Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625001085460p
Ethics application status
Submitted, not yet approved
Date submitted
1/08/2025
Date registered
7/10/2025
Date last updated
7/10/2025
Date data sharing statement initially provided
7/10/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
A trial of voice assistant speech therapy for young people with dysarthria
Query!
Scientific title
A pilot trial of the tolerability and utility of voice assistant-based speech therapy for young people with perisylvian PMG or FOXP1 syndrome with associated dysarthria
Query!
Secondary ID [1]
314016
0
nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
dysarthria
338165
0
Query!
speech disorder
338166
0
Query!
Condition category
Condition code
Neurological
334448
334448
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The therapy approach being trialed is a four-week period of semi-structured, guided use of a voice assistant (specifically Amazon’s ‘Alexa’) for speech therapy. We will recruit participants with the speech disorder dysarthria, from two subgroups: (i) Perisylvian PMG; (ii) FOXP1 syndrome. This is a cross over trial - all participants will complete 4 weeks of treatment or 4 weeks of control, then swap to the opposite condition. There will be 4 weeks of washout between each condition. Each subgroup will include 6 participants, who will be randomised equally to each of the two sequences (Sequence A treatment then control (n=3 PMG and 3 FOXP1); Sequence B control then treatment (n=3 PMG and 3 FOXP1)).
This therapy will be completed by the participant in their home. Participants assigned to the intervention arm will be sent the following items:
1. A voice assistant device by courier.
2. An introductory email containing:
a. A prerecorded video showing how to set up the device in the family’s home (e.g. how to connect it to the internet, where to place the device to reduce background noise).
b. A therapy plan outlining the family’s timeline in the study, important dates (e.g. assessment dates) and the questions for the participant to ask Alexa during each speech practice session. An accompanying video of an example session will also be produced and sent to families.
During the four-week period that the participant is assigned to the voice assistant treatment arm, they will be asked to complete at least 1 session a day. We anticipate that each session will take 10-15 minutes. Parents will facilitate each session as per the therapy plan provided (detailed above), according to the following general structure:
1. Repeated sentences (5): Parent tells (verbally) participant five sentences to ask Alexa. These sentences will be different each day, and prescribed by the research team in the PDF therapy plan. It will be up to the participant to include the wake word (“Alexa”). For example, the parent would ask “Tell me what the weather is today”; ? child: “Alexa, tell me what the weather is today.”
2. Participant generated sentences (5): Parent will prompt child to ask Alexa five additional sentences, which will be generated by the participant. For participants who cannot generate a novel question, parents will be given prompts in the PDF therapy plan to ask participant. For example: Parent “Can you ask Alexa about the football score?” ? child: “Alexa, what is the footy score?”
Participants will be encouraged to use the device outside of the facilitated session per day, however additional use will not be prescribed. In this sense, the facilitated session is acting as the minimum dosage. Any additional usage will be additional dosage. Dosage will be tracked using written transcripts which are automatically recorded by Alexa. We will ask parents to send us these transcripts and audio recordings at the close of the four-week intervention period. Parents will be guided to do this during the telehealth assessment session at the close of the intervention period. These recordings will be saved by the study team. Parents will be asked not to interact with Alexa (on the device used for the trial), to ensure recordings and transcripts relate to the trial. Should parents or other members of the house use Alexa on the trial device accidentally, parents will be given an opportunity to delete these incidental recordings, prior to sending these to the study team. Parents will be guided to do this over the phone or Zoom by a member of the research team.
Query!
Intervention code [1]
331490
0
Treatment: Other
Query!
Comparator / control treatment
Participants assigned to the control arm will complete standard care. There is no treatment allocated at this time. Goals and focus of standard care (e.g. attendance at private speech pathology sessions) will be documented in a weekly Concomitant Therapy Diary completed by parents.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
342272
0
To describe the parent/caregiver and patient experience of the tolerability and utility of a four-week period of voice assistant speech therapy.
Query!
Assessment method [1]
342272
0
Parents will complete our weekly Tolerability and Use questionnaire to measure their perception of the voice assistant speech practice sessions and therapy plan to deliver speech therapy. This measure will be taken at weekly intervals throughout the treatment arm of the trial (i.e. weekly between timepoints T1-T2 or T3-T4 depending on the participant’s allocated sequence). Parents will complete our Tolerability, Utility and Global Efficacy questionnaire to provide feedback on their experience of the therapy approach and format of the intervention arm of the trial. This questionnaire will be taken at the close of the intervention arm (T2 or T4 depending on the participant’s allocated sequence). Parents will also complete our Final Tolerability, Utility and Global Efficacy questionnaire to provide feedback on their experience of the therapy approach and format of the trial overall. This questionnaire will be taken at T5
Query!
