Cerebral PalsyNCT05799365
Turkish Adaptation Of GMFCS Family Report And The Agreement Of Family and Physiotherapist
An observational study of Cerebral Palsy, run by Muhammet Ayhan ORAL at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- GMFCS-FR Turkish Adaptation
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2018to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- refuse to participate in the study
- Parents of individuals with cerebral palsy who are not between the ages of 2 and 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitaton
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- GMFCS-FR Turkish Adaptation
- Keywords
- Cerebral palsy, Gross motor function, GMFCS, GMFCS-FR
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMFCS-FR Turkish AdaptationOther
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: GMFCS-FR Turkish Adaptation | |
| 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. Receives: Other: GMFCS-FR Turkish Adaptation | |
| 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. Receives: Other: GMFCS-FR Turkish Adaptation | |
| 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. Receives: Other: GMFCS-FR Turkish Adaptation | |
| 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. Receives: Other: GMFCS-FR Turkish Adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GMFCS-FR Turkish Adaptation Reliability
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.
Measured: 30 minutes
Secondary outcomes (1)
GMFCS-FR Turkish Adaptation Inter-Observer Reliability
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start18 Sep 2018
- Primary completion10 Jan 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammet Ayhan ORAL
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Muhammet Ayhan ORAL, Kırıkkale University
- Investigators
- MINTAZE KEREM GUNEL, PROF, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799365
- Sponsor's protocol ID
- GMFCS-FR Turkish Adaptation
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alriksson-Schmidt A, Nordmark E, Czuba T, Westbom L. Stability of the Gross Motor Function Classification System in children and adolescents with cerebral palsy: a retrospective cohort registry study. Dev Med Child Neurol. 2017 Jun;59(6):641-646. doi: 10.1111/dmcn.13385. Epub 2017 Jan 13.
PubMed 28083887Livanelioğlu A, Fizyoterapi KGMSP. Ankara. Yeni Özbek Matbaası
Ford GW, Kitchen WH, Doyle LW, Rickards AL, Kelly E. Changing diagnosis of cerebral palsy in very low birthweight children. Am J Perinatol. 1990 Apr;7(2):178-81. doi: 10.1055/s-2007-999475.
PubMed 2331281Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. doi: 10.1016/j.bpobgyn.2004.02.011.
PubMed 15183137Christine C, Dolk H, Platt MJ, Colver A, Prasauskiene A, Krageloh-Mann I; SCPE Collaborative Group. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev Med Child Neurol Suppl. 2007 Feb;109:35-8. doi: 10.1111/j.1469-8749.2007.tb12626.x. No abstract available.
PubMed 17370480Mayston MJ. People with cerebral palsy: effects of and perspectives for therapy. Neural Plast. 2001;8(1-2):51-69. doi: 10.1155/NP.2001.51.
PubMed 11530888Mayston MJ. Bobath Concept Theory Clinical Practice in Neurological Rehabilitation: Synapse, Spring; 2001. 32-4 p.
Ottenbacher KJ, Msall ME, Lyon NR, Duffy LC, Granger CV, Braun S. Interrater agreement and stability of the Functional Independence Measure for Children (WeeFIM): use in children with developmental disabilities. Arch Phys Med Rehabil. 1997 Dec;78(12):1309-15. doi: 10.1016/s0003-9993(97)90302-6.
PubMed 9421983King G, Chiarello L. Family-centered care for children with cerebral palsy: conceptual and practical considerations to advance care and practice. J Child Neurol. 2014 Aug;29(8):1046-54. doi: 10.1177/0883073814533009. Epub 2014 May 7.
PubMed 24810084Rosenbaum P, King S, Law M, King G, Evans J. Family-centred service: A conceptual framework and research review. Physical & Occupational Therapy in Pediatrics. 1998;18(1):1-20.
Mutlu A, Kara OK, Gunel MK, Karahan S, Livanelioglu A. Agreement between parents and clinicians for the motor functional classification systems of children with cerebral palsy. Disabil Rehabil. 2011;33(11):927-32. doi: 10.3109/09638288.2010.514645. Epub 2010 Sep 3.
PubMed 20815692Wiart L, Ray L, Darrah J, Magill-Evans J. Parents' perspectives on occupational therapy and physical therapy goals for children with cerebral palsy. Disabil Rehabil. 2010;32(3):248-58. doi: 10.3109/09638280903095890.
PubMed 20001831Morris C, Bartlett D. Gross Motor Function Classification System: impact and utility. Dev Med Child Neurol. 2004 Jan;46(1):60-5. doi: 10.1017/s0012162204000118.
PubMed 14974650Morris C, Galuppi BE, Rosenbaum PL. Reliability of family report for the Gross Motor Function Classification System. Dev Med Child Neurol. 2004 Jul;46(7):455-60. doi: 10.1017/s0012162204000751.
