The Effect of Tomatis Auditory Stimulation in Children and Adolescent With Neurodevelopmental Disorders (TomatisOn)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Air conduction thresholds
研究概览
简要总结
The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.
详细描述
This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with Neurodevelopmental Disorders referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- neurodevelopmental disorder
排除标准
- •intellectual disability
结局指标
主要结局
Air conduction thresholds
时间窗: Change from baseline AC (time 0) at immediately after the intervention (time 1)
% Spatialization errors in air conduction
Bone conduction thresholds
时间窗: Change from baseline BC(time 0) at immediately after the intervention (time 1)
% Spatialization errors in Bone conduction
次要结局
- Developmental Disability Children's Global Assesment Scale total score(Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1))
研究者
Andeea Robe
Principal Investigator
Babes-Bolyai University