ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Apraxia of Speech

Condition category

Condition code

Physical Medicine / Rehabilitation

Speech therapy

Neurological

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]

Rehabilitation

Intervention code [2]

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]

Speech intelligibility. This refers to how easy it is to understand the person’s speech.

Timepoint [1]

pre-treatment (2-0 weeks before treatment commences), 1 week post-completion (primary timepoint) and 3 months post-completion

Secondary outcome [1]

Satisfaction

Timepoint [1]

1 week post-intervention and 3 months post-intervention

Secondary outcome [2]

Speech accuracy 1- Percent phonemes correct

Timepoint [2]

Pre-treatment (2-0 weeks before treatment commences), 1 week post-intervention and 3 months post-intervention

Secondary outcome [3]

Speech Accuracy 2 - Apraxia of Speech Severity Rating scale

Timepoint [3]

Pre-treatment (2-0 weeks before treatment commences), 1 week post-intervention and 3 months post-intervention

Secondary outcome [4]

Sentence complexity: Mean length of utterance (MLU) in speech

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Camperdown NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

The University of Sydney, Camperdown NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/01/2024

Approval date [1]

Ethics approval number [1]

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

Prof Tricia McCabe

Address

Professor Tricia McCabe, The University of Sydney, Susan Wakil Health Building, D18 Western Avenue Camperdown NSW 2006

Country

Australia

Phone

+61410245661

Fax

tricia.mccabe@sydney.edu.au

Contact person for public queries

Name

Tricia McCabe

Address

Professor Tricia McCabe, The University of Sydney, Susan Wakil Health Building, D18 Western Avenue Camperdown NSW 2006

Country

Australia

Phone

+61410245661

Fax

tricia.mccabe@sydney.edu.au

Contact person for scientific queries

Name

Tricia McCabe

Address

Professor Tricia McCabe, The University of Sydney, Susan Wakil Health Building, D18 Western Avenue Camperdown NSW 2006

Country

Australia

Phone

+61410245661

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
21447	Study 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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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