Clinical trial NCT06827743: Feeding Behavior Intervention in Children with Cerebral Visual Impairment
Official title: Effectiveness of Feeding Intervention on Feeding Behavior, Developmental Areass and Sensory Processing in Children with Cerebral Visual Impairment and Cerebral Palsy: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Sensory Integration Disorder
Cerebral Visual Impairment
Keywords: Feeding Behavior
Sensory Integration Disorder
Cerebral Visual Impairment
Cerebral palsy
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled intervention trial
Primary purpose: TREATMENT

Brief summary: This study was planned to investigate the effects of nutritional education given in addition to sensory integration intervention on feeding behavior, sensory processing and developmental areas in children with Cerebral Visual Impairment (CVI) and Cerebral Palsy (CP). Children with CVI and CP were randomly divided into two groups. Sensory integration education was applied to both groups and additional feeding behavior education was applied to one group. The development in feeding behavior and sensory processing was analyzed before and after the intervention.

Detailed description: This study was planned to investigate the effects of feeding education given in addition to sensory integration intervention on feeding behavior, sensory processing and developmental areas in children with CVI and CP. Children with CVI and CP aged 46-60 months were randomly divided into two groups. Sensory integration training was applied to both groups and additional feeding behavior training was applied to 1 group. Before and after the intervention, children's feeding behavior was evaluated with the Behavioral Pediatric Feeding Assessment Scale and sensory processing skills with the Dunn Sensory Profile. The interventions were applied 3 days a week for 12 weeks. Intervention details are as follows.

The duration and protocol of the training were designed by referring to previous studies. The training program includes sensory integration and feeding behavior training. Both the control and study groups will receive 2 sessions of sensory integration-based feeding training of 40 minutes per week for 12 weeks. The study group will receive 2 sessions of feeding behavior training of 40 minutes per week in addition to sensory integration training for 12 weeks. The sensory integration training given to both groups includes training that includes oral processing skills in particular, as well as training that includes tactile, vestibular, proprioception and visual stimuli when needed. The child will be supported with sensory stimuli to ensure that they focus and remain calm. Sensory integration training will be planned considering the Dunn Sensory Profile test results. In this training, different patterned fabrics, plush and toys with different surfaces for tactile stimulation to ensure the child's calmness and focus; swings and exercise balls for vestibular stimulation; and training to provide sensory regulation with proprioceptive approaches will be provided. In addition, within the scope of sensory integration training, stimuli will be given to the oral region according to the children's sensory responses to the texture, taste and content of foods. In addition, oral sensory integration training will be given with sensory stimuli for chewing problems. Two groups will receive personalized sensory integration training, while one group will receive feeding behavior training. Both the caregiver and the child will participate in the feeding behavior training. In order for the training to be successful, the therapist, the child and the parent must cooperate. Before this training, children will be evaluated with the Behavioral Pediatric Feeding Assessment Scale and a behavioral training plan will be created according to the children's attitudes and behaviors during feeding. This plan will include organizing feeding times, determining the families' approach to the child's behavior during feeding, organizing the children's feeding behavior problems with extinguishing and desensitization methods, and organizing the feeding environment. The sensory integration training room was designed according to Parham's sensory integration therapy principles. An individualized sensory integration training based on the basic principles of sensory integration therapy developed by Parham will be applied. According to the evaluations in the individualized program, the baby's problem areas are determined and training is planned in line with certain principles regarding the problem areas. These principles are as follows: Providing sensory opportunities, revealing problem areas, avoiding negative experiences, cooperating in activity choices, helping self-organization, supporting with optimum stimuli, creating a play environment, maximizing the child's success, ensuring physical safety and organizing the child's life within the play environment and ensuring alliance during treatment. All training will be delivered individually, face to face, in therapy rooms in accordance with the sensory integration room plan.

Eligibility criteria: Inclusion Criteria:

* • Children with Cerebral Palsy Diagnosed with Cerebral Visual Impairment in Hospital Report

  * Between the ages of 48-72,
  * Having been diagnosed with cerebral palsy.
  * Having a feeding problem according to the results of the behavioral pediatric feeding assessment scale
  * Individuals who volunteer to participate in the study and read and signed the informed consent form by their parents will be included in the study.

Exclusion Criteria:

* Not accepting to participate in the study.

  * Not having any serious sensory loss other than vision problems. (According to the hospital report)
  * Having had any surgery in the last 6 months.
  * Having had very frequent epileptic seizures

Primary outcomes:
measure: Behavioral Pediatric Feeding Assessment Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Dunn Sensory Profile
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Special Education Center
Study officials:
References:
citation: Erol, N., N. Sezgin, and I. Savaşır, Validity studies on Ankara Development Screening Inventory. Turkish Journal of Psychology, 1993. 29(8): p. 16-22.
citation: Onal, S., E.Ç. Var, and A. Uçar, Adaptation study of the Behavioral Pediatric Feeding Assessment Scale (BPFAS) to Turkish. Nevşehir Science and Technology Journal, 2017. 6(1): p. 93-101.
citation: Kayihan H, Akel BS, Salar S, Huri M, Karahan S, Turker D, Korkem D. DEVELOPMENT OF A TURKISH VERSION OF THE SENSORY PROFILE: TRANSLATION, CROSS-CULTURAL ADAPTATION, AND PSYCHOMETRIC VALIDATION. Percept Mot Skills. 2015 Jun;120(3):971-86. doi: 10.2466/08.27.PMS.120v17x8. Epub 2015 Jun 9.
citation: Dunn, W., Sensory profile. PsycTESTS Dataset, 1999.
citation: Lehman, S.S., Cortical Visual Impairment in the Child with Cerebral Palsy. Cerebral Palsy, 2020: p. 1049-1055.