Proof-of-concept Study of LUNA Intervention in Aphasia

NCT05847023 | Completed Phase 1

• 1 other identifier: TSA2017/01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Aphasia; Stroke

Keywords

Treatment; Feasibility study; Discourse

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• 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)

Other Outcomes (9)

• 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

Study Arms (2)

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).

Behavioral: LUNA

Delayed LUNA intervention

EXPERIMENTAL

Wait between T1 and T2. LUNA between T2 and T3. LUNA intervention as above

Behavioral: LUNA

Interventions

LUNA BEHAVIORAL

see description above

Delayed LUNA intervention; Immediate LUNA intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City, University of London: lead

Study Sites (1)

Department of Language and Communication Science, City, University of London

London, United Kingdom

Location

Related Publications (17)

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  PMID: 24829914 BACKGROUND

• 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.

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• 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

  BACKGROUND

• 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.

  PMID: 32191122 BACKGROUND

• Enderby P, Wood V, Wade D. Frenchay aphasia screening test (FAST). West Sussex: Wiley; 1986.

  BACKGROUND

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  PMID: 27802112 BACKGROUND

• 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

  BACKGROUND

• 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.

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• 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.

  PMID: 18729754 BACKGROUND

• 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.

  PMID: 27345867 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25911523 BACKGROUND

• 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.

  PMID: 32090417 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 38875279 DERIVED

MeSH Terms

Conditions

Aphasia; Stroke

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Prof Cruice

  City, University of London

  PRINCIPAL INVESTIGATOR

• Prof Dipper

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The LUNA Assessors (2 staff) were blinded to group allocation throughout the study. The statistician leading on analysis of initial efficacy findings was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 6, 2023
• Study Start: June 14, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 28, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)