Feeding BehaviorNCT06827743
Feeding Behavior Intervention in Children with Cerebral Visual Impairment
A study testing feeding behavior education and Sensory integration intervention in people with Feeding Behavior and Sensory Integration Disorder, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 48 to 72 monthsHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior, Sensory Integration Disorder, Cerebral Visual Impairment
- What is being tested?
- feeding behavior education and Sensory integration intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Special Education Center
Ankara, Ankara, 22030
About this study
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
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.
Read the 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.
- Being tested
- feeding behavior education, Sensory integration intervention
- Keywords
- Feeding Behavior, Sensory Integration Disorder, Cerebral Visual Impairment, Cerebral palsy
- Medical subject headings
- Feeding Behavior, Blindness, Cortical, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feeding behavior educationBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral visual impairment intervention group | Experimental | In addition to sensory integration training, nutritional behavior training will be given to this group. Receives: Behavioral: feeding behavior education; Behavioral: Sensory integration intervention |
| Ceerbral visual impairment children (control group) | Active comparator | Only sensory integration training will be given to this group. Receives: Behavioral: Sensory integration intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Dunn Sensory Profile
The Sensory Profile developed by Dunn is a 125-question questionnaire used in sensory assessment in children aged 3-10. This questionnaire is answered by the caregiver who is in frequent contact with the child in daily life. It includes questions about many senses such as auditory processing, visual processing, vestibular processing, tactile processing, multi-sensory processing and oral sensory processing. The items are evaluated using 5-point frequency responses between always and never. A higher score for each subdomain means worse sensory processing. The Turkish validity and reliability studies of the scale were conducted by Kayıhan et al. The Cronbach α values of the questionnaire are between 0.63 and 0.97 for all subdomains.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start15 Nov 2023
- Primary completion15 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled intervention trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mustafa cemali, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827743
- Sponsor's protocol ID
- 2023/186
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this study will not be shared.
Publications
Erol, N., N. Sezgin, and I. Savaşır, Validity studies on Ankara Development Screening Inventory. Turkish Journal of Psychology, 1993. 29(8): p. 16-22.
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.
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.
PubMed 26057421Dunn, W., Sensory profile. PsycTESTS Dataset, 1999.
Lehman, S.S., Cortical Visual Impairment in the Child with Cerebral Palsy. Cerebral Palsy, 2020: p. 1049-1055.
Cemali O, Tiryaki AY, Cemali M, Torpil B. Effects of feeding behavior training on sensory processing and developmental areas in children with cerebral visual impairment: a randomized controlled study. Ital J Pediatr. 2026 Feb 14;52(1):42. doi: 10.1186/s13052-026-02213-w.
PubMed 41691324
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06827743
- Acronym / sponsor ID
- 2023/186
- Keywords
- Feeding Behavior, Sensory Integration Disorder, Cerebral Visual Impairment, Cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized controlled intervention trial
| Arm | Type | Receives |
|---|---|---|
| Cerebral visual impairment intervention group | Experimental | Behavioral: feeding behavior education, Behavioral: Sensory integration interventionIn addition to sensory integration training, nutritional behavior training will be given to this group. |
| Ceerbral visual impairment children (control group) | Active comparator | Behavioral: Sensory integration interventionOnly sensory integration training will be given to this group. |
Who may qualify
- Ages
- 48 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Children with Cerebral Palsy Diagnosed with Cerebral Visual Impairment in Hospital Report
Key exclusion criteria (4 listed)
- Not accepting to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| feeding behavior educationTwo 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. | Behavioural | Cerebral visual impairment intervention group |
| Sensory integration interventionThe 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. | Behavioural | Ceerbral visual impairment children (control group), Cerebral visual impairment intervention group |
Primary outcome
Behavioral Pediatric Feeding Assessment Scale
Time frame: 12 weeks
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.
1 secondary outcome
Dunn Sensory Profile
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- BackgroundErol, N., N. Sezgin, and I. Savaşır, Validity studies on Ankara Development Screening Inventory. Turkish Journal of Psychology, 1993. 29(8): p. 16-22.
- BackgroundOnal, 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: PubMed 26057421Kayihan 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.
- BackgroundDunn, W., Sensory profile. PsycTESTS Dataset, 1999.
- BackgroundLehman, S.S., Cortical Visual Impairment in the Child with Cerebral Palsy. Cerebral Palsy, 2020: p. 1049-1055.
- Derived from this study: PubMed 41691324Cemali O, Tiryaki AY, Cemali M, Torpil B. Effects of feeding behavior training on sensory processing and developmental areas in children with cerebral visual impairment: a randomized controlled study. Ital J Pediatr. 2026 Feb 14;52(1):42. doi: 10.1186/s13052-026-02213-w.
- Individual participant dataSharing planned: No. Data from this study will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing feeding behavior education and Sensory integration intervention in people with Feeding Behavior and Sensory Integration Disorder, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Pediatric Feeding Assessment Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827743, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.