NCT05799365

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Typical duration 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

Study Start

First participant enrolled

September 18, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

2.3 years

First QC Date

March 1, 2023

Last Update Submit

April 4, 2023

Conditions

Cerebral Palsy

Keywords

Cerebral palsyGross motor functionGMFCSGMFCS-FR

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • GMFCS-FR Turkish Adaptation Inter-Observer Reliability

    30 minutes

Other Outcomes (3)

  • GMFCS-FR Turkish Adaptation Validity

    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

    30 minutes

  • The Relationship between the GMFCS-FR Levels Determined by Clinical Physiotherapists and the GMFCS Levels Determined by Clinical Physiotherapists

    30 minutes

Study Arms (5)

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

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

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

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

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

Interventions

GMFCS-FR Turkish AdaptationOTHER

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

12 to 18 Years12 to 18 Years Young with Good Cognitive Levels2 to 4 Years4 to 6 Years6 to 12 Years

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitaton

Ankara, Turkey (Türkiye)

Location

Related Publications (25)

  • 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.

    PMID: 28083887BACKGROUND

  • Livanelioğlu A, Fizyoterapi KGMSP. Ankara. Yeni Özbek Matbaası

    BACKGROUND

  • 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.

    PMID: 2331281BACKGROUND

  • 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.

    PMID: 15183137BACKGROUND

  • 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.

    PMID: 17370480BACKGROUND

  • 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.

    PMID: 11530888BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 9421983BACKGROUND

  • 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.

    PMID: 24810084BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 20815692BACKGROUND

  • 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.

    PMID: 20001831BACKGROUND

  • 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.

    PMID: 14974650BACKGROUND

  • 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.

    PMID: 15230458BACKGROUND

  • 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.

    PMID: 11124735BACKGROUND

  • 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.

    PMID: 16700931BACKGROUND

  • 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.

    PMID: 18834387BACKGROUND

  • 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.

    PMID: 20373857BACKGROUND

  • 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.

    PMID: 11826246BACKGROUND

  • 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.

    PMID: 23165933BACKGROUND

  • 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.

    PMID: 10210251BACKGROUND

  • 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.

    PMID: 16638783BACKGROUND

  • 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.

    PMID: 27966216BACKGROUND

  • 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.

    PMID: 28715270BACKGROUND

  • 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.

    PMID: 18551314BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • MINTAZE KEREM GUNEL, PROF

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

April 5, 2023

Study Start

September 18, 2018

Primary Completion

January 10, 2021

Study Completion

May 1, 2021

Last Updated

April 5, 2023

Record last verified: 2023-03

Locations

TU(1)