Turkish Adaptation Of GMFCS Family Report And The Agreement Of Family and Physiotherapist

April 4, 2023 updated by: Muhammet Ayhan ORAL

Psychometric Properties Of Turkish Adaptation Of Gross Motor Function Classification System Family Report In Children With Cerebral Palsy And The Agreement Of Family And Physiotherapist

To make the Turkish adaptation of the Gross Motor Function Classification System Family Report (GMFCS-FR) in children with CP, to determine its reliability and validity, and to investigate the agreement of the family and the clinical physiotherapists in determining the gross motor function level.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy (CP) is a heterogeneous, persistent neurological disorder caused by non-progressive damage to the developing brain. This condition occurs as a result of injury or malformation in the developing central nervous system before, during or immediately after birth. This situation, which develops secondary to lesions or abnormalities of the central nervous system, affects motor function and posture development. As a result of the addition of tertiary disorders to the table with different compensation mechanisms over time, the development and functional independence levels of children are negatively affected.

Diagnosis in CP can be made in the first two years of life, especially when functional impairment is mild. However, there is a consensus that 5 years of age is the most appropriate age to confirm the diagnosis, due to the clinical condition that may change with the development of the child in some cases.

Since recent studies on the rehabilitation of children with CP have focused on increasing functionality in their daily activities, the functional levels and abilities of these children have recently gained more importance. It may be necessary to use some test batteries in order to evaluate the motor development and functional level of the child. Gross Motor Function Classification System (GMFCS) used for functional classification and Pediatric Functional Independence Measure (WeeFIM) used for pediatric functional evaluation of activities of daily living are some of the commonly used test batteries.

In the last 20 years, family-centered approaches have gained importance for children with CP and their families. Family-centered approaches that address the needs of children and their families, and families' involvement in all aspects of services for their children contribute to the establishment of partnership between parents and health professionals. Family-assessed measurements or family reports are invaluable, as families are at the center of the rehabilitation process, with active participation in all phases of CP treatment and management. Therefore, it becomes important to investigate the validity, reliability and stability of classification systems that can also be used by parents.

GMFCS, which is widely used in research and clinical practice for treatment and rehabilitation planning, prognosis and clinical decision making, was modified in 2004 by Morris et al. to be used for parents and named GMFCS Family Report Questionnaire.

The aim of this study is to make the Turkish adaptation of the Gross Motor Function Classification System Family Report (GMFCS-FR) in children with CP, to determine its reliability and validity, and to investigate the agreement of the family and the clinical physiotherapists in determining the gross motor function level.

Study Type

Observational

Enrollment (Actual)

100

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
      • Ankara, Turkey
        • Hacettepe University Faculty of Physical Therapy and Rehabilitaton

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

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study was terminated with the participation of a total of 100 children's parents (mother and father), 18 clinical physiotherapists and 20 young people with CP between the ages of 12 to 18 years with good cognitive level.

Children with CP were divided into four different age groups. 2 to 4 years of age, 4 to 6 years of age, 6 to 12 years of age and 12 to 18 years of age were determined and all examinations were performed according to these groups. A fifth group of GMFCS-FR created for young people aged 12 to 18 years with good cognitive level is called GMFCS-FR self-report. The young people aged 12 to 18 in our study with good cognitive level were included in the 5th group. Each group consisted of 20 children with CP

Description

Inclusion Criteria:

  • Parents of children with cerebral palsy between the ages of 2 and 18 who agreed to participate in the study
  • Clinical physiotherapists of of children with cerebral palsy between the ages of 2 and 18 who agreed to participate in the study

Exclusion Criteria:

  • refuse to participate in the study
  • Parents of individuals with cerebral palsy who are not between the ages of 2 and 18

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
2 to 4 Years
The children with cerebral palsy between the age of 2 and 4. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist.
Other: GMFCS-FR Turkish Adaptation
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.
4 to 6 Years
The children with cerebral palsy between the age of 4 and 6. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist.
Other: GMFCS-FR Turkish Adaptation
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.
6 to 12 Years
The children with cerebral palsy between the age of 6 and 12. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist.
Other: GMFCS-FR Turkish Adaptation
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.
12 to 18 Years
The children with cerebral palsy between the age of 12 and 18. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist.
Other: GMFCS-FR Turkish Adaptation
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.
12 to 18 Years Young with Good Cognitive Levels
The children with cerebral palsy with good cognitive levels between the age of 12 and 18. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist.
Other: GMFCS-FR Turkish Adaptation
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GMFCS-FR Turkish Adaptation Reliability
Time Frame: 30 minutes
For test-retest reliability, the mothers and fathers of each of the 100 children with CP who participated in the study, and young people aged 12 to 18 years with good cognitive level were asked to answer the GMFCS-FR twice, with an interval of 15 days.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMFCS-FR Turkish Adaptation Inter-Observer Reliability
Time Frame: 30 minutes
ICC values were used to determine the interobserver reliability of the questionnaire. The GMFCS levels recorded by the research physiotherapist by learning from the children's clinical physiotherapists and the GMFCS-FR levels determined by mothers, fathers and young people aged 12 to 18 years with good cognitive level were compared.
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMFCS-FR Turkish Adaptation Validity
Time Frame: 30 minutes
The concurrent validity of the GMFCS-FR was evaluated with the Pediatric Functional Independence Measure (WeeFIM 2®). WeeFIM 2® scores were compared with the GMFCS-FR levels determined separately by each of the mothers, fathers and 12 to 18 Years Young with Good Cognitive Levels GMFCS FR-SR. Spearman's Correlation Coefficient was used for analysis.
30 minutes
Agreement of GMFCS-FR Levels Determined by Mothers, Fathers, young people aged 12 to 18 years with good cognitive level and Clinical physiotherapist
Time Frame: 30 minutes
Kappa values were calculated for agreement between GMFCS-FR levels determined individually by each participant
30 minutes
The Relationship between the GMFCS-FR Levels Determined by Clinical Physiotherapists and the GMFCS Levels Determined by Clinical Physiotherapists
Time Frame: 30 minutes
When the relationship between the GMFCS-FR levels of the child determined by the clinical physiotherapists participating in the study and the GMFCS levels was examined
30 minutes

Collaborators and Investigators

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

Sponsor

Muhammet Ayhan ORAL

Collaborators

Hacettepe University

Investigators

  • Study Director: MINTAZE KEREM GUNEL, PROF, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 18, 2018

Primary Completion (Actual)

January 10, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMFCS-FR Turkish Adaptation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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