitation
Participants in case series and small group studies have shown improvements across a variety of outcome measures, including naming of trained and untrained items, standardized language and cognitive assessment batteries, and spoken discourse.
“Participants in these studies have shown improvements across a variety of outcome measures, including naming of trained and untrained items, standardized language and cognitive assessment batteries, and spoken discourse [15,17-19].”
Quote in the paperSubstantial claim0 of 4 sources checked - Premisecitation
Mobile app-based therapies have resulted in meaningful outcomes across several domains.
“These apps can increase the intensity of treatment and have resulted in meaningful outcomes across several domains.”
- Also stated in: § Background · plain
“SLPs have been increasingly employing such apps as adjuncts or substitutes for traditional (in-person) therapy approaches, with meaningful outcomes observed across several domains [8,9].”
Quote in the paperSubstantial claim0 of 2 sources checked - Also stated in: § Background · plain
- Premisecitation
Additional evidence from case series and small group studies proves the utility of app-based therapy for adults with aphasia in the chronic stages.
“Additional evidence derived from case series and small group studies also proves the utility of app-based therapy for adults with aphasia in the chronic stages.”
Quote in the paperNot a substantial claim0 of 4 sources checked - Study design and conductown data
The sample size calculation is based on medium effect sizes estimated according to previous results.
“The sample size calculation is based on the medium effect sizes estimated in our study according to previous results.”
Quote in the paperSubstantial claim - Premisecitation
Mobile app-based therapies are increasingly employed by speech-language pathologists in the rehabilitation of people with aphasia as adjuncts or substitutes for traditional in-person therapy approaches.
“Mobile app–based therapies are increasingly being employed by speech-language pathologists in the rehabilitation of people with aphasia as adjuncts or substitutes for traditional in-person therapy approaches.”
- Also stated in: § Background · plain
“SLPs have been increasingly employing such apps as adjuncts or substitutes for traditional (in-person) therapy approaches, with meaningful outcomes observed across several domains [8,9].”
Quote in the paperSubstantial claim0 of 2 sources checked - Also stated in: § Background · plain
- Premisecitation
In an RCT of 32 people with aphasia, the treatment group practicing with a tablet-based therapy app demonstrated greater language outcomes than a group completing worksheet exercises.
“In a more recent RCT conducted on 32 people with aphasia, Braley and colleagues [13] reported that people with aphasia in the treatment group who practiced a variety of speech, language, and cognition exercises using a tablet-based therapy app (ie, Constant Therapy) demonstrated greater language outcomes than a group who completed worksheet exercises.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [13] source
Not checked in the free run.
- Premisecitation
Therapy apps do not engage people with aphasia in the development and testing stages.
“Although an increasing number of therapy apps are entering the market, they do not engage people with aphasia in the development and testing stages [22].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] Griffel, J, 2019, Aphasie und verwandte Gebiete
Not checked in the free run.
- Interpretationreasoning
The VoiceAdapt app differs from other apps currently available on the market in that it incorporates evidence-based treatment approaches within a framework identified by end users through a user-centered design process.
“The VoiceAdapt app differs from other apps currently available on the market in that it incorporates evidence-based treatment approaches within a framework that was identified by the end users through a UCD process in the conceptualization, development, and implementation stages of the app.”
Quote in the paperSubstantial claim
- May combine two claims. 4
- Classified as probably not a substantial claim. 9
- The quote only partly states this claim. 1
May combine two claims.
Study design and conductreasoningAccounting for a dropout rate of approximately 10%, 79 people with aphasia are needed; thus, 80 people with aphasia are planned to be enrolled.
“Accounting for a dropout rate of approximately 10%, we need to include 79 people with aphasia; thus, we plan to enroll 80 people with aphasia.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductnone givenAll assessment instruments have been adapted for remote delivery and will be administered by assessors through screen sharing and verbal or pointing responses.
“All assessment instruments have been adapted for remote delivery and will be administered by the assessors through sharing their screen and eliciting verbal responses or pointing to responses using annotation functions within the software.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
PremisecitationMobile tablet-based rehabilitation is feasible for delivering speech-language therapy in an acute care setting.
“Mallet and colleagues [16] demonstrated that mobile tablet–based rehabilitation is feasible for delivering speech-language therapy in an acute care setting.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [16] source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductreasoningAll data collection activities will be conducted virtually using HREU- and HREB-approved video conferencing software.
“With in-person research activities limited due to the COVID-19 pandemic, all data collection activities will be conducted virtually using HREU- and HREB-approved video conferencing software.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenAn intention to treat analysis will be conducted including all randomized participants.
“We will conduct an intention to treat analysis and include all the randomized participants in our analyses.”
Quote in the paperNot a substantial claimThe quote only partly states this claim.
Study design and conductown dataThe VoiceAdapt project has involved 75 end users in the user-centered design process over three iterative cycles.
“The VoiceAdapt project has so far involved 75 end users (people with aphasia, clinicians, and caregivers) in the UCD process to identify the main barriers and obstacles to app-based training and rehabilitation; ensure independent usage and sustained motivation; and optimize the end-user experience and training impact.”
- Also stated in: § VoiceAdapt · plain
“This was achieved by eliciting user requirements (conducting guideline-based structured interviews), designing solutions (mock-ups, prototypes), and evaluating the designs against the requirements (focusing on user experience in terms of multimodal speech interaction and adaptivity) over three iterative cycles.”
Quote in the paperNot a substantial claim- Also stated in: § VoiceAdapt · plain
May combine two claims.
PremisecitationPeople with aphasia can self-deliver app-based intervention and attain positive language and communication outcomes.
“Moreover, recent evidence has shown that people with aphasia can self-deliver this type of intervention and attain positive language and communication outcomes [13-15].”
Quote in the paperSubstantial claim0 of 3 sources checkedClassified as probably not a substantial claim.
PremisecitationAll three apps engaged patients to varying extents during therapy evaluation or prototype testing.
“All these apps engaged patients to varying extents during therapy evaluation or prototype testing.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] Griffel, J, 2019, Aphasie und verwandte Gebiete
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductnone givenParticipants will be randomized to groups according to a computer-generated randomization list.
“Participants will be randomized to groups according to a computer-generated randomization list.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationAn RCT of a tablet-based therapy app for aphasia was conducted virtually with participants self-managing their participation through periodic monitoring by researchers.
“Importantly, this RCT was conducted virtually with participants self-managing their participation through periodic monitoring by the researchers.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [13] source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe study will be conducted according to Canadian and international standards of Good Clinical Practice.
“This study will be conducted according to Canadian and international standards of Good Clinical Practice for all studies.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThe analysis will include covariate adjustments for recruitment site and participant characteristics.
“The analysis will include covariate adjustments for variables such as the recruitment site and participant characteristics (eg, sex, age, hours of training, assessors, and caregiver characteristics).”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductnone givenAll adaptations to the research protocol for remote delivery have been approved by the Research Ethics Boards of the University of Toronto and University of Alberta.
“All adaptations to the research protocol for remote delivery have been approved by the Research Ethics Boards of the University of Toronto and University of Alberta.”
Quote in the paperSubstantial claim
The paper relies on this without support.
Constraints on health care resources often prevent people with aphasia from receiving services, particularly in the chronic stages.
“However, several factors, including constraints on health care resources, often prevent people with aphasia from receiving services, particularly in the chronic stages.”
The paper relies on this without support.
Large-scale randomized controlled trials investigating the clinical utility of tablet-based speech-language therapy apps for aphasia have not been conducted.
“Large-scale randomized controlled trials (RCTs) investigating the clinical utility of tablet-based speech-language therapy apps for aphasia have not been conducted.”
The paper relies on this without support.
Mobile app-based therapies provide a cost-effective means by which people with aphasia can receive prolonged rehabilitation.