Timepoint [1]
342272
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention T5: 16 week post commencement of intervention
Query!
Secondary outcome [1]
450217
0
To describe the changes in objective, acoustic clinical speech features of vocal timing following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria
Query!
Assessment method [1]
450217
0
Performance on the following speech tasks will be recorded and analysed using Redenlab: • Sustained phonation, • DDK (i.e., papapa), • Automatic speech (i.e., counting to 10), • Connected speech sample. This will be assessed as a composite outcome.
Query!
Timepoint [1]
450217
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Secondary outcome [2]
450218
0
To describe the clinician perceived changes in speech quality, following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria. This will be assessed as a composite outcome.
Query!
Assessment method [2]
450218
0
Performance on the following speech tasks will be recorded using Redenlab: • Automatic speech (i.e., counting to 10), • Connected speech sample. Two speech clinicians blinded to the trial condition will describe speech based on performance in the above two tasks, according to scores on the ProCAD auditory-perceptual feature list as per Iuzzini-Seigel et al (2022) utilising components of the Mayo clinic motor speech feature rating scale (Duffy et al., 2012).
Query!
Timepoint [2]
450218
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Secondary outcome [3]
450219
0
To describe clinician perceived changes in speech intelligibility, following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria
Query!
Assessment method [3]
450219
0
Preschool Speech Intelligibility Measure (PSIM, Morris et al., 1995).
Query!
Timepoint [3]
450219
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Secondary outcome [4]
450220
0
To describe the patient-perceived changes in speech intelligibility, following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria
Query!
Assessment method [4]
450220
0
Communication Effectiveness Survey (Participant Form, Donovan, Velozo & Rosenbek, 2007)
Query!
Timepoint [4]
450220
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Secondary outcome [5]
450221
0
To describe the parent-perceived changes in speech intelligibility, following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria. This will be assessed as a composite outcome.
Query!
Assessment method [5]
450221
0
Communication Effectiveness Survey (Communication Partner Perspective Form; Donovan, Velozo & Rosenbek, 2007), the Intelligibility in Context Scale (McLeod et al., 2012) and a modified version of the Dysarthria Impact Profile (Vogel et al., 2025).
Query!
Timepoint [5]
450221
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Secondary outcome [6]
450222
0
To assess the feasibility of the study design.
Query!
Assessment method [6]
450222
0
Feasibility of the study design will be evaluated by recording: • recruitment uptake (i.e., how easy or difficult it was to recruit participants, based on audit of study records); • adherence (based on audio and written transcripts of the participant’s interaction with the device) and; • follow-up (description of losses to follow up, including frequency and reasons for losses to follow-up based on audit of study records).
Query!
Timepoint [6]
450222
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention T5: 16 week post commencement of intervention
Query!
Secondary outcome [7]
451879
0
To describe the changes in objective, acoustic clinical speech features of vocal control following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria
Query!
Assessment method [7]
451879
0
Performance on the following speech tasks will be recorded and analysed using Redenlab: • Sustained phonation, • DDK (i.e., papapa), • Automatic speech (i.e., counting to 10), • Connected speech sample. This will be assessed as a composite outcome
Query!
Timepoint [7]
451879
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Secondary outcome [8]
451880
0
To describe the changes in objective, acoustic clinical speech features of vocal quality following four weeks of voice assistant speech therapy or control, compared to baseline, in young people with dysarthria
Query!
Assessment method [8]
451880
0
Performance on the following speech tasks will be recorded and analysed using Redenlab: • Sustained phonation, • DDK (i.e., papapa), • Automatic speech (i.e., counting to 10), • Connected speech sample. This will be assessed as a composite outcome
Query!
Timepoint [8]
451880
0
T1: Baseline T2: 4 weeks post commencement of intervention T3: 8 weeks post commencement of intervention T4: 12 weeks post commencement of intervention
Query!
Eligibility
Key inclusion criteria
Common inclusion criteria:
To be enrolled in this trial, all participants must meet the following eligibility criteria, in addition to the relevant specific inclusion criteria for their respective group, as below:
• Aged between 10-25 years at the time of randomisation.
