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Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Sponsor: Aline Mara de Oliveira
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.
Key Details
Gender
All
Age Range
5 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-04-01
Completion Date
2028-01-20
Last Updated
2026-09-23
Healthy Volunteers
No
Interventions
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.
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).
Locations (1)
Prof. Dr. Aline Mara de Oliveira
Florianópolis, Santa Catarina, Brazil