Cerebral PalsyNCT06268223
Home-Based Action Observation Training for Chewing and Swallowing Function
A study testing Functional Chewing Exercise and Action Observation Training in people with Cerebral Palsy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study is a two-part randomized controlled trial designed to investigate the effects of home-based Action Observation Training (AOT) combined with Functional Chewing Training (FuCT) in children with Cerebral Palsy (CP) who have chewing disorders. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Functional Chewing Exercise and Action Observation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Cerebral Palsy,
- Age between 6 and 18,
- IQ level of 70 or above,
- Having complaints related to chewing function and inability to manage solid food intake
- Feeding orally.
Who cannot join
- Having a neurodegenerative disease other than Cerebral Palsy
- Having additional chronic illnesses such as systemic diseases, cancer, kidney diseases, gastrointestinal system diseases, etc., that may affect nutritional status,
- Experiencing visual or hearing impairment,
- Using any medication and/or oral device that may affect chewing performance,
- Having received previous chewing and/or swallowing training.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer
Samsun, Atakum, 55200
About this study
Official title: The Effect of Home-Based Action Observation Training on Chewing and Swallowing Function in Children With Cerebral Palsy
This study is a two-part randomized controlled trial designed to investigate the effects of home-based Action Observation Training (AOT) combined with Functional Chewing Training (FuCT) in children with Cerebral Palsy (CP) who have chewing disorders.
In Part I, the primary outcome results-chewing function, swallowing function, and feeding behaviour-will be reported. In Part II, the secondary outcome results, including child participation, quality of life, and caregiver impact, will be presented.
Read more
Within the scope of the study, children with CP will be randomly allocated to either a study group or a control group. Both groups will receive FuCT (5 sets per day, 5 days per week, for 12 weeks). In addition, the study group will participate in a home-based AOT program delivered via telerehabilitation (1 set per day, 3 days per week, for 12 weeks) under the guidance of a physiotherapist.
All participants will be assessed at baseline, at week 6, and at the end of week 12.
- Conditions
- Cerebral Palsy
- Being tested
- Functional Chewing Exercise, Action Observation Training
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Chewing ExerciseOther
Functional Chewing Exercise, consisting of 5 sets per day, 5 days a week, for 12 weeks.
Action Observation TrainingOther
Action Observation Training program, conducted via telerehabilitation, involving 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Not described Receives: Other: Functional Chewing Exercise; Other: Action Observation Training |
| Control Group | Active comparator | Not described Receives: Other: Functional Chewing Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Karaduman Chewing Performance Scale
The Karaduman Chewing Performance Scale is an ordinal scale that is valid, reliable, quick and clinically easy to use to determine the chewing performance level in children with cerebral palsy.
Measured: Up to 12 Weeks
Turkish version of the Mastication Observation and Evaluation Instrument
It is used to evaluate chewing skills.It is a criterion-referenced instrument used to assess individual masticatory skills necessary for efficient intake of solid foods.
Measured: Up to 12 Weeks
Test of Masticating and Swallowing Solids in Children
It is used to quantitatively evaluate the effectiveness of chewing function.This is a norm-referenced, valid and reliable tool for quantitatively assessing the efficiency of masticatory function in children aged 4-18 years.
Measured: Up to 12 Weeks
Dysphagia Disorder Survey (DDS) and Dysphagia Management Staging Scale (DMSS)
DDS is used to evaluate swallowing function. It is a valid and reliable swallowing disorder assessment tool developed and standardised in child and adult populations diagnosed with intellectual and developmental disabilities. It is based on video-recording and observation of a typical meal in which the child consumes foods appropriate to his/her diet.
DMSS is an ordinal scale that classifiesused to classify the severity of dysphagia into five levels based on the DDS score.
Measured: Up to 12 Weeks
Behavioral Pediatrics Feeding Assessment Scale
It is used in the assessment of child feeding behavior. The scale is a 35-question questionnaire that has been culturally adapted and its Turkish validity and reliability have been demonstrated.
Measured: Up to 12 Weeks
Secondary outcomes (3)
Pediatric Evaluation of Disability Inventory
Pediatric Evaluation of Disability Inventory (PEDI) is a standardized assessment tool used to evaluate participation. It measures abilities in three domains: self-care, mobility, and social function. PEDI is commonly used in clinical and research settings to assess functional independence and monitor rehabilitation outcomes.
