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

Sponsor
Kahramanmaras Sutcu Imam University (Other)
Overall Status
Completed
CT.gov ID
NCT05102955
Collaborator
(none)
120
1
4.4
27.3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Observational questionnaires

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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
120 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Turkish Validity and Reliability of the Visual Function Classification System (VFCS) in Children With Cerebral Palsy (CP)
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Feb 15, 2022
Actual Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • Assessments
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Function Classification System (VFCS) [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.

    Secondary Outcome Measures

    1. Gross Motor Function Classification System (GMFCS) [Day 1]

      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.

    2. Manual Ability Classification System (MACS) [Day 1]

      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.

    3. Communication Function Classification System (CFCS) [Day 1]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hatice Adıgüzel Kahramanmaras Dulkadiroglu Turkey 46100

    Sponsors and Collaborators

    • Kahramanmaras Sutcu Imam University

    Investigators

    • Principal Investigator: hatice adiguzel, PhD, Kahramanmaras Sutcu Imam University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hatice Adiguzel, assistant professor, Kahramanmaras Sutcu Imam University
    ClinicalTrials.gov Identifier:
    NCT05102955
    Other Study ID Numbers:
    • haticeadiguzel
    First Posted:
    Nov 2, 2021
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hatice Adiguzel, assistant professor, Kahramanmaras Sutcu Imam University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022