Clinical trial NCT06268223: Home-Based Action Observation Training for Chewing and Swallowing Function
Official title: The Effect of Home-Based Action Observation Training on Chewing and Swallowing Function in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Chewing Disease
Action Obervation Training
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2024-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:

* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?
* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?
* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study.


Eligibility criteria: 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.

Primary outcomes:
measure: Karaduman Chewing Performance Scale
timeFrame: Up to 12 Weeks
measure: Turkish version of the Mastication Observation and Evaluation Instrument
timeFrame: Up to 12 Weeks
measure: Test of Masticating and Swallowing Solids in Children
timeFrame: Up to 12 Weeks
measure: Nutrient consistency according toInternational Dysphagia Diet Standardisation Initiative
timeFrame: Up to 12 Weeks
measure: The Pediatric version of the Eating Assessment Tool
timeFrame: Up to 12 Weeks
measure: Dysphagia Disorder Survey
timeFrame: Up to 12 Weeks
measure: Behavioral Pediatrics Feeding Assessment Scale
timeFrame: Up to 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer
state: Atakum
Study officials:
References: