Home-Based Action Observation Training for Chewing and Swallowing Function

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.

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 Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Functional Chewing Exercise; Other: Action Observation Training

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Atakum
    • Samsun, Atakum, Turkey (Türkiye), 55200
      • Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Other: Functional Chewing Exercise; Functional Chewing Exercise, consisting of 5 sets per day, 5 days a week, for 12 weeks.
Experimental: Study Group	Other: Functional Chewing Exercise; Functional Chewing Exercise, consisting of 5 sets per day, 5 days a week, for 12 weeks.; Other: Action Observation Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Up to 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	Up to 12 week

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Collaborators: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Actual): March 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2023/315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No