Cerebral Palsy
Conditions
Brief 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. 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.
Interventions
OTHERFunctional Chewing Exercise
Functional Chewing Exercise, consisting of 5 sets per day, 5 days a week, for 12 weeks.
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.
Sponsors
Ondokuz Mayıs University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Karaduman Chewing Performance Scale | 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 | 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 | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Evaluation of Disability Inventory | Up to 12 Weeks | 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. |
| Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module) | Up to 12 weeks | 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 |
| Turkish version of the Feeding/Swallowing Impact Survey (T-FS-IS) | Up to 12 week | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed