跳至主要内容
临床试验/NCT07087249
NCT07087249尚未招募不适用

Efficacy of Ultrasound Biofeedback in Brazilian Childhood Apraxia of Speech: A Randomized Clinical Trial

Aline Mara de Oliveira2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
2
主要终点
Percentage of Correct Consonants (PCC)

研究概览

简要总结

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.

详细描述

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 (Conventional Motor-Based Therapy): The control group receives an intensive motor-based speech therapy program of equal dose and duration, but without ultrasound visual feedback. This conventional therapy is grounded in established motor learning principles for CAS, focusing on repetitive practice of speech targets with gradually increasing difficulty and strategic feedback. Children in the control group practice the same type of target sounds and words as the experimental group (described below under "Therapy Targets and Sessions"). The key difference is that the clinician uses standard cueing techniques instead of instrumented biofeedback: for example, verbal descriptions of tongue placement ("Put your tongue tip behind your teeth for /t/"), visual cues (watching the clinician's mouth, using a mirror), tactile prompts, and knowledge of results feedback (indicating whether the attempt was correct or not). Both groups therefore receive high-intensity, drill-based practice and employ principles of motor learning (such as frequent practice, feedback, and gradually reduced cueing), but the experimental group gains extra visual feedback about tongue movements, whereas the control relies on traditional auditory-proprioceptive feedback only. This distinction reflects different motor learning approaches: the ultrasound provides immediate internal feedback on articulator movement, while the control approach emphasizes outcomes (sound correctness) without direct internal visual feedback.

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.). Both groups practice a similar set of target stimuli (words or pseudowords containing these phonemes in different syllabic contexts), chosen to facilitate motor planning and to allow measurement of generalization to unpracticed words. Each participant undergoes a series of therapy sessions over the course of the intervention. Sessions are typically scheduled multiple times per week (e.g. 2 sessions per week) for several weeks, to accumulate a high dose of practice trials. Each session lasts about 45-60 minutes, structured into two phases: an ultrasound-assisted phase and an unassisted phase. In the experimental group's sessions, roughly the first half of the session is the ultrasound-assisted practice. During this phase (approximately 20-30 minutes), the child practices the target sounds/words while viewing the real-time ultrasound display of their tongue. The clinician might use 8-10 target words per session, training each multiple times. The child is encouraged to adjust their articulations by watching the tongue image (for example, ensuring the tongue shape reaches a certain height or contact for a sound) and by following the clinician's live feedback on the screen. In the second half of the session, the ultrasound machine is turned off (or the screen is hidden) for the unassisted practice phase, which also lasts about 20-30 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Only the person assessing post-treatment outcomes will be blinded to group allocation.

入排标准

年龄范围
5 Years 至 16 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Percentage of Correct Consonants (PCC)

时间窗: 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;

次要结局

未报告次要终点

研究者

发起方
Aline Mara de Oliveira
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aline Mara de Oliveira

Principal Investigator

Santa Catarina Federal University

研究点 (2)

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