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Trial registered on ANZCTR


Registration number
ACTRN12616001261404
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
8/09/2016
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Apraxia World: An interactive technology-based therapy tool for childhood apraxia of speech.
Scientific title
Apraxia World: An interactive, technology-based comprehensive tool for remote speech therapy of childhood apraxia of speech (CAS).
Secondary ID [1] 290036 0
Nil
Secondary ID [2] 290062 0
nil
Universal Trial Number (UTN)
U1111-1186-9868
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childhood apraxia of speech 300082 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299968 299968 0 0
Speech therapy
Neurological 300000 300000 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Introduction: Our team have developed a system called Apraxia World that includes speech­driven games for tablets to deliver speech therapy exercises remotely, and speech processing algorithms required to extract disorder-specific variables for use in controlling gameplay and accurately monitoring therapy progress. The system enables true remote speech therapy by 1) including automated speech-processing capabilities to evaluate a child’s speech production attempts and provide the child with feedback on their performance accuracy, 2) providing feedback on the child’s performance to the speech-language pathologist (SLP) via a secure server, allowing SLPs to review progress made and manage multiple children remotely, and 3) enabling children to practice and learn new skills expeditiously via a tablet without having to schedule intensive and expensive therapy sessions. The images and vocabulary programmed into the table are based on the Nuffield Dyspraxia Programme Edition 3, which has been shown an efficacious approach for CAS (1-3).

We will clinically validate the use of remote speech therapy as an effective medium for intervention in CAS with this intervention effectiveness trial conducted through the University of Sydney.

This study will test the integrated Apraxia World system (games + tablet interface + clinician interface) in the field, evaluating (1) the child’s adherence to therapy and amount of practice completed using the system (data recorded through the system), (2) the child’s and parent’s experiences and satisfaction with the system (survey), and (3) the SLPs experiences and satisfaction with the system (survey).

Method: Up to 10 private SLPs from the local community in Sydney will be recruited via advertisements. SLPs who contact the research team will be enrolled in the study, provided with a recruitment flyer targeted to families of children with CAS, and asked to post the flyer in their waiting room. The flyer directs interested families to contact the research team; at that time the research team will identify which private SLP the family are seeing and inform the SLP that their client is enrolling.
The SLPs will be trained on the system and the intervention approach by the research team, although most will be familiar with the intervention approach already. Training will involve familiarisation with the server-clinician interface, gameplay in the app, and the Nuffield Dyspraxia Program; and will be set up with accounts for themself and their enrolled clients. This training should take about 1 hr in the SLPs clinic, with technical support offered by phone/email throughout the trial. The research team will contact the SLPs weekly to check for issues/progress.
The SLP will be asked to identify the speech behaviours that are appropriate for their client(s) to work on in therapy. This information will be used to select the appropriate therapy exercises on the tablet for each child. Following this, the SLP will train the child and parent(s) to ensure that they can navigate the tablet and understand the structure, purpose and goals of each of their assigned exercises (1 hr); researchers will be available to assist with/do this if requested by the SLP and family. The SLP will provide individual face-to-face therapy for the child in the clinic or the child’s home (as was occurring before the trial began), at their current frequency (typically 1 session of 1 hr / week), using the system, and prescribing homework activities for other days (as is customary). The family will be given the tablet for 12 weeks and instructed to continue their weekly sessions with the SLP and do a total of at least 45 minutes of practice a day for 4 days a week on the tablet-based exercises prescribed by the SLP. For all sessions undertaken by the child, speech attempts will be recorded, uploaded to the server­clinician interface, and automatically analyzed for key speech features (i.e., lexical stress, and speech sound accuracy). The SLP will be asked to view the recordings and/or data at least 1 – 2 times a week to track adherence, ensure the exercises are not too difficult, and replace old exercises with new ones once a skill / skill level is mastered. Weekly contact will be made with the SLPs to collect recordings and data and ensure the trial is on track.

(1) Nuffield Dyspraxia Programme. Available: http://www.ndp3.org/dyspraxia-therapy-overview.html
(2) Williams P. and H. Stephens, "Nuffield Centre Dyspraxia Programme," in Interventions for Speech Sound Disorders in Children, A. L. Williams, et al., Ed., ed: Brookes Pub., 2010.
(3) Murray, E., McCabe, P., & Ballard, K.J. (2015). A randomized controlled trial for children with childhood apraxia of speech comparing Rapid Syllable Transition Treatment and the Nuffield Dyspraxia Programme- Third Edition). Journal of Speech, Language, and Hearing Research, 58(3), 669-686. doi:10.1044/2015_JSLHR-S-13-0179.
Intervention code [1] 295761 0
Behaviour
Intervention code [2] 295783 0
Treatment: Other
Comparator / control treatment
Historical data are available on the effect size expected for a 3-week in-clinic paper-based delivery of the Nuffield Dyspraxia Program Ed. 3 intervention. This study was conducted in 2013-2014. The children were provided with 1 hr a day x 4 days / week for 3 weeks of therapy using the Nuffield Dyspraxia Program Ed. 3, with all therapy provided by an experienced SLP.
Murray, E., McCabe, P., & Ballard, K.J. (2015). A randomized controlled trial for children with childhood apraxia of speech comparing Rapid Syllable Transition Treatment and the Nuffield Dyspraxia Programme- Third Edition). Journal of Speech, Language, and Hearing Research, 58(3), 669-686. doi:10.1044/2015_JSLHR-S-13-0179.
Control group
Historical

