Efficacy of Ultrasound Biofeedback in Brazilian Childhood Apraxia of Speech

NCT07087249 | Not Yet Recruiting DMC

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

Brief Summary

This study is a single-blind, randomized controlled trial evaluating the efficacy of ultrasound visual biofeedback (UVB) in the treatment of Childhood Apraxia of Speech (CAS) among Brazilian children. Approximately half of the participants are randomly assigned to an Experimental group receiving the ultrasound biofeedback intervention, and the other half to a Control group receiving conventional motor-based therapy without ultrasound. Randomization is performed using a computer-generated sequence (allocation ratio 1:1), with allocation concealment (e.g. sealed opaque envelopes) to prevent selection bias. Blinding is maintained for outcome assessment: an independent speech-language pathologist who is masked to group assignment will evaluate pre- and post-therapy speech samples for all children. Neither the therapists nor the participants are blinded (due to the nature of the intervention), but the use of blinded outcome evaluators helps ensure objective assessment.

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

Behavioral: Traditional Speech Therapy

ACTIVE COMPARATOR

Speech therapy for children with Childhood Apraxia of Speech (CAS), based on motor learning principles. Sessions are delivered twice per week over six weeks (12 total).

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).

Behavioral: Traditional Speech Therapy

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of Childhood Apraxia of Speech (CAS) confirmed by at least two certified speech-language pathologists; Aged between 5 and 16 years; Monolingual Brazilian Portuguese speakers; Normal hearing, cognitive, and receptive language skills; Normal results on oral-facial and non-verbal intelligence 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 developmental disorders Bilingual speakers or those 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

Location

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 BACKGROUND

• 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 BACKGROUND

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: Only the person assessing post-treatment outcomes will be blinded to group allocation.
• 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 with traditional speech therapy.

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 25, 2025
• Study Start: August 6, 2025
• Primary Completion: September 1, 2025
• Study Completion: January 15, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)