Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000857404p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2025
Date registered
8/08/2025
Date last updated
8/08/2025
Date data sharing statement initially provided
8/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Speech therapy and aphasia rehabilitation in New Zealand hospitals
Scientific title
Evaluating the Effect of Comprehensive Individualised Aphasia Therapy Programmes on Degree of Linguistic Impairment and Quality of Life During Inpatient Stroke Rehabilitation Stays: a comparison against usual care
Secondary ID [1] 314688 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-stroke aphasia 337857 0
Condition category
Condition code
Physical Medicine / Rehabilitation 334190 334190 0 0
Speech therapy
Stroke 334470 334470 0 0
Haemorrhagic
Stroke 334473 334473 0 0
Ischaemic
Neurological 334474 334474 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive "Individualised, Comprehensive Aphasia Treatment". This treatment protocol has been created for the study and involves 1:1 speech-language therapy sessions, group therapy sessions (of 2 or more participants), education (on aphasia), and a supplementary home exercise programme.

Content: Content has been derived from evidenced-based practice, clinical guidelines and best practice recommendations for aphasia. All sessions (1:1, group and education sessions) will follow the hui process (see Lacey et al., 2011, The Hui Process: a framework to enhance the doctor– patient relationship with Maori, The New Zealand Medical Journal, 124, 72-78 for an overview). Kaupapa (treatment) will include a selection of evidence-based approaches that are relevant and meaningful for the individual participant’s goals. Education sessions will cover topics such as an overview of what aphasia is, common challenges, and conversation repair strategies. Supplementay exercise programmes may include: paper-based worksheets or use of computer programmes/apps to support evidence-based treatments, and/or practical transfer tasks.

Delivery agent: 50% of input will be delivered by a speech-language therapist with >5 years of experience working aphasia. 50% will be delivered by final year speech-language therapy students, who have completed course work in aphasia and an orientation programme created for the study, under the supervision of a speech-language therapist with >5 years of experience working with people with aphasia and supervising students.

Delivery mode: The mode delivery is face-to-face, with a combination of 1:1 and group therapy.

Intensity: The treatment will be provided over 2 weeks, with 10 x 1:1 treatment sessions (5 times a week for 2 weeks) and 2 group sessions (once per week for 2 weeks). 1:1 sessions , education sessions and group sessions will be approximately 45 minutes each. Home exercise programme nd may include: paper-based worksheets or use of computer programmes/apps to support evidence-based treatments, and/or practical transfer tasks will provide an additional 15 minutes or more of daily language exercises.

Location: The intervention will occur in hospital during inpatient admissions.

Adherence: Adherence will be assessed with the use of checklists for attendance and content of sessions.

Allocation: participants will be allocated to a condition (treatment or control) based on location of enrolment, with one site providing the treatment condition and the other providing ‘usual care’ as below.

Different from usual care: the major differences between the treatment condition and the control condition in this study include increased intensity of input in the treatment condition, the utilisation of group therapy, and the group education sessions.
Intervention code [1] 331307 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care.

Usual care participants will receive 1:1 speech-language therapy sessions, with content derived from evidence-based practice and clinical guidelines.

Usual care will be provided by a speech-language therapist.

The mode of delivery is face-to-face, 1:1 sessions. Sessions will be provided over 2 weeks with 6 x 1:1 sessions provided (3 times a week for 2 weeks). This will occur in hospital during inpatient admissions.

Adherence will be assessed with the use of checklists for attendance and content of sessions.
Control group
Active

Outcomes
Primary outcome [1] 341877 0
degree of linguistic impairment
Timepoint [1] 341877 0
baseline and 1-day post end of treatment program
Primary outcome [2] 341878 0
communicative function as rated by a proxy rater
Timepoint [2] 341878 0
baseline and 1 day post end of treatment
Primary outcome [3] 341879 0
self-rated quality of life
Timepoint [3] 341879 0
baseline and 1 day post end of treatment
Secondary outcome [1] 448856 0
self-rating of emotional well-being
Timepoint [1] 448856 0
baseline and end of treatment

Eligibility
Key inclusion criteria
- Stroke (cerebrovascular event/accident) confirmed through imaging
- Presence of aphasia confirmed with Quick Aphasia Battery (QAB)
- over 18 years old
- Inpatient on a participating stroke rehabilitation ward
- Able to complete aphasia assessment and treatment in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Aphasia not secondary to stroke
- Presence of a pre-existing or progressive neurological or psychiatric condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
19/06/2028
Actual
Date of last data collection
Anticipated
1/07/2028
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 27128 0
New Zealand
State/province [1] 27128 0

Funding & Sponsors
Funding source category [1] 319238 0
University
Name [1] 319238 0
University of Canterbury
Country [1] 319238 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Country
New Zealand
Secondary sponsor category [1] 321705 0
None
Name [1] 321705 0
Address [1] 321705 0
Country [1] 321705 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317816 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317816 0
Ethics committee country [1] 317816 0
New Zealand
Date submitted for ethics approval [1] 317816 0
04/07/2025
Approval date [1] 317816 0
Ethics approval number [1] 317816 0

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

Contacts
Principal investigator
Name 142246 0
Mrs Nicola Gibbons
Address 142246 0
University of Canterbury Speech-Language Neuroscience Lab | Te Puna Putaiao Ioio 20 Kirkwood Ave, Ilam, Christchurch, NZ.
Country 142246 0
New Zealand
Phone 142246 0
+64 3 369 0868
Fax 142246 0
Email 142246 0
[email protected]
Contact person for public queries
Name 142247 0
Nicola Gibbons
Address 142247 0
University of Canterbury Speech-Language Neuroscience Lab | Te Puna Putaiao Ioio 20 Kirkwood Ave, Ilam, Christchurch, NZ.
Country 142247 0
New Zealand
Phone 142247 0
+64 3 369 0868
Fax 142247 0
Email 142247 0
[email protected]
Contact person for scientific queries
Name 142248 0
Nicola Gibbons
Address 142248 0
University of Canterbury Speech-Language Neuroscience Lab | Te Puna Putaiao Ioio 20 Kirkwood Ave, Ilam, Christchurch, NZ.
Country 142248 0
New Zealand
Phone 142248 0
+64 3 369 0868
Fax 142248 0
Email 142248 0
[email protected]

Data sharing statement
Will the study consider sharing 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.