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NCT Number: NCT06268223

Home-Based Action Observation Training for Chewing and Swallowing Function

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Samsun, Atakum, 55200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Chewing Exercise

Other

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Pediatric Evaluation of Disability Inventory

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

The Effect of Home-Based Action Observation Training on Chewing and Swallowing Function in Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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