Home-Based Action Observation Training for Chewing and Swallowing Function

NCT06268223 | Completed

• 1 other identifier: 2023/315
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Pediatric Evaluation of Disability Inventory

  Up to 12 Weeks

• Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL CP Module)

  Up to 12 weeks

• Turkish version of the Feeding/Swallowing Impact Survey (T-FS-IS)

  Up to 12 week

Study Arms (2)

Study Group

EXPERIMENTAL

Other: Functional Chewing Exercise; Other: Action Observation Training

Control Group

ACTIVE COMPARATOR

Other: Functional Chewing Exercise

Interventions

Functional Chewing Exercise OTHER

Functional Chewing Exercise, consisting of 5 sets per day, 5 days a week, for 12 weeks.

Control Group; Study Group

Action Observation Training OTHER

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Seda Nur Kemer,PT, MSc,PhD Candidate, Lecturer

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Academic Lecturer

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 20, 2024
• Study Start: March 13, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 11, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)