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Effects of an oral feeding rehabilitation program on oropharyngeal dysphagia in children with cerebral palsy and children at high risk of cerebral palsy in resource-limited Thai healthcare settings

Effects of an oral feeding rehabilitation program on oropharyngeal dysphagia in children with cerebral palsy and children at high risk of cerebral palsy in resource-limited Thai healthcare settings

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251102004
Enrollment
20
Registered
2025-11-02
Start date
2025-11-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal dysphagia Cerebral palsy High-risk infants for cerebral palsy Feeding disorder Malnutrition Aspiration pneumonia Deglutition Disorders Cerebral Palsy Infant, High-Risk Feeding Behavior Rehabilitation Oral Motor Function Telemedicine Quality of Life Caregivers Thailand

Interventions

Participants in this group will receive the Oral Feeding Rehabilitation Program(OFRP), consisting of 12 sessions over 12 weeks (1 session per week, 45-60 minutes each). The intervention includes oral
Experimental Other,Active Comparator Other
Hospital-based,Home-based

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Months to 5 Years

Inclusion criteria

Inclusion criteria: 1. Children aged between 3 months and 5 years at the time of enrollment. 2. Diagnosed with cerebral palsy (CP) or identified as high risk for CP based on clinical history and abnormal HINE scores. 3. Present with oromotor dysfunction (e.g., drooling, swallowing, or sucking difficulties). 4. Able to participate in scheduled training sessions and follow-up assessments. 5. Caregivers can perform home training daily for 12 weeks and participate via telemedicine (LINE video call) when required. 6. Written informed consent obtained from caregivers or legal guardians.

Exclusion criteria

Exclusion criteria: 1. Dysphagia due to cardiac, respiratory, or gastrointestinal disorders. 2. Unstable respiratory symptoms (e.g., dyspnea, desaturation, excessive secretions). 3. Structural anomalies affecting feeding (e.g., cleft lip or palate). 4. Uncontrolled seizures. 5. Caregivers with cognitive or communication impairments that affect understanding of the program or questionnaire completion.

Design outcomes

Primary

MeasureTime frame
Functional Oral Intake Scale (FOIS) / Functional Oral Intake Scale for Infants (FOISi) Baseline and 12 weeks Change in FOIS or FOISi score between baseline and week 12

Secondary

MeasureTime frame
Oral Motor Assessment Scale (OMAS) Baseline and 12 weeks Change in OMAS score between baseline and week 12,Penetration Aspiration Scale (PAS) Baseline and 12 weeks Change in PAS score between baseline and week 12,International Dysphagia Diet Standardisation Initiative (IDDSI) level Baseline and 12 weeks Change in IDDSI level between baseline and week 12,Percentile of predicted weight-for-age according to WHO growth standards Baseline and 12 weeks Change in Percentile of predicted weight-for-age according to WHO growth standards between baseline and week 12, WHOQOL-BREF-THAI score Baseline and 12 weeks Change in WHOQOL-BREF-THAI score between baseline and week 12

Countries

Thailand

Contacts

Public ContactCHALIDA KARNJANASIRIRAT

Faculty of Medicine Siriraj Hospital, Mahidol University

Chalida.kar@student.mahidol.ac.th024197508

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026