Measured: Up to 12 Weeks
Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module)
PedsQL Cerebral Palsy Module (PedsQL CP Module) is a condition-specific instrument designed to assess health-related quality of life in children with cerebral palsy. It evaluates CP-related areas such as movement and balance, daily activities, pain, fatigue, eating, and communication
Measured: Up to 12 weeks
Turkish version of the Feeding/Swallowing Impact Survey (T-FS-IS)
T-FS-IS (Turkish Feeding/Swallowing Impact Scale) is a caregiver-reported questionnaire used to assess the impact of feeding and swallowing difficulties on the family.
Measured: Up to 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start13 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Nur Kemer, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268223
- Sponsor's protocol ID
- 2023/315
- Status last verified
- Jun 2025
- First submitted
- 5 Feb 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home-Based Action Observation Training on Chewing and Swallowing Function in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06268223
- Acronym / sponsor ID
- 2023/315
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 20 Feb 2024 (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.
This study is a two-part randomized controlled trial designed to investigate the effects of home-based Action Observation Training (AOT) combined with Functional Chewing Training (FuCT) in children with Cerebral Palsy (CP) who have chewing disorders.
In Part I, the primary outcome results-chewing function, swallowing function, and feeding behaviour-will be reported. In Part II, the secondary outcome results, including child participation, quality of life, and caregiver impact, will be presented.
Within the scope of the study, children with CP will be randomly allocated to either a study group or a control group. Both groups will receive FuCT (5 sets per day, 5 days per week, for 12 weeks). In addition, the study group will participate in a home-based AOT program delivered via telerehabilitation (1 set per day, 3 days per week, for 12 weeks) under the guidance of a physiotherapist.
All participants will be assessed at baseline, at week 6, and at the end of week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Functional Chewing Exercise, Other: Action Observation Training |
| Control Group | Active comparator | Other: Functional Chewing Exercise |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with Cerebral Palsy,
- Age between 6 and 18,
- IQ level of 70 or above,
- Having complaints related to chewing function and inability to manage solid food intake
- Feeding orally.
Key exclusion criteria (5 listed)
- Having a neurodegenerative disease other than Cerebral Palsy
- Having additional chronic illnesses such as systemic diseases, cancer, kidney diseases, gastrointestinal system diseases, etc., that may affect nutritional status,
- Experiencing visual or hearing impairment,
- Using any medication and/or oral device that may affect chewing performance,
- Having received previous chewing and/or swallowing training.
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 |
|---|---|---|
| Functional Chewing ExerciseFunctional Chewing Exercise, consisting of 5 sets per day, 5 days a week, for 12 weeks. | Other | Control Group, Study Group |
| Action Observation TrainingAction Observation Training program, conducted via telerehabilitation, involving 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. | Other | Study Group |
Primary outcome
Karaduman Chewing Performance Scale
Time frame: Up to 12 Weeks
The Karaduman Chewing Performance Scale is an ordinal scale that is valid, reliable, quick and clinically easy to use to determine the chewing performance level in children with cerebral palsy.
Turkish version of the Mastication Observation and Evaluation Instrument
Time frame: Up to 12 Weeks
It is used to evaluate chewing skills.It is a criterion-referenced instrument used to assess individual masticatory skills necessary for efficient intake of solid foods.
Test of Masticating and Swallowing Solids in Children
Time frame: Up to 12 Weeks
It is used to quantitatively evaluate the effectiveness of chewing function.This is a norm-referenced, valid and reliable tool for quantitatively assessing the efficiency of masticatory function in children aged 4-18 years.
Dysphagia Disorder Survey (DDS) and Dysphagia Management Staging Scale (DMSS)
Time frame: Up to 12 Weeks
DDS is used to evaluate swallowing function. It is a valid and reliable swallowing disorder assessment tool developed and standardised in child and adult populations diagnosed with intellectual and developmental disabilities. It is based on video-recording and observation of a typical meal in which the child consumes foods appropriate to his/her diet. DMSS is an ordinal scale that classifiesused to classify the severity of dysphagia into five levels based on the DDS score.
Behavioral Pediatrics Feeding Assessment Scale
Time frame: Up to 12 Weeks
It is used in the assessment of child feeding behavior. The scale is a 35-question questionnaire that has been culturally adapted and its Turkish validity and reliability have been demonstrated.
3 secondary outcomes
Pediatric Evaluation of Disability Inventory
Time frame: Up to 12 Weeks
Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module)
Time frame: Up to 12 weeks
Turkish version of the Feeding/Swallowing Impact Survey (T-FS-IS)
Time frame: Up to 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Chewing Exercise and Action Observation Training in people with Cerebral Palsy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karaduman Chewing Performance Scale (time frame: Up to 12 Weeks). The study lists 5 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 11 Mar 2026.