Feeding Behavior Intervention in Children with Cerebral Visual Impairment

NCT ID: NCT06827743

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-12-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding Behavior Sensory Integration Disorder Cerebral Visual Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled intervention trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
The clinician who conducted the assessment and the clinician who implemented the intervention were different individuals.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cerebral visual impairment intervention group

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

Group Type EXPERIMENTAL

feeding behavior education

Intervention Type BEHAVIORAL

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.

Sensory integration intervention

Intervention Type BEHAVIORAL

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)

Only sensory integration training will be given to this group.

Group Type ACTIVE_COMPARATOR

Sensory integration intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

feeding behavior education

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.

Intervention Type BEHAVIORAL

Sensory integration intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

48 Months

Maximum Eligible Age

72 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Trakya University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

mustafa cemali

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Special Education Center

Ankara, Ankara, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 26057421 (View on PubMed)

Dunn, W., Sensory profile. PsycTESTS Dataset, 1999.

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/186

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect Of Social Robots In Cerebral Palsy
NCT06948227 NOT_YET_RECRUITING NA