AphasiaPhase 1LUNANCT05847023
Proof-of-concept Study of LUNA Intervention in Aphasia
A Phase 1 study testing LUNA in people with Aphasia and Stroke, run by City, University of London at 1 site in United Kingdom.
Trial summary
Existing evidence-based treatments for word-level and sentence-level impairments following aphasia typically do not generalise to gains in everyday communication for people with aphasia (after stroke). Novel treatments need to be developed to address this. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- LUNA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2020to 28 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of ischaemic or haemorrhagic stroke
- have aphasia due to a stroke that occurred at least 12 months prior to recruitment
- literate and fluent users of English prior to their stroke (self-reported)
- have adequate hearing and vision with aids and glasses, e.g. in order to see pictorial and written assessment and therapy materials
- must have access to a computer or tablet and an internet connection
- must be able to download and access Zoom, either independently or with the support of a friend/family member who is living with them
Who cannot join
- must not be receiving speech and language therapy elsewhere for the duration of the study. Usual stroke supports, for example provided by the voluntary sector, can proceed, although these are likely to be curtailed owing to COVID-19
- must not be participating in any other aphasia treatment research project for the duration of the study
- must not have severe aphasia, defined as a score of 7 or less on the Frenchay Aphasia Screening Test (FAST: Enderby et al., 1986; unlikely to benefit from treatment)
- must not have a secondary cognitive diagnosis such as dementia. This will be established via self-report and the confirmation of the group co-ordinator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Language and Communication Science, City, University of London
London
About this study
Official title: Linguistic Underpinnings of Narrative in Aphasia (LUNA): A Proof-of-concept Study of a Novel Discourse Treatment for Aphasia Using Personal Narratives
Existing evidence-based treatments for word-level and sentence-level impairments following aphasia typically do not generalise to gains in everyday communication for people with aphasia (after stroke). Novel treatments need to be developed to address this. LUNA is a novel multi-level discourse treatment for people with mild to moderate aphasia that addresses personal narratives in a personalised and meta-linguistic and metacognitive manner. This is a feasibility randomised waitlist controlled trial of LUNA, in 28 people with post-stroke chronic aphasia. It will test feasibility, acceptability, preliminary efficacy, and treatment fidelity. Findings will enable the investigators to judge whether there is merit in proceeding to a larger definitive trial.
Read the detailed description
One third of stroke survivors have aphasia (a language impairment) which negatively affects communication, relationships, work, socialising, and wellbeing. Speech and language therapy is effective at improving language outcomes for people with aphasia (PWA) but gains in saying words and sentences rarely translate into gains in everyday talking (discourse). Most evidence generated over the last 40 years does not consider how words, sentences and everyday talk are linked together. Recent research signals new approaches are needed targeting multiple levels of language within the same treatment, and treatment needs to explicitly target everyday talking. Research conducted with stakeholders confirms new discourse treatments are a priority to clinicians and researchers, and improved everyday talking is prioritised by PWA as an outcome from rehabilitation.
The proposed research addresses the gap in the evidence base for a theoretically-underpinned multilevel discourse treatment for PWA. The project is titled LUNA and stands for Linguistic Underpinnings of Narrative in Aphasia. It focusses on personal narratives, that is, the short stories people tell others e.g. about recent holiday, funniest memory from school/ work, memorable life moments, etc. Personal stories are central to everyday talking; are important in health, recovery and adjustment; and are commonly used in clinical practice i.e. 70% of speech and language therapists (SLTs) the investigators surveyed in the United Kingdom ask patients to tell personal stories during rehabilitation. LUNA draws on existing word and sentence level treatments that are known to be effective in improving language. The discourse literature is less developed, but describes strategies that similarly feature in LUNA treatment (e.g. telling the key elements of a story and doing so in the correct order so the listener understands). LUNA integrates these and works directly with the participant to improve their own stories. Choosing personalised vocabulary (i.e. the person's own words) increases motivation. Finally, LUNA teaches the person about their language, so they understand their difficulties, thereby empowering them to make connections from clinic to their real life use of talking.
In response to the COVID 19 crisis the investigators plan to conduct all data collection remotely, via video conferencing technology. There is growing evidence that telehealth can be employed successfully in aphasia rehabilitation. Remote administration of aphasia assessment has been shown to be valid, reliable and acceptable to people with aphasia. While not extensively tested, remote therapy has also proved feasible and has produced outcomes that are similar to those achieved by face to face delivery. This study aims to add to the evidence for aphasia tele-rehabilitation by testing the first application of remote discourse therapy.
Aims:
This study will test feasibility of LUNA in terms of participant recruitment and retention, and adherence throughout the study (assessment and treatment sessions). It will explore participant acceptability of LUNA and project procedures (satisfaction, perceived benefits, assessment and treatment burden) in semi-structured individual interviews with participants.
It will investigate initial efficacy by comparing outcomes on a range of measures across participants who have and have not received LUNA intervention. It will assess treatment fidelity by reviewing a sample of videotaped sessions to check they were delivered as intended by the treatment manual. The study will also test the feasibility and acceptability of remote assessment and treatment delivery. For example, recruitment, retention and compliance data will attempt to identify losses due to technological factors; and interview questions will explicitly probe the experience of using video-conferencing technology.
Indicative outcome data will be for remote (not face-to-face) LUNA.
Design:
The study is a single-blind, waitlist, randomised controlled trial of LUNA for people with chronic post-stroke aphasia. Participants will complete assessments at three time points: T1 (weeks 1\&2), T2 (weeks 13 \& 14) and T3 (weeks 25 \& 26). Following T1, participants will be randomised to an immediate or delayed condition. Those in the immediate condition will receive LUNA therapy between T1 and T2. Those in the delayed condition will receive LUNA therapy between T2 and T3. All participants will be invited to participate in in-depth individual semi-structured interviews post-therapy to explore their experiences of taking part in the study.
In line with selection criteria, participants will not be receiving any other speech and language therapy during the study. Owing to COVID 19, it is anticipated that most participants will not have access to usual care (attendance at stroke groups). Some may access on-line supports, for example provided by Aphasia Re-Connect. Use of such services is not an exclusion criterion. Use of other services will be explored in the interviews.
- Being tested
- LUNA
- Keywords
- Treatment, Feasibility study, Discourse
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUNABehavioural
see description above
| Study group | Role | What they receive |
|---|---|---|
| Immediate LUNA intervention | Experimental | LUNA intervention between T1 and T2. No treatment between T2 and T3. LUNA intervention comprises 20hrs of face-to-face treatment, 2 sessions per week of 60 minutes each, for 10 weeks. One session is delivered by a qualified speech and language therapist; the other session is delivered by an assistant (student or volunteer) following guidance and under distance supervision. Both therapist and assistant will receive LUNA training. The treatment is specified in the TIDIER checklist. In brief, it aims to improve spoken discourse production, using personal narratives as assessment and treatment stimulate, and by integrating word, sentence and discourse level tasks. Treatment is manualised and has been codesigned with key stakeholders (providers and users). Receives: Behavioral: LUNA |
| Delayed LUNA intervention | Experimental | Wait between T1 and T2. LUNA between T2 and T3. LUNA intervention as above Receives: Behavioral: LUNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal narratives measure (LUNA Discourse Protocol)
Participants will produce two personal narratives at each assessment point, which will be video/audio recorded. They will be given instructions e.g. length of narrative, indication of topic etc. The narrative will be spoken face-to-face to the assessing therapist. S/he will not provide any cues or ask questions. Recording will cease when the participant indicates that the story is finished. Discourse samples will be analysed according to the LUNA Research Discourse Analysis Protocol. The analysis yields the following data: number and %narrative words, and number of narrative words/minute; %Correct Information Units( CIU); number of CIUs/minute; %complete utterances; %single versus multi-clause utterances; #1, 2, and 3 argument utterances; Predicate Argument Score; story grammar count of elements; global coherence score; local coherence score; reference chains count; and overall listener judgment. Number of narrative words is proposed as the primary discourse outcome.
Measured: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Secondary outcomes (5)
The Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Tests speaking, auditory comprehension, naming and repetition across 4 sections. Takes 30-45 minutes. Internationally used language functioning test; also recommended internally as a core outcome measure. Provides information on type of aphasia, and severity.
Measured: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
The Communicative Participation Item Bank (CPIB) - General Short Form [Patient Reported Outcome Measure]
10 items. Items are worded as the degree to which the person's condition interferes with e.g. communicating when out in the community. Designed for adults with communication disorders with substantial input from individuals themselves. Short form recently proven appropriate for people with aphasia (Baylor et al., 2017). We anticipate overlap in item content of the CPIB with the ALA, however, we are intentionally including this instrument as it is possible that this much shorter instrument may be more acceptable (for its brevity) and on post-hoc analysis from the interviews, may align more with participants' perceptions of benefit from the intervention. This will contribute to decision-making for a future large trial. <15 minutes.
Measured: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
The Communication Confidence Rating Scale for Aphasia (CCRSA) [Patient Reported Outcome Measure]
10 items. The only confidence measure in our field. Increasingly used in treatment studies. Takes <10minutes.
Measured: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
The Assessment for Living with Aphasia (ALA) [Patient Reported Outcome Measure]
52 items. Is a pictographic self-report test of aphasia-related quality of life. Created by internationally leading charity in Canada. Increasingly used in treatment studies. Takes up to 45 minutes.
Measured: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Visual Analogue Mood Scales (VAMS) [Patient Reported Outcome Measure]
Following feedback from our advisors with aphasia (and supported by the research team), a single item mood measure, the Visual Analogue Mood Scales (VAMS) Sad scale (Stern et al., 1997) was added to all testing time points. It has been used successfully in aphasia studies (Marshall et al., 2019; Thomas et al., 2013) and takes 3 minutes to complete. It is accessible and appropriate to be used with stroke survivors who have aphasia. Content validity has been established (Nyenhuis et al., 1997; Stern et al., 1997) and test re-test reliability (House et al., 2012).
Measured: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start14 Jun 2020
- Primary completion1 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a single-blind, waitlist, randomised controlled trial of LUNA for people with chronic post-stroke aphasia. Participants will complete assessments at three time points: T1 (weeks 1\&2), T2 (weeks 13 \& 14) and T3 (weeks 25 \& 26). Following T1, participants will be randomised to an immediate or delayed condition. Those in the immediate condition will receive LUNA therapy between T1 and T2. Those in the delayed condition will receive LUNA therapy between T2 and T3. All participants will be invited to participate in in-depth individual semi-structured interviews post-therapy to explore their experiences of taking part in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Cruice, Principal investigator, City, University of LondonProf Dipper, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847023
- Sponsor's protocol ID
- TSA2017/01
- Acronym
- LUNA
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agostini M, Garzon M, Benavides-Varela S, De Pellegrin S, Bencini G, Rossi G, Rosadoni S, Mancuso M, Turolla A, Meneghello F, Tonin P. Telerehabilitation in poststroke anomia. Biomed Res Int. 2014;2014:706909. doi: 10.1155/2014/706909. Epub 2014 Apr 15.
PubMed 24829914Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
PubMed 22592672Cruice, M., Woolf, C., Caute, A., Monnelly, K., Wilson, S. & Marshall, J. (2021) Preliminary outcomes from a pilot study of personalised online supported conversation for participation intervention for people with Aphasia, Aphasiology, 35:10, 1293-1317, DOI: 10.1080/02687038.2020.1795076
Dekhtyar M, Braun EJ, Billot A, Foo L, Kiran S. Videoconference Administration of the Western Aphasia Battery-Revised: Feasibility and Validity. Am J Speech Lang Pathol. 2020 May 8;29(2):673-687. doi: 10.1044/2019_AJSLP-19-00023. Epub 2020 Mar 19.
PubMed 32191122Enderby P, Wood V, Wade D. Frenchay aphasia screening test (FAST). West Sussex: Wiley; 1986.
Guo YE, Togher L, Power E, Hutomo E, Yang YF, Tay A, Yen SC, Koh GC. Assessment of Aphasia Across the International Classification of Functioning, Disability and Health Using an iPad-Based Application. Telemed J E Health. 2017 Apr;23(4):313-326. doi: 10.1089/tmj.2016.0072. Epub 2016 Nov 1.
PubMed 27802112Julious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
Rose M, Ferguson A, Power E, Togher L, Worrall L. Aphasia rehabilitation in Australia: Current practices, challenges and future directions. Int J Speech Lang Pathol. 2014 Apr;16(2):169-80. doi: 10.3109/17549507.2013.794474. Epub 2013 Jun 18.
