Sentence therapy for post-stroke aphasia: UTILISE telerehabilitation

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: After first baseline assessment, participants are randomised with a 1:1 ratio to Immediate or Deferred treatment conditions. Randomisation is stratified by se Xand employs block randomisation. Researchers are blind to block size. Participants in the Immediate condition complete a second baseline assessment 4 weeks later and then immediately start the intervention. Participants in the Deferred condition complete a second baseline assessment at 8 weeks after the first baseline and act as a waitlist/usual care control. They then enter the intervention phase. The intervention (UTILISE‐2) consists of an app‐based behavioural intervention available to participants on a loaned iPad for a 4‐week period. The computerised intervention comprises three tasks: Task 1: attention to auditory sentence stimuli; Task 2: an auditory word monitoring paradigm; Task 3: sentence production with a gradual increase in sentence length and creativity with feedback given using automatic speech recognition. All stimuli include high‐frequency phrase/sentence frames. The treatment is self‐delivered by participants at home for the 4‐week intervention period. The research team will monitor interaction with the app and offer remote support should a participant alert them via the in‐app ‘help’ facility. Participants are encouraged to engage with the app for at least 1 hour per day (ideally in short 20‐30 minute blocks). The app records engagement so that therapy dose/intensity can be tracked. For both study arms, outcomes are measured at the end of the treatment phase and again after an 8‐week no‐treatment/maintenance period. CONDITION: Sentence processing impairments in post‐stroke aphasia ; Mental and Behavioural Disorders PRIMARY OUTCOME: 1. Sentence comprehension measured using a count for total items correct on the Test for Reception of Grammar (TROG‐2) at two baseline timepoints and two outcome timepoints; 2. Fluency and connectivity of speech measured in narrative samples by automated language analysis (FLAT) via combination ratio (number of three‐word combinations/total number of words) at two baseline timepoints and two outcome timepoints; SECONDARY OUTCOME: 1. Retrieval and grammaticality of treated and matched control sentences measured using a study‐specific story completion test at Baseline 2 and immediately after the intervention; 2. Quality of life measured by score on the Communication Outcomes After Stroke at Baseline 1 and immediately post‐treatment; 3. Sentence production in narrative speech profiled with other FLAT variables (mean length of utterance, function word ratio and frequency of words and their combinations) at two baseline timepoints and two outcome timepoints; 4. Overall aphasia severity measured by scores on the Quick Aphasia Battery at second baseline and immediate and maintenance outcome timepoints INCLUSION CRITERIA: 1. Aged over 18 years 2. Pre‐morbid competence in English and frequent use of English post‐stroke 3. Pre‐morbidly right‐handed with left‐sided stroke; or pre‐morbidly left‐handed with right‐sided stroke 4. At least 4 months post‐onset of stroke which resulted in aphasia 5. Presence of moderate to severe aphasia, characterised by spoken sentence comprehension impairment (scoring <16 blocks correct on TROG‐2) and/or spoken sentence production difficulties (incomplete and/or simple sentences) at baseline assessment 6. Capacity to give informed consent 7. Sufficient auditory and visual capacity to interact with the therapy app
Epistemonikos ID: b5c1692f5faad586a04a2276238479a35c37d2c5
First added on: Aug 26, 2024