Cerebral PalsyNCT05102955
Turkish Validity and Reliability of the Visual Function Classification System (VFCS)
An observational study of Cerebral Palsy and Visual Impairment, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is the most common childhood disorder that occurs with a lesion in the developing infant brain, seen in 2-3/1000 live births. CP is a posture, movement and tone disorder that occurs due to prenatal or postnatal causes. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Cerebral Palsy, Visual Impairment, Visual Disorder
- What is being tested?
- Observational questionnaires
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 15 Mar 2022
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with CP of different clinical types in the 1-18 age range
Who may be able to join
- -Children with CP diagnosed with CP between the ages of 1-18 with visual perception problems and visual impairments
Who cannot join
- Individuals with CP whose parents did not sign the voluntary consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatice Adıgüzel
Kahramanmaraş, Dulkadiroglu, 46100
About this study
Official title: Turkish Validity and Reliability of the Visual Function Classification System (VFCS) in Children With Cerebral Palsy (CP)
Cerebral Palsy (CP) is the most common childhood disorder that occurs with a lesion in the developing infant brain, seen in 2-3/1000 live births. CP is a posture, movement and tone disorder that occurs due to prenatal or postnatal causes. It is not progressive, but since the anatomy of the lesion and the physical development of the individual are not completed, the course of the disorder may vary throughout life. Accompanied by motor dysfunctions, it varies according to clinical types. In addition to this, various visual, sensory and behavioral problems, speech disorders that cause learning difficulties and cognitive problems can also be observed. Ophthalmic disorders are the most common problem in CP and can also affect the developmental process of the patient. Since ophthalmic disorders and neurological deficits are associated in CP, the relationship between neurological disorder and ophthalmic disorders has been investigated in the literature. The aim of this study is to establish the Turkish validity and reliability of the Visual Function Classification System (VFCS) specific to individuals with Cerebral Palsy (CP).
Read the detailed description
Cerebral Palsy (CP) is the most common childhood disorder that occurs with a lesion in the developing infant brain, seen in 2-3/1000 live births. CP is a posture, movement and tone disorder that occurs due to prenatal or postnatal causes. It is not progressive, but since the anatomy of the lesion and the physical development of the individual are not completed, the course of the disorder may vary throughout life. Accompanied by motor dysfunctions, it varies according to clinical types. In addition to this, various visual, sensory and behavioral problems, speech disorders that cause learning difficulties and cognitive problems can also be observed. Ophthalmic disorders are the most common problem in CP and can also affect the developmental process of the patient. Since ophthalmic disorders and neurological deficits are associated in CP, the relationship between neurological disorder and ophthalmic disorders has been investigated in the literature. Studies show that 60-70% of children with CP also have CVI. CVI is defined as a lack of visual function resulting from damage or disruption of the retrogeniculate visual pathways (optic radiations, occipital cortex, visual associative areas) in the absence of any major ocular disease. This involvement of the retrogeniculate visual pathways is common in CP, given that the lesions most commonly underlying this condition also affect the visual areas of the brain. CVI is defined as bilateral loss of central visual function (visual acuity) caused by neurological damage to the visual cortex and⁄or visual pathway structures. It is most commonly caused by hypoxic ischemia causing periventricular leukomalacia (PVL) in the preterm infant. Disturbance of the oculomotor system is also typical in CP. Abnormalities in functions such as fixation, tracking and saccadic movements; Strabismus and abnormal ocular movements are also frequently described. With the participation of visual relational areas, visual perception and integration disorders, which are often seen as visual cognitive disorders, can occur when the child reaches school age. These impairments should be investigated even when visual functions such as visual acuity and visual field are normal or mildly impaired.Gross Motor Classification System (GMFCS) and Manual Skill Classification System (MACS) are used by clinicians to obtain a clear picture of how motor skills of individuals with CP, mobility levels in daily life and independence levels of hand functions are affected. However, although it is known that children with CP have visual effects, the methods in which visual functions are classified are insufficient. Therefore, Baranello et al. A tool has been developed to classify the visual function classification system. The aim of this study is to establish the Turkish validity and reliability of the Visual Function Classification System (VFCS) specific to individuals with Cerebral Palsy (CP).
