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

April 6, 2022 updated by: Hatice Adiguzel, Kahramanmaras Sutcu Imam University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Dulkadiroglu
      • Kahramanmaras, Dulkadiroglu, Turkey, 46100
        • Hatice Adıgüzel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with CP of different clinical types in the 1-18 age range

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFCS)
Time Frame: 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.
Day 1
Manual Ability Classification System (MACS)
Time Frame: 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.
Day 1
Communication Function Classification System (CFCS)
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: hatice Adiguzel, PhD, Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • haticeadiguzel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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