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Trial registered on ANZCTR
Registration number
ACTRN12624000946516
Ethics application status
Approved
Date submitted
25/05/2024
Date registered
5/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of Dynamic Tactile Temporal Cueing in improving speech and communicative participation in children with cerebral palsy: An exploratory sequential mixed methods study
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Scientific title
Effectiveness of Dynamic Tactile Temporal Cueing in improving speech and communicative participation in children with cerebral palsy aged 3 to 8 years: An exploratory sequential mixed methods study
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Secondary ID [1]
311538
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy
332891
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Dysarthria speech disorder
332892
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Condition category
Condition code
Neurological
329608
329608
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Dynamic Tactile Temporal Cuing (DTTC) is a motor speech intervention designed for young children with severe motor speech disorders including childhood apraxia of speech (CAS), a similar condition to dysarthria in cerebral palsy. DTTC focuses on learning to move the muscles required for speaking while learning to say words.
DTTC involves stimulation techniques of “look at me, listen to me, say what I say”. A set of 20 meaningful target words that contain sounds that the child already can produce and those sounds that are emerging are practiced in intensive drill.
The speech pathologist systematically works toward independent (non-imitated) production of the words by fading cues in a cueing hierarchy. The cues include slow speaking rate, the length of time between clinician model and child’s response, and tactile cues to demonstrate articulatory configurations (the movements and placement of the tongue, cheeks, and lips). Rapid reinforcers (feedback on the correctness of the production and on how to produce the word/ phrase) are used to maximize the number of practice trials per session. Cues are individual to the child and the clinician moves along the cuing hierarchy to facilitate accurate production while moving towards independent production.
DTTC intervention will be provided three times a week for six weeks by speech pathologists trained in DTTC intervention. Each session runs for one hour. The sessions will be in-person at a Cerebral Palsy Alliance site closest to the participant's home.
All treating speech pathologists will undergo training for DTTC a minimum of one month before the commencement of the intervention. The following training will take place:
1. Complete DTTC online training https://childapraxiatreatment.org/dttc/.
2. Complete a three-hour training on the implementation of DTTC, delivered over two or three sessions depending on the speech pathologist’s availability. The CI or the other speech pathologists in the research team will provide the training individually to each speech pathologist or in groups of two online or in-person. A standardized DTTC intervention manual will be developed and used in the training.
3. The CI or the other speech pathologists in the team will observe the treating clinician’s first or the second treatment session with their first participant after which they will provide coaching feedback to the speech pathologist.
Adherence to DTTC intervention will be monitored by the Chief Investigator (CI) and the other speech pathologists in the research team. In addition to the initial clinician observation, the CI or the other speech pathologists will also observe three more randomly selected treatment sessions to observe fidelity to the DTTC intervention. If Fidelity drops below 90%, the speech pathologist will be provided with further training and support by the Chief Investigator or other speech pathologists in the research team.
The length of baselines:
Following the pre-treatment assessment, children will be randomized to complete 3, 4 or 5 pre-treatment probe assessments during baseline period. Children will be randomized to one of the following conditions:
- 3 pre-treatment probes: 2 x on 1 week before treatment and 1x on the first week of treatment
- 4 pre-treatment probes: 1 x on 2 weeks before treatment, 2 x 1 week before treatment, 1 x 1 on
the first week of treatment.
- 5 pre-treatment probes: 2 x on 2 weeks before treatment, 2 x 1 week before treatment, 1 x 1 on
the first week of treatment
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Intervention code [1]
327996
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Treatment: Other
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Comparator / control treatment
The multiple baseline measures in this single-case experimental study will be used to establish stable pre-treatment probe measures. The same probe measures will continue to be taken weekly throughout the treatment and five more time after the treatment. To calculate treatment effect, the baseline probe measures will be compared to the probe measures during the treatment within each individual participant. There are no control groups in this study. Each participant is measured against their own behavior.
The probe measures will be a 50-item wordlist, individualized to each child which includes 20 to-be-treated (the intervention target words), 20 untreated-but-related (words similar to the target words but not treated) and 10 control words (individually chosen for each child that are not predicted to improved based on DTTC treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Percentage of phonemes correct in the target words (PPC_TrW)
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Assessment method [1]
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The assessment method of the primary outcome of percentage of phonemes correct will involve the calculation of the percentage of phonemes correct in 20 target words obtained with the Diagnostic Evaluation of Articulation and Phonology (Dood et al., 2002)
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Timepoint [1]
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The primary outcome measure will be taken at:
1) At pre-commencement, minimum of 3 weeks before commencement of therapy.