PubMed 23777446Theodoros D, Hill A, Russell T, Ward E, Wootton R. Assessing acquired language disorders in adults via the Internet. Telemed J E Health. 2008 Aug;14(6):552-9. doi: 10.1089/tmj.2007.0091.
PubMed 18729754Wallace SJ, Worrall L, Rose T, Le Dorze G, Cruice M, Isaksen J, Kong APH, Simmons-Mackie N, Scarinci N, Gauvreau CA. Which outcomes are most important to people with aphasia and their families? an international nominal group technique study framed within the ICF. Disabil Rehabil. 2017 Jul;39(14):1364-1379. doi: 10.1080/09638288.2016.1194899. Epub 2016 Jun 27.
PubMed 27345867J. Webster, A. Whitworth & J. Morris (2015) Is it time to stop "fishing"? A review of generalisation following aphasia intervention, Aphasiology, 29:11, 1240-1264, DOI: 10.1080/02687038.2015.1027169
Weidner, K., & Lowman, J. (2020). Telepractice for adult speech-language pathology services: A systematic review. Perspectives of the ASHA Special Interest Groups, 5(1), 326-338. doi:10.1044/2019_PERSP-19-00146
A. Whitworth, S. Leitão, J. Cartwright, J. Webster, G.J. Hankey, J. Zach, D. Howard & V. Wolz (2015) NARNIA: a new twist to an old tale. A pilot RCT to evaluate a multilevel approach to improving discourse in aphasia, Aphasiology, 29:11, 1345-1382, DOI: 10.1080/02687038.2015.1081143
Woolf C, Caute A, Haigh Z, Galliers J, Wilson S, Kessie A, Hirani S, Hegarty B, Marshall J. A comparison of remote therapy, face to face therapy and an attention control intervention for people with aphasia: a quasi-randomised controlled feasibility study. Clin Rehabil. 2016 Apr;30(4):359-73. doi: 10.1177/0269215515582074. Epub 2015 Apr 24.
PubMed 25911523Cruice M, Botting N, Marshall J, Boyle M, Hersh D, Pritchard M, Dipper L. UK speech and language therapists' views and reported practices of discourse analysis in aphasia rehabilitation. Int J Lang Commun Disord. 2020 May;55(3):417-442. doi: 10.1111/1460-6984.12528. Epub 2020 Feb 24.
PubMed 32090417
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linguistic Underpinnings of Narrative in Aphasia (LUNA): A Proof-of-concept Study of a Novel Discourse Treatment for Aphasia Using Personal Narratives
- ClinicalTrials.gov ID
- NCT05847023
- Acronym / sponsor ID
- LUNA / TSA2017/01
- Keywords
- Treatment, Feasibility study, Discourse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Existing evidence-based treatments for word-level and sentence-level impairments following aphasia typically do not generalise to gains in everyday communication for people with aphasia (after stroke). Novel treatments need to be developed to address this. LUNA is a novel multi-level discourse treatment for people with mild to moderate aphasia that addresses personal narratives in a personalised and meta-linguistic and metacognitive manner. This is a feasibility randomised waitlist controlled trial of LUNA, in 28 people with post-stroke chronic aphasia. It will test feasibility, acceptability, preliminary efficacy, and treatment fidelity. Findings will enable the investigators to judge whether there is merit in proceeding to a larger definitive trial.
Detailed description
One third of stroke survivors have aphasia (a language impairment) which negatively affects communication, relationships, work, socialising, and wellbeing. Speech and language therapy is effective at improving language outcomes for people with aphasia (PWA) but gains in saying words and sentences rarely translate into gains in everyday talking (discourse). Most evidence generated over the last 40 years does not consider how words, sentences and everyday talk are linked together. Recent research signals new approaches are needed targeting multiple levels of language within the same treatment, and treatment needs to explicitly target everyday talking. Research conducted with stakeholders confirms new discourse treatments are a priority to clinicians and researchers, and improved everyday talking is prioritised by PWA as an outcome from rehabilitation.