• Has dysarthria.
• Can speak in single words and short sentences. This is to ensure they can perform the speech tasks required for outcome measures in the trial.
• Can provide a signed and dated informed consent form OR has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
• Can commit to the time requirements of the trial.
• Has English as a first language.
• Has access to stable internet connection. This is to ensure they can perform the online assessment tasks and can connect the voice assistant device to the internet.
• Is willing to use their existing Amazon account, or to create a new (free) account with guidance from the research team, for use during the trial.
Specific inclusion criteria for Group A: PMG
• Has a diagnosis of perisylvian PMG, confirmed by MRI report or letter from a neurologist.
Specific inclusion criteria for Group B: FOXP1 syndrome
• Has a diagnosis of FOXP1 syndrome, confirmed by genetic report showing a pathogenic or likely pathogenic FOXP1 variant according to the American College of Medical Genetics guidelines (Richards et al., 2015).
Query!
Minimum age
10
Years
Query!
Query!
Maximum age
25
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
• Has an additional, diagnosed genetic or neurological condition known to affect speech and language.
• Visual or hearing problems that, in the view of the site principal investigator, significantly impact on the validity or reliability of speech testing.
• Independently uses a voice assistant regularly (defined as use > twice every day) prior to commencing the trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After informed consent and screening have been successfully completed, a research assistant not directly involved in the analysis of speech outcome measures will randomize participants to either Sequence A (treatment then control) or Sequence B (control then treatment) using REDCap’s randomisation tool. A block randomization approach will be followed and there will be no stratification factors.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
10/11/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
27/04/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
28/09/2026
Query!
Actual
Query!
Sample size
Target
12
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
318520
0
University
Query!
Name [1]
318520
0
The University of Melbourne
Query!
Address [1]
318520
0
Query!
Country [1]
318520
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Dr Ruth Braden - The University of Melbourne
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320912
0
University
Query!
Name [1]
320912
0
The University of Melbourne
Query!
Address [1]
320912
0
Query!
Country [1]
320912
0
Australia
Query!
Ethics approval
Ethics application status
Submitted, not yet approved
Query!
Ethics committee name [1]
317126
0
University of Melbourne Central Human Research Ethics Committee
Query!
Ethics committee address [1]
317126
0
The University of Melbourne Central Human Research Ethics Committee. The University of Melbourne Grattan Street, Parkville Victoria 3010 Australia
Query!
Ethics committee country [1]
317126
0
Australia
Query!
Date submitted for ethics approval [1]
317126
0
03/10/2025
Query!
Approval date [1]
317126
0
Query!
Ethics approval number [1]
317126
0
Query!
Summary
Brief summary
This pilot, crossover trial will recruit 12 participants aged 10-25 years with dysarthria. Participants will compete 4 weeks of speech therapy using a voice-assistant device, according to a therapy plan provided by the research team. The aim of this study is to describe the parent/caregiver and patient experience of the tolerability, safety and utility of a four-week period of voice assistant-based speech therapy, using the 'Alexa' system. Pre/post changes in speech intelligibility, and perceptual and acoustic speech quality will also be explored.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
140082
0
Dr Ruth Braden
Query!
Address
140082
0
The University of Melbourne, Department of Audiology and Speech Pathology, 550 Swanston St Carlton VIC 3053
Query!
Country
140082
0
Australia
Query!
Phone
140082
0
+61 383440629
Query!
Fax
140082
0
Query!
Email
140082
0
[email protected]
Query!
Contact person for public queries
Name
140083
0
Ruth Braden
Query!
Address
140083
0
The University of Melbourne, Department of Audiology and Speech Pathology, 550 Swanston St Carlton VIC 3053
Query!
Country
140083
0
Australia
Query!
Phone
140083
0
+61 383440629
Query!
Fax
140083
0
Query!
Email
140083
0
[email protected]
Query!
Contact person for scientific queries
Name
140084
0
Ruth Braden
Query!
Address
140084
0
The University of Melbourne, Department of Audiology and Speech Pathology, 550 Swanston St Carlton VIC 3053
Query!
Country
140084
0
Australia
Query!
Phone
140084
0
+61 383440629
Query!
Fax
140084
0
Query!
Email
140084
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
[email protected]
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.
Download to PDF