Clinical trial NCT05757895: Investigation of Trunk Control in Spatic Cerebral Palsy
Official title: Investıgatıon of the Effect of Trunk dısorder Level on partıcıpatıon, actıvıty and qualıty of lıfe Level of chıldren wıth Cerebral Palsy at prımary School Level
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy, trunk control
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 16 patients with Hemiparetic CP and 16 Diparetic CP will be included.

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.

Detailed description: 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.Cerebral palsy, neuromuscular diseases and permanent disability among the most widely known throughout the world as the cause of childhood morbidity and mortality rates in takes place at high rates.Many prenatal, perinatal and postnatal problems play a role in the development of Cerebral Palsy. Between Prenatal intrauterine bleeding problems, toxins and infections; perinatal problems between a difficult birth, anoxia; postnatal problems are considered to be among the most frequent causes of premature and low birth weight.

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, which is a neurological disorder. Insufficient postural control negatively affects mobility, limb movements, static and dynamic trunk control.In recent years, the terms well-being and quality of life have been considered important for the evaluation of health. Well-being is expressed as the well-being of an individual's functional and health condition and an increase in quality of life.SP impaired postural control in children with upper extremity impairment in function, learning difficulties, sensory impairment, dental problems, language-speech disorders, mental retardation, behavior disorders, is illustrated by studies that has a negative impact on quality of life.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Trunk Affect Level
timeFrame: First Day
Secondary outcomes:
measure: Activity Level
timeFrame: First Day
measure: Level of Participation
timeFrame: First Day
measure: The level of Quality of Life
timeFrame: First Day
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük University
Study officials:
affiliation: Karabuk University
name: Funda ŞEKERCİOĞLU Physiotherapist
role: STUDY_CHAIR
affiliation: Karabuk University
name: Musa GÜNEŞ MsC
role: STUDY_DIRECTOR
affiliation: Karabuk University
name: Metehan YANA PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.