Cerebral PalsyNCT05757895
Investigation of Trunk Control in Spatic Cerebral Palsy
An observational study of Cerebral Palsy, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 16 patients with Hemiparetic CP and 16 Diparetic CP will be included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, trunk control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First Day
Secondary outcomes (3)
Activity Level
Not to measure the feasibility of the quality of the movement, the international functionality, disability and health as defined in the classification of the 'activity level' and determine tilt, rolling, sitting, crawling, kneeling, standing, walking, jumping, running, containing parameters such as the functional activity of focusing on gross motor function Criteria - GMFM-88 will be assessed.
Measured: First Day
Level of Participation
The functional health status of children and adolescents with CP between the ages of 2-18 will be evaluated by the Pediatric Data Collection Tool (PODCI), which is developed to determine the level of physical function and participation, but also does not ignore the quality of life, answered by parents.
Measured: First Day
The level of Quality of Life
SP-specific developed in order to assess the quality of life, daily activities, school activities, movement and balance, pain and suffering, fatigue, eating, activities, speech and communication, including 7 Sub Module titles for children of cerebral palsy quality of Life.
Measured: First Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, METEHAN YANA, Karabuk University
- Investigators
- Funda ŞEKERCİOĞLU Physiotherapist, Study chair, Karabuk UniversityMusa GÜNEŞ MsC, Study director, Karabuk UniversityMetehan YANA PhD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757895
- Sponsor's protocol ID
- Cerebral Palsy
- Status last verified
- Feb 2024
- First submitted
- 24 Feb 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16108461Bourelle 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.
PubMed 20101192Davis 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.
PubMed 19549193Ko 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.
PubMed 23139425Palisano 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.
PubMed 9183258Saether 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.
PubMed 23643761
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05757895
- Acronym / sponsor ID
- Cerebral Palsy
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, trunk control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 16 patients with Hemiparetic CP and 16 Diparetic CP will be included.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trunk Affect Level
Time frame: First Day
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.
3 secondary outcomes
Activity Level
Time frame: First Day
Level of Participation
Time frame: First Day
The level of Quality of Life
Time frame: First Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 16108461Bax 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.
- Background: PubMed 20101192Bourelle 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.
- Background: PubMed 19549193Davis 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.
- Background: PubMed 23139425Ko 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.
- Background: PubMed 9183258Palisano 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.
- Background: PubMed 23643761Saether 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Funda ŞEKERCİOĞLU Physiotherapist study chair
Karabuk University
Musa GÜNEŞ MsC study director
Karabuk University
Metehan YANA PhD principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Affect Level (time frame: First Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05757895, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.