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临床试验/NCT07784790
NCT07784790尚未招募不适用

Comparison of Hospital-based and Home-based Speech and Language Therapy in Patients With Cerebral Palsy

Selcuk University0 个研究点目标入组 52 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
主要终点
Change in Functional Outcome in Communication Under Six (FOCUS-34) Total Score

研究概览

简要总结

Cerebral palsy (CP) is a common neurodevelopmental disorder affecting motor functions, cognition, and communication skills in children. Speech and language delays are prevalent among children with CP, significantly impacting their social interactions and daily life activities. This study aims to compare the effectiveness of hospital-based professional speech and language therapy with home-based parent-guided interventions for language development in children aged 18-36 months with CP. Participants will be assessed at baseline and after 6 months using standardized tools measuring motor functions, manual abilities, communication skills, and functional independence. The study will provide valuable insights into optimizing therapeutic approaches for language and communication development in children with CP.

研究设计

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

入排标准

年龄范围
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of cerebral palsy
  • Age between 18 and 36 months
  • Hearing loss of less than 50 dB
  • No severe visual impairment that cannot be corrected with eyeglasses
  • Ability to understand simple verbal instructions
  • Written informed consent from a parent or legal guardian

排除标准

  • Severe epileptic seizures
  • Presence of another neurological or psychiatric disorder
  • Inability to obtain written parental consent or ensure regular follow-up

研究组 & 干预措施

Hospital-based Therapy

Experimental

Participants will receive professional speech and language therapy in a hospital setting, provided by trained speech-language therapists.

干预措施: Hospital-based Speech and Language Therapy (Behavioral)

Home-based Therapy

Active Comparator

Participants will receive speech and language therapy at home, guided by parents who are instructed and supervised remotely by a speech-language therapist.

干预措施: Home-based Speech and Language Therapy (Behavioral)

结局指标

主要结局

Change in Functional Outcome in Communication Under Six (FOCUS-34) Total Score

时间窗: Baseline (Month 0) and Month 6 after start of therapy

The FOCUS-34 questionnaire contains 34 parent-reported items scored 1 = "never" to 7 = "always." Total score range = 34 - 238 points. Higher scores indicate better communicative participation. The change score will be calculated as Month 6 minus Baseline.

Change in Turkish Communicative Development Inventory (TIGE) Expressive Vocabulary Raw Score

时间窗: Baseline and Month 6

TIGE is the Turkish adaptation of the MacArthur-Bates Communicative Development Inventories. The Expressive Vocabulary sub-scale counts the number of words the child can produce; range = 0 - 711 words. Higher scores represent better expressive language. Change = Month 6 minus Baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi AKYILDIZ TEZCAN

assistant professor

Selcuk University

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