Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000105448
Ethics application status
Approved
Date submitted
7/11/2024
Date registered
30/01/2025
Date last updated
16/02/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
M-MAT Tele: Maximising Aphasia Treatment and Recovery across Australia through Innovative Group Telerehabilitation
Scientific title
M-MAT Tele: Maximising Aphasia Treatment and Recovery across Australia through Innovative Group Telerehabilitation in people 3 - 12 months post stroke

Secondary ID [1] 313052 0
M-MAT Tele
Universal Trial Number (UTN)
Trial acronym
M-MAT Tele
Linked study record
M-MAT Tele is related to the M-MAT study ACTRN12615000618550 in that a similar intervention is used

Health condition
Health condition(s) or problem(s) studied:
Post stroke aphasia 335684 0
Aphasia 335683 0
Condition category
Condition code
Neurological 332243 332243 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 332244 332244 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
M-MAT Tele is a new telehealth version of M-MAT. Telerehabilitation reduces clinician and client travel and need for treatment space while addressing geographical inequity amongst people who have experience a stroke.

-The naming battery items from the COMPARE trial (ACTRN12615000618550) are used within custom made software (see doi: 10.1080/17483107.2024.2366423) which also contains sentence frames and exemplar multimodal cues (recorded gestures, drawings and spelling).

-Games Used in M-MAT Tele
All games require the participant to verbally direct the clinician for their turn using target words, phrases and sentences. Four games are used:
1. Memory - Participants find matching shapes hidden beneath naming pictures.
2. Bingo - Participants verbally claim shapes on their card (e.g., "I have a green salad").
3. Guess the Card - Participants place tokens on pictures using target sentences. Random selection determines points.
4. Snap - Participants identify cards turned over and claim matching pairs. This task focuses on rapid verbal retrieval and interaction.
Games are alternated based on group engagement, with changes recommended every hour.

Cueing Hierarchy
On failure of word retrieval, the clinician initiates a multi-modal cueing hierarchy:
1. Independent Gesture: Participants are prompted to produce a gesture of the target to support word retrieval. If this is unsuccessful, the remained of the hierarchy is completed in full.
2. Gesture: Therapist models the gesture and has the participant repeat the word verbally while gesturing.
3. Drawing: Participants create simple sketches to depict target words and repeat the word verbally.
4. Reading and Writing: Participants write and read the target aloud.
5. Sentence Repetition: Repetition of the full sentence three times to reinforce learning.
Other participants practice the multimodal cueing steps as well to maintain engagement and inclusivity.
Linguistic Levels
1. Single Words (Level 1): e.g., "Couch."
2. Carrier Phrases (Levels 2–4): e.g., "I’d like the red couch."
3. Full Sentences (Levels 5–7): e.g., "The girl is sitting lazily on the large red couch, but she should be at school."
Participants progress to higher levels upon achieving 80% accuracy without cues. Adjustments are made to ensure challenge and engagement, with modifications for non-standard sentence structures (e.g., verbs lacking direct objects).

-Paid, trained speech pathologists
-Online via Zoom and using custom made software (10.1080/17483107.2024.2366423)
-Thirty hours over five weeks. Three therapy days each week, with 2 hours of M-MAT Tele each day. Each session involves one hour of treatment followed by a 15-minute break and another hour of treatment
-Home practice/transfer tasks provided during the five weeks of intervention, plus 12 weeks of self directed maintenance activities during the follow up phase.
-Attendance logs are kept by therapists, as are detailed therapy records including start and stop times, number of utterances produced and percentage correct, linguistic levels targeted and the duration of any interruptions. Participants report back on their home practice and this is logged by therapists. Treatment fidelity is ensured through review of recordings of the first and midpoint sessions with feedback within 48 hours.
Intervention code [1] 330000 0
Treatment: Other
Intervention code [2] 329908 0
Rehabilitation
Comparator / control treatment
This is a waitlist- controlled study. Participants will be randomised to either receive M-MAT Tele, or to wait 5 weeks whilst having usual care, then commence M-MAT Tele. Usual care participants will undergo aphasia therapy at the type and frequency as is available to them through the rehabilitation centre they are receiving care at.
Control group
Active