Outcomes
Primary outcome [1] 299455 0
Parent's quality of experience with the system, as measured by an online survey developed for this study and completed by the parent.
Timepoint [1] 299455 0
Once at the completion of the 12-week trial
Primary outcome [2] 299574 0
Child's quality of experience with the system, as measured by an online survey developed for this study and completed by the child.
Timepoint [2] 299574 0
Once at the completion of the 12-week trial
Primary outcome [3] 299575 0
Speech-language pathologist's (SLP) quality of experience with the system, as measured by an online survey developed for this study and completed by the SLP.
Timepoint [3] 299575 0
Once at the completion of the 12-week trial
Secondary outcome [1] 327207 0
Total amount of home practice completed using the tablet (minutes) tracked by the automated tablet system.
Timepoint [1] 327207 0
Once at the completion of the 12-week trial
Secondary outcome [2] 327208 0
Distribution of practice (mins per session)
Timepoint [2] 327208 0
This measure will be collected automatically, by the software, for every session the child completes on the tablet (in the SLP's clinic or at home).
Secondary outcome [3] 327209 0
Percent of correct responses to tablet-based exercises per home-practice session, over all home-practice sessions in the 12 week trial (as determined by the speech processing algorithms)
Timepoint [3] 327209 0
This measure will be collected automatically, by the software, for every session the child completes on the tablet (in the SLP's clinic or at home).
Secondary outcome [4] 327310 0
Agreement between the speech processing algorithms and human (researcher) measurements of the children’s speech for lexical stress in multi-syllabic words.
Timepoint [4] 327310 0
Weekly for the 12 weeks of the trial
Secondary outcome [5] 327311 0
Agreement between the speech processing algorithms and human (researcher) measurements of the children’s speech for speech sound accuracy).
Timepoint [5] 327311 0
Weekly for the 12 weeks of the trial
Secondary outcome [6] 327312 0
Change in speech intelligibility, as rated by blinded unfamiliar listeners (% words understood).
Timepoint [6] 327312 0
First session on the tablet (week 1) and last session on the tablet (week 12).
Secondary outcome [7] 327313 0
Change in severity of speech impairment, as rated by blinded unfamiliar listeners using a 7-point Likert-type scale (1:unimpaired – 7:severely impaired).
Timepoint [7] 327313 0
First session on the tablet (week 1) and last session on the tablet (week 12).

Eligibility
Key inclusion criteria
1) SLPs currently in private practice and with at least one child on their caseload diagnosed with childhood apraxia of speech and showing the key diagnostic features of reduced articulatory accuracy for speech sounds in production of polysyllabic words and diadochokinesis (repetition of pataka), as well as syllable segregation and impaired lexical stress on production of polysyllabic words.
2) Children with CAS (see above) who are native-English speakers and have at least one parent who is a native English speaker.
Minimum age
4 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of dysarthria, oro-facial structural abnormality, cognitive or receptive language delay, other developmental diagnosis, or hearing impaired.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294407 0
Charities/Societies/Foundations
Name [1] 294407 0
Qatar Foundation (Qatar National Research Fund)
Country [1] 294407 0
Qatar
Primary sponsor type
Individual
Name
Dr Beena Ahmed
Address
Dept of Electrical and Computer Engineering
Texas A&M University at Qatar
Doha
Country
Qatar
Secondary sponsor category [1] 293255 0
Individual
Name [1] 293255 0
Prof Kirrie Ballard
Address [1] 293255 0
Faculty of Health Sciences
University of Sydney
East St
Lidcombe, NSW 2141
Country [1] 293255 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295827 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295827 0
Ethics committee country [1] 295827 0
Australia
Date submitted for ethics approval [1] 295827 0
Approval date [1] 295827 0
25/08/2015
Ethics approval number [1] 295827 0
2015/619

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

Contacts
Principal investigator
Name 68630 0
Dr Beena Ahmed
Address 68630 0
Texas A&M University at Qatar
Department of Electrical and Computer Engineering
Texas A&M Engineering Building
Education City
PO Box 23874
Doha
Country 68630 0
Qatar
Phone 68630 0
+974.4423.0111
Fax 68630 0
Email 68630 0
beena.ahmed@qatar.tamu.edu
Contact person for public queries
Name 68631 0
Kirrie Ballard
Address 68631 0
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe, NSW 2141
Country 68631 0
Australia
Phone 68631 0
+61 4 3141 6936
Fax 68631 0
Email 68631 0
kirrie.ballard@sydney.edu.au
Contact person for scientific queries
Name 68632 0
Kirrie Ballard
Address 68632 0
Faculty of Health Sciences
University of Sydney
East Street
Lidcombe, NSW 2141
Country 68632 0
Australia
Phone 68632 0
+61 4 3141 6936
Fax 68632 0
Email 68632 0
kirrie.ballard@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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