LUNA
Linguistic Underpinnings of Narrative in Aphasia (LUNA): A Proof-of-concept Study of a Novel Discourse Treatment for Aphasia Using Personal Narratives
Sponsor study identifier
interventional
28
1 country
1
Study Start
June 14, 2020
Actual (reported)Primary Completion
April 1, 2021
Actual (reported)Study Completion
April 28, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 28, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 14, 2020
Actual (reported)April 1, 2021
Actual (reported)April 28, 2021
Actual (reported)March 27, 2023
Actual (reported)May 6, 2023
Actual (reported)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.
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 Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ)
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]
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]
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]
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]
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)
Percentage of those eligible who consent
Week 27
Percentage of retention
Week 27
Percentage of treatment sessions attended with reasons for non-attendance
Week 27
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).
Wait between T1 and T2. LUNA between T2 and T3. LUNA intervention as above
see description above
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Language and Communication Science, City, University of London
London, United Kingdom
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.
Brady 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.
Prof Cruice
City, University of London
Prof Dipper
City, University of London
28 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2023
Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia
Contact the study team to confirm eligibility.
Cruice, 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.
Enderby 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.
Julious, 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.
Theodoros 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.
Wallace 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.
J. 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.
Cruice 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.
Dipper, L., Marshall, J., Boyle, M., Botting, N., Hersh, D., Pritchard, M., & Cruice, M. (2021) Treatment for improving discourse in aphasia: a systematic review and synthesis of the evidence base, Aphasiology, 35:9, 1125-1167, DOI: 10.1080/02687038.2020.1765305
Dipper L, Devane N, Barnard R, Botting N, Boyle M, Cockayne L, Hersh D, Magdalani C, Marshall J, Swinburn K, Cruice M. A feasibility randomised waitlist-controlled trial of a personalised multi-level language treatment for people with aphasia: The remote LUNA study. PLoS One. 2024 Jun 14;19(6):e0304385. doi: 10.1371/journal.pone.0304385. eCollection 2024.
First Posted
May 6, 2023
Study Start
June 14, 2020
Actual (reported)Primary Completion
April 1, 2021
Actual (reported)Study Completion
April 28, 2021
Actual (reported)Last Updated
May 6, 2023
Record last verified: 2023-04
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