Speech Therapy Settings in Cerebral Palsy

NCT07784790 | Not Yet Recruiting

• 1 other identifier: 2025/324
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline (Month 0) and Month 6 after start of therapy

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

  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.

  Baseline and Month 6

Study Arms (2)

Hospital-based Therapy

EXPERIMENTAL

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

Behavioral: Hospital-based Speech and Language Therapy

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.

Behavioral: Home-based Speech and Language Therapy

Interventions

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.

Hospital-based Therapy

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.

Home-based Therapy

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Central Study Contacts

Ezgi AKYILDIZ TEZCAN, Assistant Professor

CONTACT

+90332 241 50 00; drezgiakyildiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: August 25, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share