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

NCT07087249 | Recruiting DMC

• 1 other identifier: 09476918.5.0000.0121
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood Apraxia of Speech; Speech Sound Disorders

Keywords

Speech Therapy; Motor Speech Disorder; Childhood Apraxia of Speech; Verbal Dyspraxia; Ultrasound Biofeedback

Outcome Measures

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;

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

Study Arms (2)

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.

Behavioral: Ultrasound Visual Feedback

Waiting list

ACTIVE COMPARATOR

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

Behavioral: Traditional Speech Therapy

Interventions

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.

Behavioral: Ultrasound Visual Feedback

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).

Waiting list

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aline Mara de Oliveira: lead

Study Sites (1)

Prof. Dr. Aline Mara de Oliveira

Florianópolis, Santa Catarina, 88085-174, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 39651790 RESULT

• 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.

  PMID: 36848673 RESULT

MeSH Terms

Conditions

Apraxias; Speech Sound Disorder; Communication Disorders

Condition Hierarchy (Ancestors)

Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Aline Oliveira, Dr

CONTACT

+447886206892; aline.mara.oliveira@ufsc.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person evaluating the post-treatment results will remain blinded to group allocation. The person performing the group randomization will as well.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel arms: (1) experimental group with ultrasound visual biofeedback; (2) control group (waitlist).

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 25, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 20, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)