The proposed research addresses the gap in the evidence base for a theoretically-underpinned multilevel discourse treatment for PWA. The project is titled LUNA and stands for Linguistic Underpinnings of Narrative in Aphasia. It focusses on personal narratives, that is, the short stories people tell others e.g. about recent holiday, funniest memory from school/ work, memorable life moments, etc. Personal stories are central to everyday talking; are important in health, recovery and adjustment; and are commonly used in clinical practice i.e. 70% of speech and language therapists (SLTs) the investigators surveyed in the United Kingdom ask patients to tell personal stories during rehabilitation. LUNA draws on existing word and sentence level treatments that are known to be effective in improving language. The discourse literature is less developed, but describes strategies that similarly feature in LUNA treatment (e.g. telling the key elements of a story and doing so in the correct order so the listener understands). LUNA integrates these and works directly with the participant to improve their own stories. Choosing personalised vocabulary (i.e. the person's own words) increases motivation. Finally, LUNA teaches the person about their language, so they understand their difficulties, thereby empowering them to make connections from clinic to their real life use of talking.
In response to the COVID 19 crisis the investigators plan to conduct all data collection remotely, via video conferencing technology. There is growing evidence that telehealth can be employed successfully in aphasia rehabilitation. Remote administration of aphasia assessment has been shown to be valid, reliable and acceptable to people with aphasia. While not extensively tested, remote therapy has also proved feasible and has produced outcomes that are similar to those achieved by face to face delivery. This study aims to add to the evidence for aphasia tele-rehabilitation by testing the first application of remote discourse therapy.
Aims:
This study will test feasibility of LUNA in terms of participant recruitment and retention, and adherence throughout the study (assessment and treatment sessions). It will explore participant acceptability of LUNA and project procedures (satisfaction, perceived benefits, assessment and treatment burden) in semi-structured individual interviews with participants.
It will investigate initial efficacy by comparing outcomes on a range of measures across participants who have and have not received LUNA intervention. It will assess treatment fidelity by reviewing a sample of videotaped sessions to check they were delivered as intended by the treatment manual. The study will also test the feasibility and acceptability of remote assessment and treatment delivery. For example, recruitment, retention and compliance data will attempt to identify losses due to technological factors; and interview questions will explicitly probe the experience of using video-conferencing technology.
Indicative outcome data will be for remote (not face-to-face) LUNA.
Design:
The study is a single-blind, waitlist, randomised controlled trial of LUNA for people with chronic post-stroke aphasia. Participants will complete assessments at three time points: T1 (weeks 1\&2), T2 (weeks 13 \& 14) and T3 (weeks 25 \& 26). Following T1, participants will be randomised to an immediate or delayed condition. Those in the immediate condition will receive LUNA therapy between T1 and T2. Those in the delayed condition will receive LUNA therapy between T2 and T3. All participants will be invited to participate in in-depth individual semi-structured interviews post-therapy to explore their experiences of taking part in the study.
In line with selection criteria, participants will not be receiving any other speech and language therapy during the study. Owing to COVID 19, it is anticipated that most participants will not have access to usual care (attendance at stroke groups). Some may access on-line supports, for example provided by Aphasia Re-Connect. Use of such services is not an exclusion criterion. Use of other services will be explored in the interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a single-blind, waitlist, randomised controlled trial of LUNA for people with chronic post-stroke aphasia. Participants will complete assessments at three time points: T1 (weeks 1\&2), T2 (weeks 13 \& 14) and T3 (weeks 25 \& 26). Following T1, participants will be randomised to an immediate or delayed condition. Those in the immediate condition will receive LUNA therapy between T1 and T2. Those in the delayed condition will receive LUNA therapy between T2 and T3. All participants will be invited to participate in in-depth individual semi-structured interviews post-therapy to explore their experiences of taking part in the study.
