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临床试验/NCT06105099
NCT06105099招募中不适用

One Size Does Not Fit All: From a Common Approach Towards Performance-specific Speech Intervention and Long-term Learning in Children With a Cleft Palate

University Ghent1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
135
试验地点
1
主要终点
Consonant proficiency

研究概览

简要总结

Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project.

The first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs.

The second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective.

This proposal will improve evidence-based and patient-tailored cleft speech therapy.

详细描述

Objective 1: To compare the (immediate) effect of three speech therapy approaches (i.e.

a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and health-related quality of life (HRQoL) in Belgian Dutch-speaking children with a CP±L and different subtypes of compensatory CSCs (anterior oral CSCs, posterior oral CSCs, or non-oral CSCs) measured by perceptual and psychosocial outcome measures.

Objective 2: To measure the short-term effects (performance to learning) and the long-term learning effects (retention and transfer) of the three different speech therapy approaches (i.e. a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and HRQoL in Belgian Dutch-speaking children with a CP±L and different subtypes of compensatory CSCs measured by perceptual and psychosocial outcome measures.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Belgian Dutch-speaking children with a cleft palate with or without a cleft lip
  • •Aged between 4 and 12 years
  • •Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist

排除标准

  • •Children with syndromic clefts
  • •Oronasal fistula
  • •Velopharyngeal insufficiency
  • •Hearing disabilities based on pure tone audiometry (>25 dB HL)
  • •Cognitive and/or related learning disabilities or neuromuscular disorders

研究组 & 干预措施

Children with anterior oral cleft speech characteristics

Active Comparator

To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.

干预措施: Phonological intervention (Behavioral)

Children with anterior oral cleft speech characteristics

Active Comparator

To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.

干预措施: Combined phonetic-phonological intervention (Behavioral)

Children with anterior oral cleft speech characteristics

Active Comparator

To investigate the best speech therapy approach for children with anterior oral cleft speech characteristics, we will provide three different interventions.

干预措施: Motor-phonetic intervention (Behavioral)

Children with posterior oral cleft speech characteristics

Experimental

To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.

干预措施: Motor-phonetic intervention (Behavioral)

Children with posterior oral cleft speech characteristics

Experimental

To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.

干预措施: Phonological intervention (Behavioral)

Children with posterior oral cleft speech characteristics

Experimental

To investigate the best speech therapy approach for children with potserior oral cleft speech characteristics, we will provide three different interventions.

干预措施: Combined phonetic-phonological intervention (Behavioral)

Children with non-oral cleft speech characteristics

Experimental

To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.

干预措施: Motor-phonetic intervention (Behavioral)

Children with non-oral cleft speech characteristics

Experimental

To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.

干预措施: Phonological intervention (Behavioral)

Children with non-oral cleft speech characteristics

Experimental

To investigate the best speech therapy approach for children with non-oral cleft speech characteristics, we will provide three different interventions.

干预措施: Combined phonetic-phonological intervention (Behavioral)

结局指标

主要结局

Consonant proficiency

时间窗: Assessment at 6 months post-intervention

Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

Consonant proficiency

时间窗: Assessment immediately pre-intervention

Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

Consonant proficiency

时间窗: Assessment immediately post-intervention

Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

Consonant proficiency

时间窗: Assessment at 1 month post-intervention

Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

Consonant proficiency

时间窗: Assessment at 3 months post-intervention

Consonant proficiency will be measured in terms of percentage correctly produced consonants (%)

次要结局

  • Intelligibility in Context(Assessment at 6 months post-intervention)
  • Health-related quality of life(Assessment at 6 months post-intervention)
  • Intelligibility in Context(Assessment immediately pre-intervention)
  • Intelligibility in Context(Assessment immediately post-intervention)
  • Intelligibility in Context(Assessment at 1 month post-intervention)
  • Intelligibility in Context(Assessment at 3 months post-intervention)
  • Health-related quality of life(Assessment immediately pre-intervention)
  • Health-related quality of life(Assessment immediately post-intervention)
  • Health-related quality of life(Assessment at 1 month post-intervention)
  • Health-related quality of life(Assessment at 3 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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