2) At baseline 1 or 2 weeks before commencement of therapy (the participants will be randomised to 3,4 or 5 baseline measures).
3) Once a week for the duration of therapy.
4) 2 times at 1 week post intervention completion.
5) 2 times at 2 weeks post intervention.
6) 1 time at 4 weeks post intervention.
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Secondary outcome [1]
431740
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Percentage of phonemes correct in 20 untreated single words (PPC_UtrSW)
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Assessment method [1]
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The assessment method of the primary outcome of percentage of phonemes correct will involve the calculation of the percentage of phonemes correct in 20 untreated words obtained with the Diagnostic Evaluation of Articulation and Phonology (Dood et al., 2002)
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Timepoint [1]
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The secondary outcome measure will be taken at:
1) At pre-commencement, minimum of 3 weeks before commencement of therapy.
2) At baseline 1 or 2 weeks before commencement of therapy (the participants will be randomised to 3,4 or 5 baseline measures).
3) Once a week for the duration of therapy.
4) 2 times at 1 week post intervention completion.
5) 2 times at 2 weeks post intervention.
6) 1 time at 4 weeks post intervention.
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Secondary outcome [2]
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Intelligibility in words (Int_W)
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Assessment method [2]
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The Word Intelligibility by Picture Identification test (WIPI) will be used. Six phonetically similar words, represented as pictures on one page, are presented to the participant who names one of the words. The rater matches the word against the pictures on the page and rates it in intelligibility.
The rating scale:
0 = not able to identify the word because of unintelligibility
1 = able to identify the word but speech is difficult to understand
2 = able to identify the word and speech is easy to understand
A percentage of intelligibility is calculated from the rating scale score.
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Timepoint [2]
435502
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The secondary outcome measure will be taken:
1) At pre-commencement, minimum of 3 weeks before commencement of therapy.
2) 2 weeks after the completion of the intervention block.
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Secondary outcome [3]
435503
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Parent reported outcomes on communicative participation (FOCUS)
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Assessment method [3]
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Focus On Communication Under Six assessment (FOCUS; (Thomas-Stonell et al., 2010) form will be emailed to the participating families to fill in. Once completed, the family will email the assessment form back to the CI.
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Timepoint [3]
435503
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The secondary outcome measure will be taken:
1) At pre-commencement, minimum of 3 weeks before commencement of therapy.
2) 2 weeks after the completion of the intervention block.
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Secondary outcome [4]
435506
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Parent reported outcomes on intelligibility and participation (ICS)
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Assessment method [4]
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The Intelligibility on Context Scale (ICS) (McLeod et al., 2015) form will be emailed to the participating families to fill in. Once completed, the family will email the assessment form back to the CI.
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Timepoint [4]
435506
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The secondary outcome measure will be taken:
1) At pre-commencement, minimum of 3 weeks before commencement of therapy.
2) 2 weeks after the completion of the intervention block.
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Secondary outcome [5]
435508
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Parent reported outcome on performance (COPM_P)
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Assessment method [5]
435508
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The Canadian Occupation Performance measure – Performance (COPM_P) (ØstensjØ et al., 2008) orm will be emailed to the participating families to fill in. Once completed, the family will email the assessment form back to the CI.
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Timepoint [5]
435508
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The secondary outcome measure will be taken:
1) At pre-commencement, minimum of 3 weeks before commencement of therapy.
2) 2 weeks post-completion of the intervention block
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Secondary outcome [6]
436500
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Parent/ guardian acceptability of DTTC (TFAQ_Pa)
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Assessment method [6]
436500
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The parent/ guardian will access the Theoretical Framework of Acceptability Questionnaire (Sekhon et al., 2017 ) and fill in online from The University of Sydney REDCap.
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Timepoint [6]
436500
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The secondary outcome measure will be taken:
1) 2 weeks after the completion of the intervention block.
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Secondary outcome [7]
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The treating speech pathologist acceptability of DTTC (TFAQ_SP)
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Assessment method [7]
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The treating speech pathologist will access the Theoretical Framework of Acceptability Questionnaire (Sekhon et al., 2017 ) and fill in online from The University of Sydney REDCap.
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Timepoint [7]
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The secondary outcome measure will be taken:
1) 1 week after the completion of the intervention block.
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Secondary outcome [8]
436502
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Parent’s/ Guardian’s reflections on experiences with DTTC. (Int_Pa)
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Assessment method [8]
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The parent/ guardian will attend a semi-structured interview with one member of the research team (Sarah Reedman) to discuss their reflections and experiences with DTTC to capture barriers and facilitators to implementation (Breimaier et al., 2015)
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Timepoint [8]
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The secondary outcome measure will be taken:
1) Within 4 weeks after the completion of the intervention block.
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Secondary outcome [9]
436503
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The treating speech pathologist's reflections on experiences with DTTC. (Int_SP)
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Assessment method [9]
436503
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The treating speech pathologists will attend a semi-structured interview with one member of the research team to discuss their reflections and experiences with DTTC to capture barriers and facilitators to implementation (Breimaier et al., 2015)
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Timepoint [9]
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The secondary outcome measure will be taken:
1) Within 2 weeks after the completion of the intervention block.
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Eligibility
Key inclusion criteria
1. Diagnosis of CP
2. Viking Speech Scale (VSS) II-IV
3. No diagnosed intellectual disability
4. Normal or adjusted-to-normal hearing and vision
5. English as primary language
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Minimum age
3
Years
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Concomitant genetic or neurodevelopmental disorder
2. Oral or facial structural deficit
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to the number of baseline measures 3,4 or 5 will take place in the following way:
A University of Sydney staff who is unrelated to the study will draw an unmarked envelope that will indicate the number of baseline probe assessments.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
This is an n or 1 randomised controlled trial, an experimental study featuring a non-concurrent, randomised multiple-baseline across subjects design followed by a single intervention.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Single case experimental design – sequential mixed methods across multiple baselines with participants
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/10/2024
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Actual
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Date of last participant enrolment
Anticipated
31/03/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
6
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
315835
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Charities/Societies/Foundations
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Name [1]
315835
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Cerebral Palsy Alliance Emerging Researcher Grant
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Address [1]
315835
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Country [1]
315835
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
317963
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None
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Name [1]
317963
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Address [1]
317963
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Country [1]
317963
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314690
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The University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
314690
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https://www.sydney.edu.au/research/research-integrity-and-ethics.html
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Ethics committee country [1]
314690
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Australia
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Date submitted for ethics approval [1]
314690
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25/03/2024
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Approval date [1]
314690
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29/07/2024
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Ethics approval number [1]
314690
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2024/HE000616
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Summary
Brief summary
Most children with cerebral palsy (CP) have a speech difficulty called dysarthria, which makes their speech unclear and difficult to understand. Sometimes dysarthria is so severe that the child is unable to speak at all. Dynamic Tactile Temporal Cuing (DTTC) is a motor speech intervention designed for young children with severe motor speech disorders including childhood apraxia of speech (CAS), a similar condition to dysarthria in CP. DTTC focusses on learning how to move the muscles required for speaking while learning to say words. This may be particularly suitable for children with CP and dysarthria, as CP is primarily a disorder of movement so the individual has difficulty is in moving and coordinating muscles, including the muscles used for speech. This study aims to investigate if DTTC improves speech clarity and intelligibility, leading to increased participation in conversations, and if these improvements last beyond therapy. We will also explore the perspectives of he parents/ guardians and the speech pathologists with DTTC via semi-structured interviews and a questionnaire. If the study confirms that DTTC improves speech, we will conduct a larger, externally funded study. This research aims to improve the lives of these children by enhancing their communication abilities and overall participation in daily conversations.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Marjut (Johanna) Korkalainen
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Address
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Cerebral Palsy Alliance, 187 Allambie Road, Allambie Heights, NSW 2100
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Country
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Australia
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Phone
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+61 456236323
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Fax
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Email
132406
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[email protected]
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Contact person for public queries
Name
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Johanna (Marjut) Korkalainen
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Address
132407
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Cerebral Palsy Alliance, 187 Allambie Road, Allambie Heights, NSW 2100
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Country
132407
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Australia
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Phone
132407
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+61 299758719
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Fax
132407
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Email
132407
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[email protected]
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Contact person for scientific queries
Name
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Marjut (Johanna) Korkalainen
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Address
132408
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Cerebral Paly Alliance, 187 Allambie Road, Allambie Heights, NSW 2100
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Country
132408
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Australia
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Phone
132408
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+61 456236323
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Fax
132408
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Email
132408
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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