Outcomes
Primary outcome [1] 339818 0
Retention
Timepoint [1] 339818 0
Immediately post intervention
Primary outcome [2] 339819 0
Acceptability
Timepoint [2] 339819 0
Taken within the 12 weeks post intervention completion
Secondary outcome [1] 444351 0
Mood
Timepoint [1] 444351 0
Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
Secondary outcome [2] 441504 0
Treatment fidelity >97% adherent
Timepoint [2] 441504 0
Taken within the 12 weeks post intervention completion
Secondary outcome [3] 444353 0
Word Retrieval
Timepoint [3] 444353 0
Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
Secondary outcome [4] 441506 0
Cost implications
Timepoint [4] 441506 0
12 weeks post intervention commencement
Secondary outcome [5] 441505 0
Communication related Quality of Life (QOL)
Timepoint [5] 441505 0
Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion
Secondary outcome [6] 444352 0
Functional Communication
Timepoint [6] 444352 0
Within a week of intervention/usual care phase completion and then (2) at 12 weeks follow up, i.e. 12 weeks after intervention completion

Eligibility
Key inclusion criteria
1. Diagnosis of aphasia as indicated by a Western Aphasia Battery Revised Aphasia Quotient of less than 93.8 (Kertesz et al., 2007)
2. Aged 18 years or over
3. Living in Australia
4. Stroke 3-12 months prior to commencement of intervention/usual care phase
5. Proficient in English prior to stroke
6. Willing to use videocall for telerehabilitation, using a tablet or computer
7. Able to attend/participate in all assessments and interventions
8. Internet connection at their place of residence of greater than or equal to 25mbps (NBN’s mandated minimum speed)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-stroke neurological diagnoses (e.g. head injury, neurosurgery, dementia)
2. Any “marked” or “severe” apraxia of speech or dysarthria as per the Apraxia of Speech Rating Scale 3.5 (Duffy et al., 2023)
3. High level of depression, as measured by SADQ-10 (Sutcliffe & Lincoln, 1998) at time of screening assessment, that would interfere with the ability to participate in the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by severity and completed within REDCap (Research Electronic Data Capture) with an allocation table generated by a person independent of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/11/2026
Actual
Sample size
Target
72
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 27298 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 27299 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 43388 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 43389 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 317492 0
Government body
Name [1] 317492 0
Australian Government Department of Health and Aged Care: Medical Research Future Fund
Country [1] 317492 0
Australia
Funding source category [2] 317779 0
Charities/Societies/Foundations
Name [2] 317779 0
Stroke Foundation
Country [2] 317779 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 320093 0
None
Name [1] 320093 0
Address [1] 320093 0
Country [1] 320093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316205 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316205 0
Ethics committee country [1] 316205 0
Australia
Date submitted for ethics approval [1] 316205 0
20/09/2024
Approval date [1] 316205 0
15/01/2025
Ethics approval number [1] 316205 0
HREC/111570/Austin-2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137138 0
Dr John Pierce
Address 137138 0
Aphasia CRE, Health Sciences Building 1 La Trobe University 1 Kingsbury Drive Bundoora Vic 3086
Country 137138 0
Australia
Phone 137138 0
+61 03 9479 6096
Fax 137138 0
Email 137138 0
[email protected]
Contact person for public queries
Name 137139 0
John Pierce
Address 137139 0
Aphasia CRE, Health Sciences Building 1 La Trobe University 1 Kingsbury Drive Bundoora Vic 3086
Country 137139 0
Australia
Phone 137139 0
+61 03 9479 6096
Fax 137139 0
Email 137139 0
[email protected]
Contact person for scientific queries
Name 137140 0
John Pierce
Address 137140 0
Aphasia CRE, Health Sciences Building 1 La Trobe University 1 Kingsbury Drive Bundoora Vic 3086
Country 137140 0
Australia
Phone 137140 0
+61 03 9479 6096
Fax 137140 0
Email 137140 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone

Conditions for requesting access:
• -

What individual participant data might be shared?
• All deidentified individual data

What types of analyses could be done with individual participant data?
• IPD meta analysis

When can requests for individual participant data be made (start and end dates)?
From:
Following publication, no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• IPD can be obtained by contacting the Chief Investigator Dr John Pierce in the Ahpasia CRE at La Trobe University via [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.