Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Correct Consonants (PCC)
研究概览
简要总结
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.
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:
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.). Control Intervention (Waitlist): The control group will not receive the intervention during the study; they will only be monitored via assessments. This group will receive the intervention at the end of the study.
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
The person evaluating the post-treatment results will remain blinded to group allocation. The person performing the group randomization will as well.
入排标准
- 年龄范围
- 5 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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 development disorders; Bilingual speakers or individuals exposed to other languages at home.
研究组 & 干预措施
Behavioral: Ultrasound Visual Feedback
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.
干预措施: Ultrasound Visual Feedback (Behavioral)
Waiting list
Waiting list that will receive treatment only after the research is completed
干预措施: Traditional Speech Therapy (Behavioral)
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
Aline Mara de Oliveira
Principal Investigator
Santa Catarina Federal University
