Spastic Cerebral PalsyNCT06697704
Trunk Somatosensory Function, Trunk Control, and Thoracic Kyphosis in Children With Spastic Cerebral Palsy
An observational study of Spastic Cerebral Palsy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to investigate the relationship between trunk somatosensory function, trunk control, and thoracic kyphosis in children with cerebral palsy. The main questions it seeks to answer are: Is there a relationship between trunk somatosensory function and trunk control? Is there a relationship… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 30 Aug 2024
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with spastic cerebral palsy from city hospital and special education and rehabilitation center in Kocaeli and Sakarya, Turkey will be recruited for this study.
Who may be able to join
- Received a diagnosis from a specialist doctor in the field
- Willing to participate, along with their family
- To be between the ages of 8-18
- The child with CP is able to tolerate the required test positions for the study
Who cannot join
- Received an additional diagnosis (down syndrome, autism, torticollis, etc.) other than CP from a specialist doctor in the field
- Has cognitive problems or attention disorders that prevent him/her from fulfilling the assessment instructions
- Botulinum Toxin A injection to the trunk or extremities, orthopedic surgery, and/or neurosurgery applications have been performed in the last six months.
- Having uncorrected visual and/or hearing problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43020
About this study
Official title: Investigation of the Relationship Between Trunk Somatosensory Function, Trunk Control, and Thoracic Kyphosis in Children With Spastic Cerebral Palsy
This observational study aims to investigate the relationship between trunk somatosensory function, trunk control, and thoracic kyphosis in children with cerebral palsy. The main questions it seeks to answer are:
- Is there a relationship between trunk somatosensory function and trunk control?
- Is there a relationship between trunk somatosensory function and thoracic kyphosis?
- Is there a relationship between trunk control and thoracic kyphosis?
Read the detailed description
Cerebral palsy (CP) is a heterogeneous disease group that occurs due to non-progressive lesion in the developing fetal or infant brain and causes constant and permanent impairments in movement, posture, and motor function. Sensory, perceptual, cognitive, communicative, and/or behavioral disorders, epilepsy, and secondary musculoskeletal problems may accompany motor disorders, the primary symptoms in CP. CP is one of the most common physical disabilities in childhood, with a reported prevalence of approximately 2.11 per 1,000 live births. Children with CP can be classified according to the type of motor impairment (physiological), the parts of the body affected (topographical), the etiology, the associated disorders, the neuroradiological findings (neuroanatomical), the therapy needs (therapeutic) and the functional abilities.The Surveillance of Cerebral Palsy in Europe (SCPE) classified CP as spastic, ataxic, and dyskinetic according to tone and dominant abnormal movement patterns. Spastic type is the most common form (70%).
Children with CP exhibit poor postural control due to abnormal muscle tone and movement patterns. This dysfunctional postural control causes limitations in gross motor skills such as balance and walking, upper extremity activities such as reaching, and oral-motor activities such as eating, swallowing, and speaking. Weak or inadequate postural control affects functional performance, participation in recreational and social activities, and society in children with CP.
The trunk is the reference point for postural control during stabilization and orientation. It is essential to ensure postural alignment, maintain postural balance, and interact with the environment (performing target-oriented activities). Trunk control refers to maintaining an upright posture, adjusting weight bearing, and performing selective movements while keeping the body's center of gravity within the support surface. In summary, trunk control is responsible for the stability and selective movements of the trunk. It is a precursor for ensuring optimal, targeted, selective, and dissociated movements of the head and extremities. Weak or inadequate trunk control is the basis of the limitations in the functional movements of children with CP. Although the pathophysiology is not progressive in CP, musculoskeletal disorders such as increased stiffness of spastic muscles, deterioration in spinal alignment, and joint contractures are observed with age. Weakness in trunk muscles in children and adults with CP may cause increased trunk extension and impaired spinal alignment in the sagittal plane in the sitting position. Impairment of spinal alignment negatively affects the motor function and activities of daily living of children with CP. It has also been found that the pathological alignment of the trunk and pelvis is associated with postural balance in children with CP.
Motor problems are often accompanied by sensory disorders in CP. Sensory disorders may also cause motor dysfunctions since sensory information for movement is impaired in children with CP. 90% of children with CP have sensory dysfunction. Recently, there has been an increasing interest in somatosensation among the senses in CP. The somatosensory system includes all peripheral and central components involved in the transmission and processing of sensory information from the superficial or cutaneous receptors and/or the musculoskeletal system and is closely related to the motor system. Somatosensory can be classified as tactile, proprioceptive, and pain sensation. It has been reported that somatosensory disorders are more common (97%) in children with unilateral CP.
Somatosensory deficits in CP have been associated primarily with damage to the developing brain and secondarily with motor disorders. Studies have also shown that motor impairments and somatosensory deficits are associated with children with CP. The literature shows that the relationship between somatosensory deficits and motor disorders in children with CP is primarily studied in the extremities (especially the upper extremities). A study evaluated trunk somatosensory function and motor impairments in children with CP. Only trunk proprioception (trunk position sense) was evaluated in this study among the somatosensations. A more comprehensive study, including tactile and pain sensations, has yet to be found. This study examines the relationship between trunk somatosensory function, trunk control, and thoracic kyphosis in children with CP.
- Conditions
- Spastic Cerebral Palsy
- Keywords
- cerebral palsy, trunk control, spinal curvature, somatosensory function
- Medical subject headings
- Cerebral Palsy, Spinal Curvatures
What is being measured
The primary outcome is the main question the study is designed to answer.
Light Touch, Tactile Sense
A measure of trunk somatosensory function, using a Semmes-Weinstein Monofilament (SWM) kit, consisting of 20 calibrated monofilaments in the prone position.
Measured: At baseline
Two-Point Discrimination, Tactile Sense
A measure of trunk somatosensory function, using a discriminator in the prone position.
Measured: At baseline
Vibration, Tactile Sense
A measure of trunk somatosensory function, using a 64 Hz tuning fork in the prone position.
Measured: At baseline
Position Sense Reproduction, Proprioception Sense
A measure of trunk somatosensory function, using a digital inclinometer in a comfortable position with their hips and knees flexed to 90 degrees in the sitting position for the 30 degree trunk flexion and 10 degree trunk extension.
Measured: At baseline
Pain Sense
A measure of trunk somatosensory function, using a dolorimeter for the pressure pain threshold in the prone position and the Visual Analogue Scale (VAS) for the pain severity.
Measured: At baseline
Trunk Control
It was evaluated by the Trunk Control Measurement Scale (TCMS). TCMS is a reliable scale that assesses trunk control during functional activities, focusing on two components: static sitting balance and dynamic sitting balance. It consists of 15 items. Static sitting balance (items 1-5) evaluates trunk control while seated, while dynamic sitting balance includes selective movement control (items 6-12) for trunk movements in different planes, and dynamic reaching (items 13-15) for balance during reaching.The maximum scores are 20 for static sitting balance, 28 for selective movement control, and 10 for dynamic reaching. Higher scores indicate better trunk control performance.
Measured: At baseline
Thoracic Kyphosis
Thoracic kyphosis in participants with cerebral palsy (CP) was assessed using a digital inclinometer. Participants sat comfortably on a Bobath bed with their hips and knees flexed at 90 degrees and feet on the floor. The T1 and T12 vertebrae were marked, and a dual digital inclinometer was attached to these points. The recorded value on the inclinometer's screen was noted in degrees.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start22 Apr 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulce KALLEM SEYYAR, PhD, Kutahya Health Sciences University
- Investigators
- Gulce KALLEM SEYYAR, PT, PhD, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697704
- Sponsor's protocol ID
- TYL-2023-127
- Status last verified
- Nov 2024
- First submitted
- 15 Mar 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brun C, Traverse E, Granger E, Mercier C. Somatosensory deficits and neural correlates in cerebral palsy: a scoping review. Dev Med Child Neurol. 2021 Dec;63(12):1382-1393. doi: 10.1111/dmcn.14963. Epub 2021 Jun 17.
