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Efficacy of Ultrasound Biofeedback in Brazilian Childhood Apraxia of Speech

NCT07087249 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

Ultrasound 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.

BEHAVIORAL

Traditional Speech Therapy

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).

Sponsors & Collaborators

  • Aline Mara de Oliveira

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-06
Primary Completion
2025-09-01
Completion
2026-01-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07087249 on ClinicalTrials.gov