NCT05757895

Brief Summary

Cerebral Palsy is a disease characterized by movement, posture and tone disorders that occur in the immature brain structure that has not yet completed its development anatomically and physically, but can undergo permanent changes. Although the prevalence is 2-3/1000 births, this rate is 4.4/1000 births in our country. As the level of development of the country increases, this rate decreases. Cerebral Palsy is clinically classified according to different criteria and types. While the terms hemiplegia, diplegia, tetraplegia are used according to limb involvement, terms such as spastic, ataxic, dyskinetic, hypotonic are used in classification according to dominant tone disorders. Postural control, which plays a key role in the realization of all our fine and gross motor skills and is necessary for the realization of our daily life activities, is insufficient in children with cerebral palsy, a neurological disorder. Insufficient postural control negatively affects mobility, limb movements, static and dynamic trunk control. When the literature is scanned and trunk postural control more of the physical/motor, we investigated the effect of parameters, which are fundamental for the realization of motor body control functions/is not emphasized enough in postural control, within the framework of the ICF activity and participation and the effects on their quality of life has not been sufficiently studied to be a gap in this area, physical/motor control parameters has a significant influence on the body, which is quite activity, participation and quality of life was significantly etkileyecebi it was assumed that their level. In our study, the 6-12 age group was selected because children with Cerebral Palsy at the primary school level have started to become independent from their parents in their daily life activities and have recently adapted to social activities. In this study, it is aimed to investigate the effect of trunk disorder level on activity, participation and quality of life levels of children with Cerebral Palsy at primary school level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

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

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 24, 2023

Last Update Submit

February 15, 2024

Conditions

Keywords

cerebral palsy, trunk control

Outcome Measures

Primary Outcomes (1)

  • Trunk Affect Level

    Static Sitting Balance, Dynamic Sitting Balance and Coordination will be evaluated with the Body Impact Scale (TIS). The scale varies between 0-23 points in total, and high scores indicate that the body control is better.

    First Day

Secondary Outcomes (3)

  • Activity Level

    First Day

  • Level of Participation

    First Day

  • The level of Quality of Life

    First Day

Study Arms (2)

Hemiparetic SP

The Level of Gross Motor Function Classification System (GMFCS), Trunk Affect Level ( Trunk Impairment Scale- TIS), Activity Level ( Gross Motor Function Criterion- GMFM-88), Participation Level ( Pediatric Data Collection Tool- PODCI) and Quality of Life Level (Cerebral Palsy Questionnaire for Children Cerebral Palsy Module- PedsQL) will be evaluated.

Diparetic SP

The Level of Gross Motor Function Classification System (GMFCS), Trunk Affect Level ( Trunk Impairment Scale- TIS), Activity Level ( Gross Motor Function Criterion- GMFM-88), Participation Level ( Pediatric Data Collection Tool- PODCI) and Quality of Life Level (Cerebral Palsy Questionnaire for Children Cerebral Palsy Module- PedsQL) will be evaluated.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

16 patients with Hemiparetic CP and 16 Diparetic CP will be included.

You may qualify if:

  • Diagnosed with Spastic Cerebral Palsy,
  • located in the December 7-12 age range,
  • Without Severe Mental Retardation,
  • GMFCS level 1-2 and 3 are
  • Given consent to participate in the study by the parent

You may not qualify if:

  • Not given consent to participate in the study by the parent,
  • Having a type of SP, other than Spastic Cerebral Palsy,
  • Severe Mental Retardation and inability to communicate
  • not being in the December 7-12 age range -With GMFCS level 4 and 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University

Karabük, 78000, Turkey (Türkiye)

Location

Related Publications (6)

  • Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.

    PMID: 16108461BACKGROUND
  • Bourelle S, Berge B, Gautheron V, Cottalorda J. Computerized static posturographic assessment after treatment of equinus deformity in children with cerebral palsy. J Pediatr Orthop B. 2010 May;19(3):211-20. doi: 10.1097/BPB.0b013e32832e957a.

    PMID: 20101192BACKGROUND
  • Davis E, Shelly A, Waters E, Davern M. Measuring the quality of life of children with cerebral palsy: comparing the conceptual differences and psychometric properties of three instruments. Dev Med Child Neurol. 2010 Feb;52(2):174-80. doi: 10.1111/j.1469-8749.2009.03382.x. Epub 2009 Jun 22.

    PMID: 19549193BACKGROUND
  • Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.

    PMID: 23139425BACKGROUND
  • Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

    PMID: 9183258BACKGROUND
  • Saether R, Helbostad JL, Adde L, Jorgensen L, Vik T. Reliability and validity of the Trunk Impairment Scale in children and adolescents with cerebral palsy. Res Dev Disabil. 2013 Jul;34(7):2075-84. doi: 10.1016/j.ridd.2013.03.029. Epub 2013 May 1.

    PMID: 23643761BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Funda ŞEKERCİOĞLU Physiotherapist

    Karabuk University

    STUDY CHAIR
  • Musa GÜNEŞ MsC

    Karabuk University

    STUDY DIRECTOR
  • Metehan YANA PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

December 31, 2023

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations