Childhood Apraxia of SpeechPICOSNCT07087249
Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
A study testing Ultrasound Visual Feedback and Waitlist in people with Childhood Apraxia of Speech and Speech Sound Disorders, run by Aline Mara de Oliveira at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the feasibility of the Ultrax protocol and estimate preliminary effects on articulatory precision, prosody, and speech motor planning. This is a pilot randomized clinical trial employing both quantitative and qualitative approaches. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Childhood Apraxia of Speech, Speech Sound Disorders
- What is being tested?
- Ultrasound Visual Feedback and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2026to 20 Jan 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Childhood Apraxia of Speech (CAS) confirmed by assessment; Age between 5 and 16 years; Monolingual speakers of Brazilian Portuguese; Normal auditory, cognitive, and receptive language skills; Normal results on orofacial screenings.
Who cannot join
- Hearing impairment or auditory processing disorders; Neurological, intellectual, or anatomical conditions affecting speech (e.g., cleft palate, cerebral palsy, dysarthria); Diagnosis of global motor development disorders; Bilingual speakers or individuals exposed to other languages at home.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Prof. Dr. Aline Mara de Oliveira
Florianópolis, Santa Catarina, 88085-174
Aline Mara Oliveira, Dr, 4899611229, fgaalinemaraoliveira@gmail.com
Aline de Oliveira
About this study
The aim of this study is to evaluate the feasibility of the Ultrax protocol and estimate preliminary effects on articulatory precision, prosody, and speech motor planning. This is a pilot randomized clinical trial employing both quantitative and qualitative approaches. Participants will be children aged five to twelve years diagnosed with Childhood Apraxia of Speech. The intervention will be conducted over six weeks, with two sessions per week. Following an initial assessment, participants will be randomized into either an intervention group or a waitlist control group. Assessments will be performed pre- and post-intervention, as well as at a one-month follow-up. Data analysis will be exploratory, focusing on evaluating the feasibility of the procedures and estimating parameters for future studies. Primary outcomes will include feasibility indicators such as recruitment rate, adherence, treatment fidelity, acceptability, and retention. Secondary outcomes will involve the analysis of preliminary speech performance measures and effect size estimation. The results are expected to provide preliminary effect estimates and inform the design of a definitive randomized clinical trial.
Read the detailed description
Ultrasound Biofeedback Intervention (Experimental Group): The experimental intervention involves intensive speech therapy augmented with real-time ultrasound tongue imaging as visual feedback. A portable ultrasound system with a small microconvex transducer is used, positioned submentally (under the child's chin) to capture a midsagittal view of the tongue.
. The ultrasound transducer emits safe, high-frequency sound waves, and the reflected signals produce a dynamic image of the tongue's surface on a monitor. Specialized software (such as Articulate Assistant Advanced (AAA) by Articulate Instruments Ltd.) is utilized to display and synchronize the ultrasound images with speech output.
During therapy, the child can see a real-time outline of their tongue moving on the screen as they attempt target sounds. This visual biofeedback serves as knowledge of performance - it allows the child to compare their tongue shape and placement against the therapist's model or a predetermined target shape. For example, the clinician may instruct the child to "lift the back of your tongue" for a velar sound and the ultrasound image immediately shows whether the child's tongue dorsum is reaching the correct position. A custom head-stabilization apparatus is often used to keep the probe steady and ensure consistent imaging. Throughout the ultrasound-assisted practice, the therapist provides cues and coaching based on the visual information (e.g. telling the child to aim the tongue toward a certain position on the screen) in addition to the typical auditory and tactile cues.
