Sentence therapy for post-stroke aphasia: UTILISE telerehabilitation
| ISRCTN | ISRCTN11888024 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11888024 |
| Secondary identifying numbers | LCD-2022-18 v1 |
- Submission date
- 05/07/2023
- Registration date
- 07/07/2023
- Last edited
- 19/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
One consequence of a stroke can be aphasia – difficulty understanding and producing language. The condition can result in significant limitations in taking part in conversations with family and friends, engaging in employment and using spoken and written language to access media. It has profound effects on well-being and quality of life. Aphasia typically impairs both vocabulary and grammar, and there has been considerable advance in the management of lexical impairments. However, there has been less progress in therapies for sentence processing. This is a problem as everyday interactions involve listening to and using sentences. We apply a usage-based approach to sentence processing impairments in aphasia. This approach involves a focus on high-frequency phrases and sentences that are used in everyday conversations.
The researchers will examine the outcomes in sentence understanding and production of a telerehabilitation model of therapy delivery. Participants self-deliver the intervention via an app with remote monitoring by a researcher/clinician. The user can administer the therapy at convenient times and locations with the aim that overcoming barriers to accessing therapy will result in high-intensity rehabilitation. The intervention – called UTILISE - stimulates sentence understanding and production of high-frequency sentences in two listening tasks, and one production task. The app also includes automatic speech recognition so that users gain rapid and precise feedback on their speech attempts. In addition to stimulation of the core sentences, new vocabulary items are introduced into the phrases in order to increase the flexibility and creativity of speech.
The researchers measure the participants' language abilities twice before therapy starts to discover if their behaviour is stable before intervention. All participants are then loaned an iPad loaded with the app. They will access the app for 4 weeks. The researchers then re-measure language abilities immediately after the therapy period and again after an 8-week period to determine the longer-term effects of the therapy. Some participants will be asked to have an MRI brain scan if this procedure is suitable for them, but this is an optional part of the study.
Who can participate?
Adults with aphasia who have had a stroke at least 4 months ago. Participants must previously be competent in speaking English and use English frequently at home. Participants must have sufficient visual and auditory acuity to interact with the app.
What does the study involve?
Participants travel to University College London to complete two baseline sessions. In these sessions, language ability, cognitive skills and self-reported perceptions of life after stroke are measured, and samples of speech are recorded. After the second session, the participant is loaned an iPad on which the UTILISE app is installed and shown how to use the iPad and app. Participants are encouraged to use the app at home for 4 weeks with remote monitoring and support from the research team. After the intervention, participants return to University College London and the effects of the treatment are measured. There is also the opportunity for the person with aphasia to give feedback on the app in a semi-structured interview. Family members can also take part in semi-structured interviews to discuss their experience of telerehabilitation. Behaviour is measured again 8 weeks later to discover if any changes are maintained once the therapy stops. Participants with aphasia have the option to take part in a focus group to discuss their experience of telerehabilitation.
What are the possible benefits and risks of participating?
The possible benefits of participating are that individuals access the UTILISE sentence therapy app for 4 weeks of self-directed intensive therapy with remote support from the research team. This may lead to improved sentence understanding and production. There are no known side effects associated with computer therapy. However, participants might not benefit from this therapy and find the tasks frustrating.
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
October 2022 to September 2025
Who is funding the study?
The Stroke Association (UK)
Who is the main contact?
Prof. Rosemary Varley, rosemary.varley@ucl.ac.uk
Contact information
Principal Investigator
Language & Cognition
Psychology & Language Sciences
Chandler House
2 Wakefield Street
London
WC1N 1PF
United Kingdom
 ORCID ID |
0000-0002-1278-0601 |
|---|---|
| Phone | +44 (0)20 7679 4234 |
| rosemary.varley@ucl.ac.uk |
Study information
| Study design | Single centre interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Study type | Participant information sheet |
| Scientific title | UTILISE-2: a telerehabilitation app for sentence difficulties in post-stroke aphasia |
| Study acronym | UTILISE-2 |
| Study hypothesis | 1. Does the UTILISE-2 therapy app improve connected speech production and spoken sentence comprehension in comparison to waitlist/usual care control? 2. Are any therapy effects maintained over an 8-week no-treatment period? 3. What is the impact of the intervention on an aphasia severity score? 4. What is the impact of the intervention on perceptions of quality of life? 5. What is the relationship between self-delivered dose and treatment outcomes? 6. How acceptable is the telehealth model of UTILISE therapy to people with aphasia and their family members? |
| Ethics approval(s) |
Approved 03/01/2023, UCL Psychology & Language Sciences (Language & Cognition) (Chandler House, 2 Wakefield Street, London, WC1N 1PF, United Kingdom; +44 (0)20 7679 8692; f.kyle@ucl.ac.uk), ref: LCD-2022-18 |
| Condition | Sentence processing impairments in post-stroke aphasia |
| Intervention | After first baseline assessment, participants are randomised with a 1:1 ratio to Immediate or Deferred treatment conditions. Randomisation is stratified by sex and 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. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/10/2022 |
| Overall study end date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient, Carer, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 50 |
| Participant 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 |
| Participant exclusion criteria | 1. Significant other neurological disorder (e.g. neurodegenerative illness) 2. History of speech and language disorder prior to stroke (e.g. developmental language disorder) 3. Concurrent involvement in another therapy study 4. Previous involvement in the UTILISE-1 therapy study 5. Severe apraxia of speech: unable to repeat high-frequency single words and short sentences |
| Recruitment start date | 10/07/2023 |
| Recruitment end date | 04/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Chandler House
2 Wakefield Street
London
WC1N 1PF
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)20 7679 2000 |
|---|---|
| h.dougal@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Multi-level dissemination is planned, including people with aphasia and their family members, clinicians and the academic community. Publication is planned in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during the current study will be available upon reasonable request from Rosemary Varley (rosemary.varley@ucl.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 07/07/2023 | No | Yes | ||
| Protocol (other) | 15/08/2023 | 12/09/2023 | No | No |
Editorial Notes
19/12/2024: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The recruitment end date was changed from 31/01/2025 to 04/12/2024.
12/09/2023: Protocol added.
07/07/2023: Study's existence confirmed by the Stroke Association.
