Communication in Children With or Without Biomedical Conditions: Speech and Language Profile, Related Outcomes and Articulation Treatment With Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 20-item probe list accuracy
研究概览
简要总结
This prospective randomized controlled trial investigates the effect of ultrasound visual biofeedback as an adjunct to articulation therapy in children with speech sound disorders involving lingual targets. The intervention aims to facilitate acquisition of misarticulated sounds by providing real-time visualization of tongue movements. Participants are randomized 1:1 to immediate treatment or wait-list control, with stratification by disorder type, age, and gender where feasible. The wait-list control group continues usual care for 4 weeks before crossing over to receive the same intervention (ethical crossover design).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of speech sound disorder with errors on lingual target sounds
- •Probe accuracy <70% on the primary target sound at baseline
- •Cantonese as the first language
- •Hearing thresholds ≤25 dB in at least one ear, with no hearing loss exceeding 50 dB in the other ear
- •No syndromes or obvious dysmorphic features
- •No language disorders associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
- •No oronasal fistula identified on oral examination or diagnosed velopharyngeal insufficiency
排除标准
- •Presence of syndromes or dysmorphic features
- •Language disorder associated with biomedical conditions (e.g., cerebral palsy, autism spectrum disorder)
- •Hearing thresholds >25 dB in one ear and >50 dB in the other ear Planned surgical intervention during the study period
研究组 & 干预措施
Immediate treatment group
Ultrasound-aided articulation therapy
干预措施: Ultrasound-aided articulation therapy (Behavioral)
Wait-list Control Group
No treatment for 4 weeks, and later having the same ultrasound-aided articulation therapy as immediate treatment group
结局指标
主要结局
20-item probe list accuracy
时间窗: Week0, Week4, Week8, Week16
Perceptual accuracy on an individualized 20-item target sound probe spanning varying linguistic levels (single words to narrative), reported in percentage.
次要结局
- Intelligibility in Context Scale (ICS): Traditional Chinese(Week1, Week 8, Week 16)
- Percentage Consonants Correct (PCC)(Week0, Week 16)
- PedsQL TM (Pediatric Quality of Life Inventory TM)(Week 0, Week 8,Week 16)
- Strengths and Difficulties Questionnaire (SDQ)(Week 0, Week 8, Week16)
- Parental Stress Scale (PSS)(Week0, Week 8, Week 16)
研究者
Yiu Oi Yan
Principal Investigator
The University of Hong Kong