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NCT Number: NCT07784790

Speech Therapy Settings in Cerebral Palsy

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.

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Key information

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Hospital-based Speech and Language Therapy

Behavioral

Participants will attend individual speech and language therapy sessions conducted by a professional speech-language therapist in a hospital setting.

Home-based Speech and Language Therapy

Behavioral

Parents will administer a structured speech and language intervention at home following a therapy program provided and supervised remotely by a professional speech-language therapist.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ezgi AKYILDIZ TEZCAN, Assistant Professor

CONTACT

[email protected]

+90332 241 50 00

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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