COMPARE - An evaluation of two different treatments compared to usual speech pathology in people with problems communicating after stroke.

• Register: ANZCTR
• Last refreshed on: 5 January 2021
• Main ID: ACTRN12615000618550
• Date of registration: 15/06/2015
• Prospective Registration: Yes
• Primary sponsor: La Trobe University
• Public title: COMPARE - An evaluation of two different treatments compared to usual speech pathology in people with problems communicating after stroke.
• Scientific title: COMPARE - Constraint Induced or Multi-Modal aphasia rehabilitation versus usual care for stroke related chronic aphasia as measured by the change in the Western Aphasia Battery- Aphasia Quotient (AQ) score post-intervention compared to baseline.
• Date of first enrolment: 22/06/2016
• Target sample size: 216
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000618550.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia, New Zealand

Contacts

• Name: Mrs Melanie Hurley

• Name: A/Prof Miranda Rose

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria
Participants will be included if they:
1. Have a documented stroke resulting in aphasia at least 6 months prior to assessment at the time of consent
2. Have aphasia of any type (<93.8 WAB-AQ)
3. Used English as their primary language prior to stroke
4. Are 18 years or older and able to give informed consent
5. Are independent in toileting
6. Are able and willing to attend/participate in baseline assessments, 2 week treatment period, post-intervention period and follow up period
7. Have a carer/significant other who is able and willing to participate in baseline, post-intervention and follow up assessments.

The sub-study is optional for participants randomized to the UC group and as such willingness to participate in the sub-study is not a limiting factor for inclusion into the study.

Carer/significant other as nominated by the participant will be included if they:
1. Are 18 years or older and able to give informed consent
2. Are able and willing to participate in baseline, post-intervention period and follow up assessments

A carer/significant other is nominated by the participant and is not a limiting factor for inclusion into the study.
Exclusion criteria: Exclusion criteria
Participants will not be included if they:
1. Have had previous neurological event/diagnosis (head injury, neurosurgery, dementia, epilepsy, progressive neurological disorder) other than stroke
2. Have severe apraxia of speech or dysarthria on Apraxia Severity Rating Scale.
3. Have been diagnosed major clinical depression or other mental health condition that may affect involvement or adherence to the study protocol
4. Have uncorrected sensory loss (hearing/vision) preventing participation in communication assessments and treatments
5. Are unable to attend the 12 week follow-up assessments
6. Have any other serious medical condition including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate or in the opinion of the study investigator would prevent adherence to the protocol.
7. Are participating in any other therapy (including alternative therapies and clinical trials) or taking medications (including herbal preparations) that are not considered to be standard care for people with aphasia.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Aphasia post stroke;
Aphasia post stroke

Stroke - Haemorrhagic

Stroke - Ischaemic

Intervention(s)

Arm 1: Constraint Induced Aphasia Therapy (CIAT):
CIAT involves participants producing nouns, verbs, and functional phrases that they have not been able to produce prior to treatment, in response to pictured object and action cards, in a small social group setting. Physical visual barriers between participants discourage the use of gesture, drawing or writing as alternative means of communication when speech fails. Communication activities include requesting picture cards from group members (e.g., Do you have 'coffee'?), responding to requests from others (e.g., “Yes I have 'coffee'”), and rehearsal of functional communication routines (e.g., role playing being in a shop asking for coffee). Clinicians explicitly cue and shape the verbal responses such that, as performance improves, participant responses are shaped from simple, single word requests (e.g., “Coffee?”) through to more elaborate sentences (e.g., “John, I want a large, black coffee?”). CIAT Plus developed by CI Meinzer and colleagues also includes daily home practice (monitored via written log/carer report), which we will utilize in this study. There will be 30 hrs of treatment (3hrs/day, 5 days/week for 2 weeks), in a small group setting (2-3 participants per group) with one qualified speech pathologist.

Arm 2: Multi-Modality Aphasia Therapy (M-MAT):
M-MAT involves the same communication activities in the same setting as CIAT (socially inspired card based requesting and responding), but there are no visual barriers between participants. Clinicians explicitly cue and shape the verbal responses from participants with a series of structured multi-modal prompts that participants copy: associated gesture, written word, simple drawing, and verbal repetition. Daily home practice tasks are set and

Primary Outcome(s)

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score post-intervention compared to baseline. [Post-intervention - immediately after completion of intervention period.]

