Cerebral PalsyNCT07784790
Speech Therapy Settings in Cerebral Palsy
A study testing Hospital-based Speech and Language Therapy and Home-based Speech and Language Therapy in people with Cerebral Palsy, run by Selcuk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Hospital-based Speech and Language Therapy and Home-based Speech and Language Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Severe epileptic seizures
- Presence of another neurological or psychiatric disorder
- Inability to obtain written parental consent or ensure regular follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Hospital-based and Home-based Speech and Language Therapy in Patients With 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.
- Conditions
- Cerebral Palsy
- Being tested
- Hospital-based Speech and Language Therapy, Home-based Speech and Language Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-based Speech and Language TherapyBehavioural
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 TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based Therapy | Experimental | Participants will receive professional speech and language therapy in a hospital setting, provided by trained speech-language therapists. Receives: 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. Receives: Behavioral: Home-based Speech and Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi AKYILDIZ TEZCAN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784790
- Sponsor's protocol ID
- 2025/324
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared outside the study team because no external data-sharing plan has been established for this study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hospital-based and Home-based Speech and Language Therapy in Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07784790
- Acronym / sponsor ID
- 2025/324
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospital-based Therapy | Experimental | Behavioral: Hospital-based Speech and Language TherapyParticipants will receive professional speech and language therapy in a hospital setting, provided by trained speech-language therapists. |
| Home-based Therapy | Active comparator | Behavioral: Home-based Speech and Language TherapyParticipants will receive speech and language therapy at home, guided by parents who are instructed and supervised remotely by a speech-language therapist. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Severe epileptic seizures
- Presence of another neurological or psychiatric disorder
- Inability to obtain written parental consent or ensure regular follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital-based Speech and Language TherapyParticipants will attend individual speech and language therapy sessions conducted by a professional speech-language therapist in a hospital setting. | Behavioural | Hospital-based Therapy |
| Home-based Speech and Language TherapyParents will administer a structured speech and language intervention at home following a therapy program provided and supervised remotely by a professional speech-language therapist. | Behavioural | Home-based Therapy |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared outside the study team because no external data-sharing plan has been established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital-based Speech and Language Therapy and Home-based Speech and Language Therapy in people with Cerebral Palsy, run by Selcuk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ezgi AKYILDIZ TEZCAN, Assistant Professor (+90332 241 50 00, drezgiakyildiz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.