- Conditions
- Cerebral Palsy, Visual Impairment, Visual Disorder, Cerebral Visual Impairment, Cerebral Palsy, Spastic
- Being tested
- Observational questionnaires
- Keywords
- Cerebral Palsy, Visual Function Classification System (VFCS), validity, reliability, Visual Impairment, Visual Disorder
- Medical subject headings
- Cerebral Palsy, Vision Disorders, Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational questionnairesOther
Also called Assessments
All one Group/ Visual Function Classification System(VFCS), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System(CFCS) Questionnaires will be assessed by the different raters (physiotherapists). But Visual Function Classification System(VFCS) will be assesed also by the parents.
| Study group | Role | What they receive |
|---|---|---|
| 1/Observational Questionnaires | All one Group/ Visual Function Classification System(VFCS), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System(CFCS) Questionnaires will be assessed by the different raters(physiotherapists). But Visual Function Classification System(VFCS) will be assesed also by the parents. Receives: Other: Observational questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function Classification System (VFCS)
The VFCS was developed empirically following a step-by step process to classify visual abilities of children with CP in everyday life. VFCS levels will be scored as; LEVEL I: Uses visual function easily and successfully in vision-related activities. LEVEL II: Uses visual function successfully but needs self-initiated compensatory strategies. LEVEL III: Uses visual function but needs some adaptations. LEVEL IV: Uses visual function in very adapted environments but performs just part of vision-related activities. LEVEL V: Does not use visual function even in very adapted environments.The same TWO physiotherapists and parents (M) of children with CP will re-apply the VFCS classifications to individuals with CP at 15-day intervals.
Measured: The same physiotherapists and parents (P) of children with CP will re-apply the VFCS classifications to individuals with CP up to 15-day after the first assessment.
Secondary outcomes (3)
Gross Motor Function Classification System (GMFCS)
Gross Motor Function Classification System (GMFCS), which defines both disease severity and disease course, is used to classify motor impairment in children with cerebral palsy. This system is a system that is used to inform the family about the instant performance of the child. Gross Motor Function Classification System is a valid and reliable standardized system that classifies the gross motor functions of children with CP between the ages of 0-12 at five levels. Children with cerebral palsy are least dependent at level 1 and most dependent at level 5 in motor functions.
Measured: Day 1
Manual Ability Classification System (MACS)
MACS determines how children with CP use their hands while holding objects in daily activities. MACS; defines five levels. The determination of levels is based on the child's ability to hold objects to himself and the need for assistance and adaptation in performing manual activities in daily life. MACS aims to categorize what a child does in general, not how well he performs during a specific test. MACS assesses the usual general ability to hold objects, not the function of the two hands separately or their ability to grasp. Instead of considering the difference in function between the two hands, MACS considers how the child handles objects appropriate for his age. MACS can be used for children aged 4-18. Levels I, II, III include children with minor limitations, while children with severe functional limitations will usually be found at levels IV and V.
Measured: Day 1
Communication Function Classification System (CFCS)
The CFCS assesses the communication functions of an individual with CP in daily life on a five-level scale. The differences between the five levels of the CFCS are based on important aspects of functional communication, namely the performance of the sender and receiver roles, the speed of the conversation, and the communication partner type. Turkish validity and reliability were established.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Nov 2021
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Adiguzel, Kahramanmaras Sutcu Imam University
- Investigators
- hatice adiguzel, PhD, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102955
- Sponsor's protocol ID
- haticeadiguzel
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adiguzel Tat H, Karadeniz PG, Apaydin U, Efkere PA, Ergun N, Elbasan B. Reliability and Cross-Cultural Validation of the Turkish Version of the Visual Function Classification System (VFCS) for Children with Cerebral Palsy. Dev Neurorehabil. 2024 Nov;27(8):328-336. doi: 10.1080/17518423.2024.2413133. Epub 2024 Oct 13.
PubMed 39396187
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Visual Function Classification System (VFCS) in Children With Cerebral Palsy (CP)
- ClinicalTrials.gov ID
- NCT05102955
- Acronym / sponsor ID
- haticeadiguzel
- Conditions
- Cerebral Palsy, Visual Impairment, Visual Disorder, Cerebral Visual Impairment, Cerebral Palsy, Spastic
- Keywords
- Cerebral Palsy, Visual Function Classification System (VFCS), validity, reliability, Visual Impairment, Visual Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 2 Nov 2021 (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.
Cerebral Palsy (CP) is the most common childhood disorder that occurs with a lesion in the developing infant brain, seen in 2-3/1000 live births. CP is a posture, movement and tone disorder that occurs due to prenatal or postnatal causes. It is not progressive, but since the anatomy of the lesion and the physical development of the individual are not completed, the course of the disorder may vary throughout life. Accompanied by motor dysfunctions, it varies according to clinical types. In addition to this, various visual, sensory and behavioral problems, speech disorders that cause learning difficulties and cognitive problems can also be observed. Ophthalmic disorders are the most common problem in CP and can also affect the developmental process of the patient. Since ophthalmic disorders and neurological deficits are associated in CP, the relationship between neurological disorder and ophthalmic disorders has been investigated in the literature. The aim of this study is to establish the Turkish validity and reliability of the Visual Function Classification System (VFCS) specific to individuals with Cerebral Palsy (CP).
Detailed description
Cerebral Palsy (CP) is the most common childhood disorder that occurs with a lesion in the developing infant brain, seen in 2-3/1000 live births. CP is a posture, movement and tone disorder that occurs due to prenatal or postnatal causes. It is not progressive, but since the anatomy of the lesion and the physical development of the individual are not completed, the course of the disorder may vary throughout life. Accompanied by motor dysfunctions, it varies according to clinical types. In addition to this, various visual, sensory and behavioral problems, speech disorders that cause learning difficulties and cognitive problems can also be observed. Ophthalmic disorders are the most common problem in CP and can also affect the developmental process of the patient. Since ophthalmic disorders and neurological deficits are associated in CP, the relationship between neurological disorder and ophthalmic disorders has been investigated in the literature. Studies show that 60-70% of children with CP also have CVI. CVI is defined as a lack of visual function resulting from damage or disruption of the retrogeniculate visual pathways (optic radiations, occipital cortex, visual associative areas) in the absence of any major ocular disease. This involvement of the retrogeniculate visual pathways is common in CP, given that the lesions most commonly underlying this condition also affect the visual areas of the brain. CVI is defined as bilateral loss of central visual function (visual acuity) caused by neurological damage to the visual cortex and⁄or visual pathway structures. It is most commonly caused by hypoxic ischemia causing periventricular leukomalacia (PVL) in the preterm infant. Disturbance of the oculomotor system is also typical in CP. Abnormalities in functions such as fixation, tracking and saccadic movements; Strabismus and abnormal ocular movements are also frequently described. With the participation of visual relational areas, visual perception and integration disorders, which are often seen as visual cognitive disorders, can occur when the child reaches school age. These impairments should be investigated even when visual functions such as visual acuity and visual field are normal or mildly impaired.Gross Motor Classification System (GMFCS) and Manual Skill Classification System (MACS) are used by clinicians to obtain a clear picture of how motor skills of individuals with CP, mobility levels in daily life and independence levels of hand functions are affected. However, although it is known that children with CP have visual effects, the methods in which visual functions are classified are insufficient. Therefore, Baranello et al. A tool has been developed to classify the visual function classification system. The aim of this study is to establish the Turkish validity and reliability of the Visual Function Classification System (VFCS) specific to individuals with Cerebral Palsy (CP).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Observational Questionnaires | – | Other: Observational questionnairesAll one Group/ Visual Function Classification System(VFCS), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System(CFCS) Questionnaires will be assessed by the different raters(physiotherapists). But Visual Function Classification System(VFCS) will be assesed also by the parents. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with CP of different clinical types in the 1-18 age range
Key inclusion criteria (1 listed)
- -Children with CP diagnosed with CP between the ages of 1-18 with visual perception problems and visual impairments
Key exclusion criteria (1 listed)
- Individuals with CP whose parents did not sign the voluntary consent form
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 |
|---|---|---|
| Observational questionnairesAlso: AssessmentsAll one Group/ Visual Function Classification System(VFCS), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), Communication Function Classification System(CFCS) Questionnaires will be assessed by the different raters (physiotherapists). But Visual Function Classification System(VFCS) will be assesed also by the parents. | Other | 1/Observational Questionnaires |
Primary outcome
Visual Function Classification System (VFCS)
Time frame: The same physiotherapists and parents (P) of children with CP will re-apply the VFCS classifications to individuals with CP up to 15-day after the first assessment.
The VFCS was developed empirically following a step-by step process to classify visual abilities of children with CP in everyday life. VFCS levels will be scored as; LEVEL I: Uses visual function easily and successfully in vision-related activities. LEVEL II: Uses visual function successfully but needs self-initiated compensatory strategies. LEVEL III: Uses visual function but needs some adaptations. LEVEL IV: Uses visual function in very adapted environments but performs just part of vision-related activities. LEVEL V: Does not use visual function even in very adapted environments.The same TWO physiotherapists and parents (M) of children with CP will re-apply the VFCS classifications to individuals with CP at 15-day intervals.
3 secondary outcomes
Gross Motor Function Classification System (GMFCS)
Time frame: Day 1
Manual Ability Classification System (MACS)
Time frame: Day 1
Communication Function Classification System (CFCS)
Time frame: Day 1
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 7 Apr 2022.
- Derived from this study: PubMed 39396187Adiguzel Tat H, Karadeniz PG, Apaydin U, Efkere PA, Ergun N, Elbasan B. Reliability and Cross-Cultural Validation of the Turkish Version of the Visual Function Classification System (VFCS) for Children with Cerebral Palsy. Dev Neurorehabil. 2024 Nov;27(8):328-336. doi: 10.1080/17518423.2024.2413133. Epub 2024 Oct 13.
- Individual participant dataSharing planned: No
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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.
hatice adiguzel, PhD principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Visual Impairment, run by Kahramanmaras Sutcu Imam 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 1 inclusion and 1 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 7 Apr 2022. 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?
Visual Function Classification System (VFCS) (time frame: The same physiotherapists and parents (P) of children with CP will re-apply the VFCS classifications to individuals with CP up to 15-day after the first assessment.). 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 NCT05102955, which also lists 1 linked publication.
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 7 Apr 2022.