Turkish Validity and Reliability of the Visual Function Classification System (VFCS)

Cerebral Palsy Clinical Trial

Official title:

Turkish Validity and Reliability of the Visual Function Classification System (VFCS) in Children With Cerebral Palsy (CP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102955
• Other study ID #: haticeadiguzel
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: April 2022
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

-Children with CP diagnosed with CP between the ages of 1-18 with visual perception problems and visual impairments

Exclusion Criteria:

• Individuals with CP whose parents did not sign the voluntary consent form

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy, Spastic
• Cerebral Visual Impairment
• Paralysis
• Vision Disorders
• Vision, Low
• Visual Disorder
• Visual Impairment

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Hatice Adigüzel	Kahramanmaras	Dulkadiroglu

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1