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NCT Number: NCT07087249

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

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.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Aline Mara de Oliveira

Florianópolis, Santa Catarina, 88085-174, Brazil

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

Treatment and study plan

Ultrasound visual feedback

Behavioral

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.

Traditional Speech Therapy

Behavioral

Standard speech motor therapy for children with Childhood Apraxia of Speech (CAS), based on evidence-based motor learning approaches. No visual feedback tools are used. Therapy focuses on blocked and random practice, varied feedback, and increasing speech complexity. Delivered in 12 sessions over 6 weeks (twice per week).

Primary outcomes

  1. Percentage of Correct Consonants (PCC)

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

    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;

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Sponsors and collaborators

Lead sponsor

Aline Mara de Oliveira

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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