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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05799365
Other study ID # GMFCS-FR Turkish Adaptation
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2018
Est. completion date May 1, 2021

Study information

Verified date March 2023
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 1, 2021
Est. primary completion date January 10, 2021
Accepts healthy volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
GMFCS-FR Turkish Adaptation
GMFCS-FR Turkish Adaptation was applied the childrens mother, father and clinical physiotherapist.

Locations

Country Name City State
Turkey Hacettepe University Faculty of Physical Therapy and Rehabilitaton Ankara

Sponsors (2)

Lead Sponsor Collaborator
Muhammet Ayhan ORAL Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (25)

Akpinar P, Tezel CG, Eliasson AC, Icagasioglu A. Reliability and cross-cultural validation of the Turkish version of Manual Ability Classification System (MACS) for children with cerebral palsy. Disabil Rehabil. 2010;32(23):1910-6. doi: 10.3109/09638281003763796. — View Citation

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. — View Citation

Beaton 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. — View Citation

Christine 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. — View Citation

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. — View Citation

Gunel MK, Mutlu A, Tarsuslu T, Livanelioglu A. Relationship among the Manual Ability Classification System (MACS), the Gross Motor Function Classification System (GMFCS), and the functional status (WeeFIM) in children with spastic cerebral palsy. Eur J Pediatr. 2009 Apr;168(4):477-85. doi: 10.1007/s00431-008-0775-1. Epub 2008 Jun 13. — View Citation

Jacobsson 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. — View Citation

King 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. — View Citation

Lin HY, Lin SP, Lin HY, Hsu CH, Chang JH, Kao HA, Hung HY, Peng CC, Lee HC, Chen MR, Tsai JD. Functional independence of Taiwanese children with VACTERL association. Am J Med Genet A. 2012 Dec;158A(12):3101-5. doi: 10.1002/ajmg.a.33643. Epub 2012 Nov 19. — View Citation

Livanelioglu A, Fizyoterapi KGMSP. Ankara. Yeni Özbek Matbaasi

Mayston MJ. Bobath Concept Theory Clinical Practice in Neurological Rehabilitation: Synapse, Spring; 2001. 32-4 p.

Mayston 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. — View Citation

Morris 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. — View Citation

Morris 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. — View Citation

Morris C, Kurinczuk JJ, Fitzpatrick R, Rosenbaum PL. Who best to make the assessment? Professionals' and families' classifications of gross motor function in cerebral palsy are highly consistent. Arch Dis Child. 2006 Aug;91(8):675-9. doi: 10.1136/adc.2005.090597. Epub 2006 Apr 25. — View Citation

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. — View Citation

Oksuz C, Alemdaroglu I, Kilinc M, Abaoglu H, Demirci C, Karahan S, Yilmaz O, Yildirim SA. Reliability and validity of the Turkish version of ABILHAND-Kids' questionnaire in a group of patients with neuromuscular disorders. Physiother Theory Pract. 2017 Oct;33(10):780-787. doi: 10.1080/09593985.2017.1346026. Epub 2017 Jul 17. — View Citation

Ottenbacher KJ, Msall ME, Lyon N, Duffy LC, Granger CV, Braun S. Measuring developmental and functional status in children with disabilities. Dev Med Child Neurol. 1999 Mar;41(3):186-94. doi: 10.1017/s0012162299000377. — View Citation

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. — View Citation

Palisano RJ, Cameron D, Rosenbaum PL, Walter SD, Russell D. Stability of the gross motor function classification system. Dev Med Child Neurol. 2006 Jun;48(6):424-8. doi: 10.1017/S0012162206000934. — View Citation

Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008 Oct;50(10):744-50. doi: 10.1111/j.1469-8749.2008.03089.x. — View Citation

Ramrit S, Yonglitthipagon P, Janyacharoen T, Emasithi A, Siritaratiwat W. The Gross Motor Function Classification System Family Report Questionnaire: reliability between special-education teachers and caregivers. Dev Med Child Neurol. 2017 May;59(5):520-525. doi: 10.1111/dmcn.13356. Epub 2016 Dec 14. — View Citation

Rosenbaum 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.

Wiart 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. — View Citation

Wong V, Wong S, Chan K, Wong W. Functional Independence Measure (WeeFIM) for Chinese children: Hong Kong Cohort. Pediatrics. 2002 Feb;109(2):E36. doi: 10.1542/peds.109.2.e36. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other GMFCS-FR Turkish Adaptation Validity 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
Other Agreement of GMFCS-FR Levels Determined by Mothers, Fathers, young people aged 12 to 18 years with good cognitive level and Clinical physiotherapist Kappa values were calculated for agreement between GMFCS-FR levels determined individually by each participant 30 minutes
Other The Relationship between the GMFCS-FR Levels Determined by Clinical Physiotherapists and the GMFCS Levels Determined by Clinical Physiotherapists 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
Primary 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. 30 minutes
Secondary 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. 30 minutes
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