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Category: Project

Description: Background: This study builds on the project Reconstructing Sentence Processing in Aphasia (https://osf.io/fduqh/; https://www.isrctn.com/ISRCTN14466044). In this previous project, which we now label as UTILISE-1, we explored outcomes of a therapy for post-stroke sentence processing impairments informed by a usage-based Construction Grammar approach (CxG, Diessel, 2015). The therapy – UTILISE (Unification Therapy Integrating LexIcon and Sentences) – targets spoken sentence comprehension and production. At the core of the intervention are sentences of high usage frequency. In the UTILISE-1 study, intervention was delivered in a research lab/clinic and at low dose. Participants with aphasia attended for 12 one-hour sessions over a four-week period. Initial outcomes were promising, particularly with regard to sentence production. In this new UTILISE-2 study, the UTILISE intervention has been converted into a digital therapy app that can be used in remote telerehabilitation. The user can self-administer the intervention, with remote monitoring by the researcher/clinician. The app records all interactions with the therapy, including progression and usage. The app-delivered intervention has the potential for therapy at sufficient dose/intensity to stimulate improvement in language processing. The aims of the study are: (1) To determine if the UTILISE app for aphasic sentence processing impairment is more effective than usual care in improving sentence production and comprehension, and overall aphasia severity. (2) To determine whether any therapy effects are evident after an 8-week maintenance period. (3) To determine whether there is a relationship between the self-delivered treatment dose/intensity and outcomes. Methods: UTILISE-2 is an exploratory pilot trial with a waitlist control design. The trial aims to recruit 50 participants. Following the first baseline evaluation, participants are randomised to either Immediate or Deferred trial entry conditions. For participants in the Immediate condition, a second baseline measure is taken after four weeks and they then access the therapy for four weeks via a loaned iPad. For those in the Deferred condition, the second baseline is taken after eight weeks, and then they too access four weeks of therapy. This design permits a between-group treatment/usual care comparison. Baseline evaluations include profiling of language and related cognitive functions, aphasia severity with The Quick Aphasia Battery (QAB; Wilson, Eriksson, Schneck, & Lucanie, 2018), and the study-specific outcome measures. The intervention is delivered via an iPad with the UTILISE sentence therapy app installed. Participants are trained to use the iPad and app, and encouraged to engage in the therapy in short, frequent sessions. During the intervention period, the researcher remotely monitors interactions with the app and responds to participant requests via an in-app “help” function. There will also be a regular programme of support calls from the researcher. Outcomes are measured immediately post-therapy and after an eight-week no-treatment period. There are two primary outcome measures: (1) degree of connectivity of spontaneous speech, and (2) spoken sentence comprehension. Degree of connectivity is the ratio of three-word combinations to total number of words in personal narratives and narration of a picture cartoon series. Speech samples will be audio-recorded. These samples will be transcribed and tagged by raters who are blind to allocation and phase. Analysis will be performed using an automated analysis software (Frequency in Language Analysis Tool, FLAT; Zimmerer, Newman, Thomson, Coleman, & Varley, 2018). Spoken sentence comprehension is measured via the Test of Reception of Grammar (TROG-2; Bishop, 2003). Secondary outcome measures include a study-specific story completion test (adapted from Goodglass, Gleason, Ackerman, Bernholtz, & Hyde, 1972) of production of treated and untreated phrases. Further secondary outcome measures are of overall aphasia severity using the QAB (Wilson et al., 2018), alongside a self-report of communication effectiveness and quality of life: the Communication Outcome After Stroke (COAST) scale (Long, Hesketh, Paszek, Booth, & Bowen, 2008). The efficacy of the UTILISE digital sentence therapy app will be evaluated through within-group comparison of performance across time and between-group comparison of scores of the Immediate and Deferred entry groups. Furthermore, maintenance of any behavioural gains will be determined by measure of change between the initial outcome and the follow-up maintenance assessment. Discussion: The acceptability of the intervention will be established via rates of retention and analysis of participant and family member feedback from semi-structured interviews and focus groups. In a series of planned comparisons, we will first determine the stability of sentence processing behaviours between the two baseline sessions, and assess change to probed behaviours following intervention. Associations between baseline profiles, app usage and outcomes will be explored via regression analysis. Participant responses in semi-structured interviews and focus groups will additionally illuminate the factors that drive self-delivered dose. Full protocol available: https://osf.io/zbpqv