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临床试验/NCT05847023
NCT05847023已完成1 期

Linguistic Underpinnings of Narrative in Aphasia (LUNA): A Proof-of-concept Study of a Novel Discourse Treatment for Aphasia Using Personal Narratives

City, University of London1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年6月14日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
28
试验地点
1
主要终点
Personal narratives measure (LUNA Discourse Protocol)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Personal narratives measure (LUNA Discourse Protocol)

时间窗: 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.

次要结局

  • 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 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))
  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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