| Arm | Type | Receives |
|---|---|---|
| Immediate LUNA intervention | Experimental | Behavioral: LUNALUNA intervention between T1 and T2. No treatment between T2 and T3. LUNA intervention comprises 20hrs of face-to-face treatment, 2 sessions per week of 60 minutes each, for 10 weeks. One session is delivered by a qualified speech and language therapist; the other session is delivered by an assistant (student or volunteer) following guidance and under distance supervision. Both therapist and assistant will receive LUNA training. The treatment is specified in the TIDIER checklist. In brief, it aims to improve spoken discourse production, using personal narratives as assessment and treatment stimulate, and by integrating word, sentence and discourse level tasks. Treatment is manualised and has been codesigned with key stakeholders (providers and users). |
| Delayed LUNA intervention | Experimental | Behavioral: LUNAWait between T1 and T2. LUNA between T2 and T3. LUNA intervention as above |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of ischaemic or haemorrhagic stroke
- have aphasia due to a stroke that occurred at least 12 months prior to recruitment
- literate and fluent users of English prior to their stroke (self-reported)
- have adequate hearing and vision with aids and glasses, e.g. in order to see pictorial and written assessment and therapy materials
- must have access to a computer or tablet and an internet connection
Key exclusion criteria (4 listed)
- must not be receiving speech and language therapy elsewhere for the duration of the study. Usual stroke supports, for example provided by the voluntary sector, can proceed, although these are likely to be curtailed owing to COVID-19
- must not be participating in any other aphasia treatment research project for the duration of the study
- must not have severe aphasia, defined as a score of 7 or less on the Frenchay Aphasia Screening Test (FAST: Enderby et al., 1986; unlikely to benefit from treatment)
- must not have a secondary cognitive diagnosis such as dementia. This will be established via self-report and the confirmation of the group co-ordinator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUNAsee description above | Behavioural | Delayed LUNA intervention, Immediate LUNA intervention |
Primary outcome
Personal narratives measure (LUNA Discourse Protocol)
Time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Participants will produce two personal narratives at each assessment point, which will be video/audio recorded. They will be given instructions e.g. length of narrative, indication of topic etc. The narrative will be spoken face-to-face to the assessing therapist. S/he will not provide any cues or ask questions. Recording will cease when the participant indicates that the story is finished. Discourse samples will be analysed according to the LUNA Research Discourse Analysis Protocol. The analysis yields the following data: number and %narrative words, and number of narrative words/minute; %Correct Information Units( CIU); number of CIUs/minute; %complete utterances; %single versus multi-clause utterances; #1, 2, and 3 argument utterances; Predicate Argument Score; story grammar count of elements; global coherence score; local coherence score; reference chains count; and overall listener judgment. Number of narrative words is proposed as the primary discourse outcome.
5 secondary outcomes
The Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
Time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
The Communicative Participation Item Bank (CPIB) - General Short Form [Patient Reported Outcome Measure]
Time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
The Communication Confidence Rating Scale for Aphasia (CCRSA) [Patient Reported Outcome Measure]
Time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
The Assessment for Living with Aphasia (ALA) [Patient Reported Outcome Measure]
Time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Visual Analogue Mood Scales (VAMS) [Patient Reported Outcome Measure]
Time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 24829914Agostini M, Garzon M, Benavides-Varela S, De Pellegrin S, Bencini G, Rossi G, Rosadoni S, Mancuso M, Turolla A, Meneghello F, Tonin P. Telerehabilitation in poststroke anomia. Biomed Res Int. 2014;2014:706909. doi: 10.1155/2014/706909. Epub 2014 Apr 15.
- Background: PubMed 22592672Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3.
- BackgroundCruice, M., Woolf, C., Caute, A., Monnelly, K., Wilson, S. & Marshall, J. (2021) Preliminary outcomes from a pilot study of personalised online supported conversation for participation intervention for people with Aphasia, Aphasiology, 35:10, 1293-1317, DOI: 10.1080/02687038.2020.1795076
- Background: PubMed 32191122Dekhtyar M, Braun EJ, Billot A, Foo L, Kiran S. Videoconference Administration of the Western Aphasia Battery-Revised: Feasibility and Validity. Am J Speech Lang Pathol. 2020 May 8;29(2):673-687. doi: 10.1044/2019_AJSLP-19-00023. Epub 2020 Mar 19.
- BackgroundEnderby P, Wood V, Wade D. Frenchay aphasia screening test (FAST). West Sussex: Wiley; 1986.
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- BackgroundJulious, S.A. (2005), Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut. Statist., 4: 287-291. https://doi.org/10.1002/pst.185
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Cruice principal investigator
City, University of London
Prof Dipper principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LUNA in people with Aphasia and Stroke, run by City, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal narratives measure (LUNA Discourse Protocol) (time frame: Change from baseline (T1: weeks 1 and 2) to immediately post treatment (T2: weeks 13 and 14) to follow up (T3: weeks 25 and 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847023, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.