Control Intervention:
Therapy Targets and Session Structure: Therapy targets are individualized for each child based on their speech error profile, focusing on phonemes and word shapes that are challenging due to CAS. Targets include specific phonemes (speech sounds) and various syllable structures (e.g., CV syllables, CVC words, consonant clusters, and multisyllabic words) that the child has difficulty producing. For instance, a child who cannot accurately produce lingual consonants might have targets like /s/, /ʃ/, or /k/ in simple syllables ("sa", "ka") and in words of increasing complexity ("sapato", "cavalo", etc.). Control Intervention (Waitlist): The control group will not receive the intervention during the study; they will only be monitored via assessments. This group will receive the intervention at the end of the study.
Therapeutic Objectives and Session Structure: Therapeutic objectives are individualized for each child based on their speech error profile, focusing on phonemes and word structures that pose challenges due to Childhood Apraxia of Speech (CAS). Objectives include specific phonemes (speech sounds) and various syllable structures (e.g., CV syllables, CVC words, consonant clusters, and multisyllabic words) that the child struggles to produce. For example, a child unable to accurately produce lingual consonants might target sounds such as /s/, /ʃ/, or /k/ in simple syllables ("sa," "ka") and in words of increasing complexity ("sapato," "cavalo," etc.). Each participant undergoes a series of therapy sessions throughout the intervention. Sessions are typically scheduled multiple times per week (e.g., two sessions weekly) over several weeks to accumulate a high volume of practice attempts. Each session lasts approximately 45 to 60 minutes, following the ULTRAX protocol.
- Being tested
- Ultrasound Visual Feedback, Waitlist
- Keywords
- Speech Therapy, Motor Speech Disorder, Childhood Apraxia of Speech, Verbal Dyspraxia, Ultrasound Biofeedback
- Medical subject headings
- Apraxias, Speech Sound Disorder, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Visual FeedbackBehavioural
Speech therapy using real-time ultrasound imaging to provide visual feedback on tongue placement and movement. Aimed at improving speech accuracy and motor planning in children with Childhood Apraxia of Speech (CAS). The intervention follows principles of motor learning and includes 12 individual sessions over 6 weeks (twice per week). Practice alternates between ultrasound-assisted and non-assisted phases to promote generalization.
WaitlistOther
Waitlist patients who will receive the intervention after the study concludes.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: Ultrasound Visual Feedback | Experimental | Speech therapy using real-time ultrasound imaging to provide visual feedback of tongue movement. Designed for children with Childhood Apraxia of Speech (CAS). Sessions occur twice per week for six weeks (12 total), targeting speech motor planning and accuracy using motor learning principles. Receives: Behavioral: Ultrasound Visual Feedback |
| Waiting list | Active comparator | Waiting list that will receive treatment only after the research is completed Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Correct Consonants (PCC)
Percentage of correctly produced consonants(PCC) for treated and untreated stimuli: Generalization to novel words, phrases, sentence contexts and spontaneous speech; Maintenance of gains at follow-up;
Measured: Assessed at follow-up, 4 weeks after final therapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Apr 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion20 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood Apraxia of SpeechStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel arms: (1) experimental group with ultrasound visual biofeedback; (2) control group (waitlist).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aline Mara de Oliveira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aline Mara de Oliveira, Santa Catarina Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087249
- Sponsor's protocol ID
- 09476918.5.0000.0121
- Acronym
- PICOS
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to ethical and privacy considerations in accordance with Brazilian data protection laws and institutional review board policies.
Publications
Cleland J, McCluskey R, Dokovova M, Crampin L, Campbell L. A mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft palate +/- cleft lip: Parents' and children's perspectives. Int J Lang Commun Disord. 2025 Jan-Feb;60(1):e13144. doi: 10.1111/1460-6984.13144.
PubMed 39651790McCabe P, Preston JL, Evans P, Heard R. A Pilot Randomized Control Trial of Motor-Based Treatments for Childhood Apraxia of Speech: Rapid Syllable Transition Treatment and Ultrasound Biofeedback. Am J Speech Lang Pathol. 2023 Mar 9;32(2):629-644. doi: 10.1044/2022_AJSLP-22-00144. Epub 2023 Feb 27.
PubMed 36848673