NCT05102955

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

October 15, 2021

Last Update Submit

April 6, 2022

Conditions

Keywords

Cerebral PalsyVisual Function Classification System (VFCS)validityreliabilityVisual ImpairmentVisual Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Gross Motor Function Classification System (GMFCS)

    Day 1

  • Manual Ability Classification System (MACS)

    Day 1

  • Communication Function Classification System (CFCS)

    Day 1

Study Arms (1)

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

Interventions

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.

Also known as: Assessments
1/Observational Questionnaires

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatice Adıgüzel

Kahramanmaraş, Dulkadiroglu, 46100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral PalsyVision DisordersBlindness, Cortical

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBlindness

Study Officials

  • hatice adiguzel, PhD

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 15, 2021

First Posted

November 2, 2021

Study Start

November 1, 2021

Primary Completion

February 15, 2022

Study Completion

March 15, 2022

Last Updated

April 7, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations