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RecruitingNCT07087249PICOSUpdated Oct 27, 2026

Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.

An interventional study of Ultrasound Visual Feedback and Waitlist in Childhood Apraxia of Speech and Speech Sound Disorders, sponsored by Aline Mara de Oliveira. Recruiting at 1 site in Brazil. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Aline Mara de Oliveira · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Updated Oct 27, 2026Eligibility revisedInterventions changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Childhood Apraxia of Speech
  • Speech Sound Disorders

Keywords

  • Speech Therapy
  • Motor Speech Disorder
  • Childhood Apraxia of Speech
  • Verbal Dyspraxia
  • Ultrasound Biofeedback
03

In context

Apraxias

65 studies on the registry are indexed under Apraxias; 21 are open to participants now.

This study's planned enrollment of 20 is below the median of 32 across 50 interventional studies indexed under Apraxias.

Browse Apraxias studies →

Lead sponsor

Aline Mara de Oliveira is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 27, 2026. See what changed

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Clinical diagnosis of Childhood Apraxia of Speech (CAS) confirmed by assessment; Age between 5 and 12 years; Monolingual speakers of Brazilian Portuguese; Normal auditory, cognitive, and receptive language skills; Normal results on orofacial screenings.

Exclusion criteria

Exclusion criteria:

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Behavioral: Ultrasound Visual Feedback

    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.

    Behavioral: Ultrasound Visual Feedback

  • Active comparator
    Waiting list

    Waiting list that will receive treatment only after the research is completed

    Other: Waitlist

Interventions

  • BehavioralUltrasound Visual Feedback

    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.

  • OtherWaitlist

    Waitlist patients who will receive the intervention after the study concludes.

06

What researchers measure

Primary outcomes

  1. 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;

    Time frame: Assessed at follow-up, 4 weeks after final therapy session.

07

Study locations

1 of 1 sites recruiting
  • Prof. Dr. Aline Mara de Oliveira
    Florianópolis, Santa Catarina 88085-174, Brazil
    Recruiting
08

References and documents

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 39651790 ↗
  • McCabe 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

2 registry updates since Sep 25, 2026
Eligibility
Maximum age 16 Years→12 Years; 1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedClinical diagnosis of Childhood Apraxia of Speech (CAS) confirmed by assessment; Age between 5 and 1612 years; Monolingual speakers of Brazilian Portuguese; Normal auditory, cognitive, and receptive language skills; Normal results on orofacial screenings.
across 2 updates, Oct 19, 2026 – Oct 27, 2026
Interventions
Added Waitlist; removed Behavioral: Traditional Speech Therapy
Oct 19, 2026
Show all 2 updates
  1. Oct 27, 2026
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedClinical diagnosis of Childhood Apraxia of Speech (CAS) confirmed by assessment; Age between 5 and 1612 years; Monolingual speakers of Brazilian Portuguese; Normal auditory, cognitive, and receptive language skills; Normal results on orofacial screenings.
  2. Oct 19, 2026
    Eligibility Maximum age 16 Years→12 Years
    Interventions Added Waitlist; removed Behavioral: Traditional Speech Therapy
    + 3 other changes: index terms, identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07087249
Lead sponsor
Aline Mara de Oliveira
Responsible party
Aline Mara de Oliveira (Principal Investigator, Santa Catarina Federal University) — Sponsor-investigator
First posted
Jul 25, 2025
Start date
Apr 1, 2026
Primary completion
Oct 1, 2027 (estimated)
Completion
Jan 20, 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Aline Oliveira, Dr
Contact
aline.mara.oliveira@ufsc.br
+447886206892

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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