Investigation of Trunk Control in Spatic Cerebral Palsy

NCT ID: NCT05757895

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karabuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

METEHAN YANA

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Funda ŞEKERCİOĞLU Physiotherapist

Role: STUDY_CHAIR

Karabuk University

Musa GÜNEŞ MsC

Role: STUDY_DIRECTOR

Karabuk University

Metehan YANA PhD

Role: PRINCIPAL_INVESTIGATOR

Karabuk University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Karabük University

Karabük, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16108461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20101192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19549193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23139425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9183258 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23643761 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Cerebral Palsy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.