Secondary Outcome(s)

Relationship between lesion location and change in WAB-AQ score post-intervention and at 12 week follow-up[Immediately after and 12 weeks after intervention period]

Change in Communicative Effectiveness Index (CETI) post-intervention and at 12 week follow up compared to baseline.

The CETI is a 16-item spouse/carer rating scale of functional communication. [Immediately after and 12 weeks after intervention period.]

Change in Connected speech measures post-intervention and at 12 week follow up compared to baseline.

Connected speech measures will be collected and analysed using the SALT software. Samples include a picture description (from the WAB), picture description form the Nicholas and Brookshire procedure, a 5 minute monologue (stroke story; happy event) procedure and a 10-minute conversation between the participants and their nominated relative/friend or carer. [Immediately after and 12 weeks after intervention.]

Resource utilisation – economic analysis

Resource utilisation will be assessed through the use of a weekly participant diary, trial cost questionnaire and quality of life questionnaire.

Health-related quality of life (HRQoL) will be assessed using a standardised instrument, the EQ-5D-3L™. It is a cognitively simple questionnaire of five dimensions of health: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. [12 weeks after intervention period]

Optional sub-study outcome

Change in the WAB-AQ post-intervention main study compared to post-intervention sub-study[Up to 20 weeks after main study intervention period.]

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score at 12 week follow up compared to baseline.

The WAB-AQ is calculated as a sum of subtests including measures of spontaneous speech (fluency and information), auditory comprehension, repetition and naming. [12 weeks after completion of intervention period]

Change in WAB-AQ at 12 week follow up as predicted by by scores on semantic processing (Pyramids and Palm Trees), phonological processing (Naming Battery Phonological errors), non-verbal reasoning (Raven’s Matrices), cognitive flexibility (Test of Everyday Attention: Visual Elevator) , auditory verbal memory (Picture Span Test) and attention (Test of Everyday Attention)[12 weeks after intervention period]

Change in Scenario Test post-intervention and at 12 week follow up compared to baseline.

The Scenario Test measures daily-life communication for people with moderate to severe aphasia. It examines verbal (speaking) and nonverbal (gesture, drawing, writing) communication in an interactive setting with pictorial supports to assist in message comprehension. [Immediately after and 12 weeks after intervention period.]

Change in Stroke and Aphasia Quality of Life Scale (SAQOL-39g) post-intervention and at 12 week follow up compared to baseline.

SAQOL-39g is an interviewer administered self-report measure of subjective evaluation of functioning in 39 questions covering 3 domains: physical, psychosocial, and communication. It is specifically designed for people with aphasia with several modifications to improve accessibility (simple wording, large font, bolded text, visual rating scale). [Immediately after and 12 weeks after intervention period.]

Optional sub-study outcome

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score post-intervention compared to baseline. [Immediately after sub-study intervention period.]

Optional sub-study outcome

Change in the Western Aphasia Battery- Aphasia Quotient (AQ) score at 12 week follow up compared to baseline. [12 weeks after sub-study intervention period]

Secondary ID(s)

None

Source(s) of Monetary Support

National Health and Medical Research Council (NH&MRC)

Ethics review

Status: Approved
Approval date: 22/07/2015
Contact:

La Trobe University Human Research Ethics Committee

Status: Approved
Approval date: 26/10/2015
Contact:

Monash University Human Research Ethics Committee

Status: Approved
Approval date: 24/02/2016
Contact:

Gold Coast Hospital and Health Service human Research Ethics Committee

Status: Approved
Approval date: 07/04/2016
Contact:

The University of Queensland Human Research Ethics Committee

Status: Approved
Approval date: 18/08/2016
Contact:

Macquarie University Human Research Ethics Committee

Status: Approved
Approval date: 26/08/2016
Contact:

Edith Cowen University Human Research Ethics Committee

Status: Approved
Approval date: 24/08/2018
Contact:

University of Auckland Human Participants Ethics Committee

Results

• Results available: Yes
• Date Posted: 10/12/2020
• Date Completed: 23/07/2020