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Trial registered on ANZCTR


Registration number
ACTRN12624000229572p
Ethics application status
Submitted, not yet approved
Date submitted
19/01/2024
Date registered
7/03/2024
Date last updated
7/03/2024
Date data sharing statement initially provided
7/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid Syllable Transition Treatment for Adults.
Scientific title
Effectiveness of Rapid Syllable Transition Treatment for Apraxia of in Adults
Secondary ID [1] 311374 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Apraxia of Speech 332646 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329352 329352 0 0
Speech therapy
Neurological 329353 329353 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 x 1 hour sessions of Rapid Syllable Transition Treatment provided by a trained speech pathologist or a trained and supervised speech pathology student. Sessions will be twice per week for 6 weeks. Each session has a minimum dose of 100 repetitions of the treatment task.
Therapy will be provided on campus at the University of Sydney or by telehealth (patient choice).
No physical materials will be provided. No homework or adherence is required as treatment is provided in person. Treatment fidelity will be measured by the researchers watching videos of the sessions and counting adherence to the ReST manual by the treating clinician (i.e. not patient adherence)

This project is a pilot single case experimental design study to establish an effect size for a randomised controlled trial in the future.

ReST uses multisyllabic nonsense words individually chosen for each participant to improve the ability to speak clearly and smoothly, transition rapidly and fluently from one sound/syllable to the next, and control of the rhythm in the form of relative emphasis, or stress, placed on each syllable within a word (McCabe et al., 2017). ReST treatment teaches patients to say the nonsense words and gets them to copy a model of someone saying the nonsense word correctly. In doing so, the person with apraxia is required to practice planning to speak, thus it is believed that the treatment addresses their apraxic difficulty directly. Details about ReST treatment and video examples of the treatment with children are available at https://rest.sydney.edu.au
Intervention code [1] 327817 0
Rehabilitation
Intervention code [2] 327913 0
Treatment: Other
Comparator / control treatment
No control group - single case experimental within participant design in which participants act as their own control. Three-five baseline measures are collected preceding treatment over two weeks. Baseline measures are saying a word list.
Control group
Active

Outcomes
Primary outcome [1] 337169 0
Speech intelligibility. This refers to how easy it is to understand the person’s speech.
Timepoint [1] 337169 0
pre-treatment (2-0 weeks before treatment commences), 1 week post-completion (primary timepoint) and 3 months post-completion
Secondary outcome [1] 430963 0
Satisfaction
Timepoint [1] 430963 0
1 week post-intervention and 3 months post-intervention
Secondary outcome [2] 430964 0
Speech accuracy 1- Percent phonemes correct
Timepoint [2] 430964 0
Pre-treatment (2-0 weeks before treatment commences), 1 week post-intervention and 3 months post-intervention
Secondary outcome [3] 430965 0
Speech Accuracy 2 - Apraxia of Speech Severity Rating scale
Timepoint [3] 430965 0
Pre-treatment (2-0 weeks before treatment commences), 1 week post-intervention and 3 months post-intervention
Secondary outcome [4] 430966 0
Sentence complexity: Mean length of utterance (MLU) in speech
Timepoint [4] 430966 0
Pre-treatment (2-0 weeks before treatment commences), 1 week post-intervention and 3 months post-intervention

Eligibility
Key inclusion criteria
Diagnosis of apraxia of speech from any cause.
English speaker with functional literacy in English
Participants who choose to participate by telehealth will need to have their own laptop or tablet device and access to the internet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia or cognitive impairment limiting ability to individually consent.
Hearing loss sufficient to prevent participation (people with hearing aids / cochlear implants who can hear speech at 30dB or lower are included).
Vision loss which prevents reading of print at 20pt.
Any physical disability of the head or neck which has changed the accuracy of speech production e.g. dysarthria, head and neck cancer,
Any genetic or developmental diagnosis which affects speech or cognition such as Down Syndrome or Cerebral Palsy.
Another serious acquired neurological disorder which affects speech or cognition such as Parkinsons disease or Alzheimers.

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Single case experimental design methodology
1. visual analysis of within participant change, if present then
2. PND, IRD for individual analysis
3. d2 calculation for future sample size estimation

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
27/03/2026
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315633 0
University
Name [1] 315633 0
The University of Sydney
Country [1] 315633 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 317731 0
None
Name [1] 317731 0
Address [1] 317731 0
Country [1] 317731 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314517 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314517 0
The University of Sydney, Camperdown NSW 2006
Ethics committee country [1] 314517 0
Australia
Date submitted for ethics approval [1] 314517 0
19/01/2024
Approval date [1] 314517 0
Ethics approval number [1] 314517 0

Summary
Brief summary
Rapid Syllable Transition Treatment (ReST) is a speech pathology treatment which is effective for treatment of apraxia of speech in children and young people. We know it is being used clinically with adults however this has not been reported in the literature. Six adults will be provided with ReST treatment twice per week for six weeks. The research is a single-case experimental design using within participant control. Treatment will be provided by speech pathologists or supervised speech pathology students either online (zoom) or on-campus at the University of Sydney speech pathology clinic in the Susan Wakil Health Building in Camperdown NSW Australia.
We hypothesise that participants speech will improve as a result of the treatment.
Trial website
https://rest.sydney.edu.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131862 0
Prof Tricia McCabe
Address 131862 0
Professor Tricia McCabe, The University of Sydney, Susan Wakil Health Building, D18 Western Avenue Camperdown NSW 2006
Country 131862 0
Australia
Phone 131862 0
+61410245661
Fax 131862 0
Email 131862 0
tricia.mccabe@sydney.edu.au
Contact person for public queries
Name 131863 0
Prof Tricia McCabe
Address 131863 0
Professor Tricia McCabe, The University of Sydney, Susan Wakil Health Building, D18 Western Avenue Camperdown NSW 2006
Country 131863 0
Australia
Phone 131863 0
+61410245661
Fax 131863 0
Email 131863 0
tricia.mccabe@sydney.edu.au
Contact person for scientific queries
Name 131864 0
Prof Tricia McCabe
Address 131864 0
Professor Tricia McCabe, The University of Sydney, Susan Wakil Health Building, D18 Western Avenue Camperdown NSW 2006
Country 131864 0
Australia
Phone 131864 0
+61410245661
Fax 131864 0
Email 131864 0
tricia.mccabe@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data in spreadsheet form - [demographics: gender, age (in 10 year bands)], test scores, apraxia category (developmental, acquired), apraxia severity, telehealth vs in-person delivery
When will data be available (start and end dates)?
Data will be available from publication for 5 years
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Web address will be provided in the publication


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21447Study protocol https://rest.sydney.edu.au  387201-(Uploaded-19-01-2024-17-02-19)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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