NCT06827743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

1.1 years

First QC Date

February 8, 2025

Last Update Submit

February 13, 2025

Conditions

Keywords

Feeding BehaviorSensory Integration DisorderCerebral Visual ImpairmentCerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Behavioral Pediatric Feeding Assessment Scale

    The Behavioral Pediatric Feeding Assessment Scale, developed by Crist and colleagues, is a 5-point Likert-type scale. The statements in the scale consisting of 25 questions are scored between 1 and 5 (1=Never, 2=Rarely, 3=Sometimes, 4=Frequently, 5=Always). The scores to be obtained from the scale vary between 35-175, and an increase in the obtained score indicates a highly problematic eating disorder and eating habits. The scale consists of four sub-dimensions. There are 7 items in the food selectivity sub-dimension, 5 items in the early food refusal sub-dimension, 5 items in the early lumpy food refusal sub-dimension, and 7 items in the late food refusal sub-dimension. A total score above 84 on the scale or more than 9 problems indicates an eating behavior problem. The Turkish validity and reliability study of the scale was conducted by Önal and colleagues. Cronbach's α value was found to be 0.88.

    12 weeks

Secondary Outcomes (1)

  • Dunn Sensory Profile

    12 weeks

Study Arms (2)

Cerebral visual impairment intervention group

EXPERIMENTAL

In addition to sensory integration training, nutritional behavior training will be given to this group.

Behavioral: feeding behavior educationBehavioral: Sensory integration intervention

Ceerbral visual impairment children (control group)

ACTIVE COMPARATOR

Only sensory integration training will be given to this group.

Behavioral: Sensory integration intervention

Interventions

Two groups will receive personalized sensory integration training, and one group will receive feeding behavior training. Both the caregiver and the child will take part in feeding behavior training. In order for the training to be successful, the therapist, child, and parent cooperation is necessary. Before this training, the 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 family's approach to the child's behaviors during feeding, regulating the children's feeding behavior problems with extinguishing and desensitization methods, and organizing the feeding environment, and creating a personalized training plan.

Cerebral visual impairment intervention group

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 as needed. Children will be supported with sensory stimuli in order to ensure that the child focuses and remains calm. Sensory integration training will be planned by taking into account the Dunn Sensory Profile test results. In this training, different patterned fabrics, plushes, and toys with different surfaces for tactile stimulation will be provided to maintain the child's calmness and focus; swings and exercise balls for vestibular stimulation; and training to provide sensory regulation with proprioceptive approaches. In addition, within the scope of sensory integration training, stimuli will be provided in the oral region according to the children's sensory responses to the texture, taste, and content of foods.

Ceerbral visual impairment children (control group)Cerebral visual impairment intervention group

Eligibility Criteria

Age48 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Special Education Center

Ankara, Ankara, 22030, Turkey (Türkiye)

Location

Related Publications (5)

  • Erol, N., N. Sezgin, and I. Savaşır, Validity studies on Ankara Development Screening Inventory. Turkish Journal of Psychology, 1993. 29(8): p. 16-22.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26057421BACKGROUND
  • Dunn, W., Sensory profile. PsycTESTS Dataset, 1999.

    BACKGROUND
  • Lehman, S.S., Cortical Visual Impairment in the Child with Cerebral Palsy. Cerebral Palsy, 2020: p. 1049-1055.

    BACKGROUND

MeSH Terms

Conditions

Feeding BehaviorBlindness, CorticalCerebral Palsy

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorBlindnessVision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The clinician who conducted the assessment and the clinician who implemented the intervention were different individuals.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled intervention trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 14, 2025

Study Start

November 15, 2023

Primary Completion

December 15, 2024

Study Completion

December 25, 2024

Last Updated

February 14, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Data from this study will not be shared.

Locations