“The recent proliferation of mobile app–based therapies (apps) has provided a cost-effective means by which people with aphasia can receive prolonged rehabilitation.”
The paper relies on this without support.
Technology-based solutions can increase home practice and therapy intensity in a cost-effective manner.
“Technology-based solutions, including apps to reach speech-language therapy and communication goals can be a means to increase home practice and therapy intensity in a cost-effective manner.”
The paper relies on this without support.
For people with aphasia in the chronic stages of recovery, there can be limited rehabilitation options.
“Particularly for people with aphasia who are in the chronic stages of recovery (ie, more than a year post the onset of aphasia), there can be limited rehabilitation options.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Planned enrollment for the study was 80 participants based on sample size calculations.
“Planned enrollment for the study was 80 participants based on sample size calculations, with interim analyses planned when quarterly enrollment targets were met (ie, 20, 40, and 60 participants) [39].”
From Outcomes of an App-Based Intervention to Target Naming Among Individuals With Poststroke Aphasia: Virtual Randomized Controlled Trial (2025) · cites this paper as [39]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
BNT and WAB-R citations are reversed in the eligibility criteria
MinorThe eligibility criteria cite [25] for the WAB-R and [26] for the BNT, while the Measures section assigns [25] to the BNT and [26] to the WAB-R. The reference list confirms the latter assignments.
“have mild-to-moderate aphasia (Aphasia Quotient ≥30 on the Western Aphasia Battery-Revised [WAB-R]) [25]; score below 75% correct on the Boston Naming Test (BNT) [26] during initial assessment”
“The primary outcome measure will be the BNT [25] to measure naming; secondary outcome measures will be the WAB-R [26]”
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Cited by
Sorted by citations
Kim, E. S., Laird, L., Wilson, C., Stewart, S., Mildner, P., Möller, S., Schatz, R., Spang, R. P., Voigt-Antons, J.-N., & Rochon, E. (2025) · JMIR mHealth and uHealth · doi:10.2196/67711 · Cited by 2 · see citing works
“Assessors at both sites completed all steps in the training protocol including reading background papers [39,40], reviewing intake and consent forms and manuals for all assessments, observing the study coordinator or primary investigators (licensed SLPs) doing a complete assessment session, and…”
Self-citation
- Authors
- Kim, E. S., Laird, L., Wilson, C., Bieg, T., Mildner, P., Möller, S., Schatz, R., Schwarz, S., Spang, R., Voigt-Antons, J.-N., & Rochon, E.
- Affiliations
- University of Alberta (CA)
- University Health Network (CA)
- AIT Austrian Institute of Technology GmbH (AT)
- German Research Centre for Artificial Intelligence (DE)
- Technische Universität Berlin (DE)
- Corresponding author
- Kim, Esther S
- ORCID
- Venue
- JMIR Research Protocols
- Publisher
- JMIR Publications Inc.
- Published
- 2021-07-02
- Volume
- 10
- Issue
- 7
- Pages
- e30621
- ISSN
- 1929-0748 (ISSN-L)
- PMC
- PMC8285741
- OpenAlex
- W3165727267
- Semantic Scholar
- 18d38686c91f162e9f910bdf81952cd6f2ae6a6c
- Cited by
- 12
- References
- 31
- Citations by year
- 2025: 4 · 2024: 3 · 2023: 2 · 2022: 2 · 2021: 1
- FWCI
- 3.29
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- JMIR Research Protocols (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Health Sciences › Health Professions › Occupational Therapy › Assistive Technology in Communication and Mobility
- Life Sciences › Neuroscience › Cognitive Neuroscience › Neurobiology of Language and Bilingualism
- Health Sciences › Medicine › Rehabilitation › Stroke Rehabilitation and Recovery
- Keywords
- aphasia, stroke, word retrieval, naming, speech therapy, telepractice, telerehabilitation, user-centered design, remote intervention, home-based therapy, communication outcomes
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