PubMed 15230458Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05799365
- Acronym / sponsor ID
- GMFCS-FR Turkish Adaptation
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Gross motor function, GMFCS, GMFCS-FR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Muhammet Ayhan ORALUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 to 4 Years | – | Other: GMFCS-FR Turkish AdaptationThe children with cerebral palsy between the age of 2 and 4. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist. |
| 4 to 6 Years | – | Other: GMFCS-FR Turkish AdaptationThe children with cerebral palsy between the age of 4 and 6. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist. |
| 6 to 12 Years | – | Other: GMFCS-FR Turkish AdaptationThe children with cerebral palsy between the age of 6 and 12. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist. |
| 12 to 18 Years | – | Other: GMFCS-FR Turkish AdaptationThe children with cerebral palsy between the age of 12 and 18. GMFCS-FR Turkish adaptation was applied the childrens mother, father and clinical physiotherapist. |
| 12 to 18 Years Young with Good Cognitive Levels | – | Other: GMFCS-FR Turkish AdaptationThe 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- refuse to participate in the study
- Parents of individuals with cerebral palsy who are not between the ages of 2 and 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMFCS-FR Turkish AdaptationGMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist. | Other | 12 to 18 Years, 12 to 18 Years Young with Good Cognitive Levels, 2 to 4 Years, 4 to 6 Years, 6 to 12 Years |
Primary outcome
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.
1 secondary outcome
GMFCS-FR Turkish Adaptation Inter-Observer Reliability
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Background: PubMed 28083887Alriksson-Schmidt A, Nordmark E, Czuba T, Westbom L. Stability of the Gross Motor Function Classification System in children and adolescents with cerebral palsy: a retrospective cohort registry study. Dev Med Child Neurol. 2017 Jun;59(6):641-646. doi: 10.1111/dmcn.13385. Epub 2017 Jan 13.
- BackgroundLivanelioğlu A, Fizyoterapi KGMSP. Ankara. Yeni Özbek Matbaası
- Background: PubMed 2331281Ford GW, Kitchen WH, Doyle LW, Rickards AL, Kelly E. Changing diagnosis of cerebral palsy in very low birthweight children. Am J Perinatol. 1990 Apr;7(2):178-81. doi: 10.1055/s-2007-999475.
- Background: PubMed 15183137Jacobsson B, Hagberg G. Antenatal risk factors for cerebral palsy. Best Pract Res Clin Obstet Gynaecol. 2004 Jun;18(3):425-36. doi: 10.1016/j.bpobgyn.2004.02.011.
- Background: PubMed 17370480Christine C, Dolk H, Platt MJ, Colver A, Prasauskiene A, Krageloh-Mann I; SCPE Collaborative Group. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev Med Child Neurol Suppl. 2007 Feb;109:35-8. doi: 10.1111/j.1469-8749.2007.tb12626.x. No abstract available.
- Background: PubMed 11530888Mayston MJ. People with cerebral palsy: effects of and perspectives for therapy. Neural Plast. 2001;8(1-2):51-69. doi: 10.1155/NP.2001.51.
- BackgroundMayston MJ. Bobath Concept Theory Clinical Practice in Neurological Rehabilitation: Synapse, Spring; 2001. 32-4 p.
- Background: PubMed 9421983Ottenbacher KJ, Msall ME, Lyon NR, Duffy LC, Granger CV, Braun S. Interrater agreement and stability of the Functional Independence Measure for Children (WeeFIM): use in children with developmental disabilities. Arch Phys Med Rehabil. 1997 Dec;78(12):1309-15. doi: 10.1016/s0003-9993(97)90302-6.
- Background: PubMed 24810084King G, Chiarello L. Family-centered care for children with cerebral palsy: conceptual and practical considerations to advance care and practice. J Child Neurol. 2014 Aug;29(8):1046-54. doi: 10.1177/0883073814533009. Epub 2014 May 7.
- BackgroundRosenbaum P, King S, Law M, King G, Evans J. Family-centred service: A conceptual framework and research review. Physical & Occupational Therapy in Pediatrics. 1998;18(1):1-20.
- Background: PubMed 20815692Mutlu A, Kara OK, Gunel MK, Karahan S, Livanelioglu A. Agreement between parents and clinicians for the motor functional classification systems of children with cerebral palsy. Disabil Rehabil. 2011;33(11):927-32. doi: 10.3109/09638288.2010.514645. Epub 2010 Sep 3.
- Background: PubMed 20001831Wiart L, Ray L, Darrah J, Magill-Evans J. Parents' perspectives on occupational therapy and physical therapy goals for children with cerebral palsy. Disabil Rehabil. 2010;32(3):248-58. doi: 10.3109/09638280903095890.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MINTAZE KEREM GUNEL, PROF study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Muhammet Ayhan ORAL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GMFCS-FR Turkish Adaptation Reliability (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05799365, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.