PubMed 34145582Auld ML, Boyd RN, Moseley GL, Ware RS, Johnston LM. Impact of tactile dysfunction on upper-limb motor performance in children with unilateral cerebral palsy. Arch Phys Med Rehabil. 2012 Apr;93(4):696-702. doi: 10.1016/j.apmr.2011.10.025. Epub 2012 Feb 22.
PubMed 22360974McLean B, Taylor S, Valentine J, Carey L, Thornton A, Elliott C. Somatosensory discrimination impairment in children with hemiplegic cerebral palsy as measured by the sense_assess(c) kids. Aust Occup Ther J. 2021 Aug;68(4):317-326. doi: 10.1111/1440-1630.12729. Epub 2021 Mar 18.
PubMed 33738799Santana CAS, Dos Santos MM, de Campos AC. Interrelationships of Touch and Proprioception with Motor Impairments in Individuals with Cerebral Palsy: A Systematic Review. Percept Mot Skills. 2022 Jun;129(3):570-590. doi: 10.1177/00315125221093904. Epub 2022 Apr 22.
PubMed 35452588Monica S, Nayak A, Joshua AM, Mithra P, Amaravadi SK, Misri Z, Unnikrishnan B. Relationship between Trunk Position Sense and Trunk Control in Children with Spastic Cerebral Palsy: A Cross-Sectional Study. Rehabil Res Pract. 2021 Aug 19;2021:9758640. doi: 10.1155/2021/9758640. eCollection 2021.
PubMed 34462670
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Trunk Somatosensory Function, Trunk Control, and Thoracic Kyphosis in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06697704
- Acronym / sponsor ID
- TYL-2023-127
- Conditions
- Spastic Cerebral Palsy
- Keywords
- cerebral palsy, trunk control, spinal curvature, somatosensory function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 20 Nov 2024 (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.
This observational study aims to investigate the relationship between trunk somatosensory function, trunk control, and thoracic kyphosis in children with cerebral palsy. The main questions it seeks to answer are:
- Is there a relationship between trunk somatosensory function and trunk control?
- Is there a relationship between trunk somatosensory function and thoracic kyphosis?
- Is there a relationship between trunk control and thoracic kyphosis?
Detailed description
Cerebral palsy (CP) is a heterogeneous disease group that occurs due to non-progressive lesion in the developing fetal or infant brain and causes constant and permanent impairments in movement, posture, and motor function. Sensory, perceptual, cognitive, communicative, and/or behavioral disorders, epilepsy, and secondary musculoskeletal problems may accompany motor disorders, the primary symptoms in CP. CP is one of the most common physical disabilities in childhood, with a reported prevalence of approximately 2.11 per 1,000 live births. Children with CP can be classified according to the type of motor impairment (physiological), the parts of the body affected (topographical), the etiology, the associated disorders, the neuroradiological findings (neuroanatomical), the therapy needs (therapeutic) and the functional abilities.The Surveillance of Cerebral Palsy in Europe (SCPE) classified CP as spastic, ataxic, and dyskinetic according to tone and dominant abnormal movement patterns. Spastic type is the most common form (70%).
Children with CP exhibit poor postural control due to abnormal muscle tone and movement patterns. This dysfunctional postural control causes limitations in gross motor skills such as balance and walking, upper extremity activities such as reaching, and oral-motor activities such as eating, swallowing, and speaking. Weak or inadequate postural control affects functional performance, participation in recreational and social activities, and society in children with CP.
The trunk is the reference point for postural control during stabilization and orientation. It is essential to ensure postural alignment, maintain postural balance, and interact with the environment (performing target-oriented activities). Trunk control refers to maintaining an upright posture, adjusting weight bearing, and performing selective movements while keeping the body's center of gravity within the support surface. In summary, trunk control is responsible for the stability and selective movements of the trunk. It is a precursor for ensuring optimal, targeted, selective, and dissociated movements of the head and extremities. Weak or inadequate trunk control is the basis of the limitations in the functional movements of children with CP. Although the pathophysiology is not progressive in CP, musculoskeletal disorders such as increased stiffness of spastic muscles, deterioration in spinal alignment, and joint contractures are observed with age. Weakness in trunk muscles in children and adults with CP may cause increased trunk extension and impaired spinal alignment in the sagittal plane in the sitting position. Impairment of spinal alignment negatively affects the motor function and activities of daily living of children with CP. It has also been found that the pathological alignment of the trunk and pelvis is associated with postural balance in children with CP.
Motor problems are often accompanied by sensory disorders in CP. Sensory disorders may also cause motor dysfunctions since sensory information for movement is impaired in children with CP. 90% of children with CP have sensory dysfunction. Recently, there has been an increasing interest in somatosensation among the senses in CP. The somatosensory system includes all peripheral and central components involved in the transmission and processing of sensory information from the superficial or cutaneous receptors and/or the musculoskeletal system and is closely related to the motor system. Somatosensory can be classified as tactile, proprioceptive, and pain sensation. It has been reported that somatosensory disorders are more common (97%) in children with unilateral CP.
Somatosensory deficits in CP have been associated primarily with damage to the developing brain and secondarily with motor disorders. Studies have also shown that motor impairments and somatosensory deficits are associated with children with CP. The literature shows that the relationship between somatosensory deficits and motor disorders in children with CP is primarily studied in the extremities (especially the upper extremities). A study evaluated trunk somatosensory function and motor impairments in children with CP. Only trunk proprioception (trunk position sense) was evaluated in this study among the somatosensations. A more comprehensive study, including tactile and pain sensations, has yet to be found. This study examines the relationship between trunk somatosensory function, trunk control, and thoracic kyphosis in children with CP.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with spastic cerebral palsy from city hospital and special education and rehabilitation center in Kocaeli and Sakarya, Turkey will be recruited for this study.
Key inclusion criteria (4 listed)
- Received a diagnosis from a specialist doctor in the field
- Willing to participate, along with their family
- To be between the ages of 8-18
- The child with CP is able to tolerate the required test positions for the study
Key exclusion criteria (4 listed)
- Received an additional diagnosis (down syndrome, autism, torticollis, etc.) other than CP from a specialist doctor in the field
- Has cognitive problems or attention disorders that prevent him/her from fulfilling the assessment instructions
- Botulinum Toxin A injection to the trunk or extremities, orthopedic surgery, and/or neurosurgery applications have been performed in the last six months.
- Having uncorrected visual and/or hearing problems
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
Light Touch, Tactile Sense
Time frame: At baseline
A measure of trunk somatosensory function, using a Semmes-Weinstein Monofilament (SWM) kit, consisting of 20 calibrated monofilaments in the prone position.
Two-Point Discrimination, Tactile Sense
Time frame: At baseline
A measure of trunk somatosensory function, using a discriminator in the prone position.
Vibration, Tactile Sense
Time frame: At baseline
A measure of trunk somatosensory function, using a 64 Hz tuning fork in the prone position.
Position Sense Reproduction, Proprioception Sense
Time frame: At baseline
A measure of trunk somatosensory function, using a digital inclinometer in a comfortable position with their hips and knees flexed to 90 degrees in the sitting position for the 30 degree trunk flexion and 10 degree trunk extension.
Pain Sense
Time frame: At baseline
A measure of trunk somatosensory function, using a dolorimeter for the pressure pain threshold in the prone position and the Visual Analogue Scale (VAS) for the pain severity.
Trunk Control
Time frame: At baseline
It was evaluated by the Trunk Control Measurement Scale (TCMS). TCMS is a reliable scale that assesses trunk control during functional activities, focusing on two components: static sitting balance and dynamic sitting balance. It consists of 15 items. Static sitting balance (items 1-5) evaluates trunk control while seated, while dynamic sitting balance includes selective movement control (items 6-12) for trunk movements in different planes, and dynamic reaching (items 13-15) for balance during reaching.The maximum scores are 20 for static sitting balance, 28 for selective movement control, and 10 for dynamic reaching. Higher scores indicate better trunk control performance.
Thoracic Kyphosis
Time frame: At baseline
Thoracic kyphosis in participants with cerebral palsy (CP) was assessed using a digital inclinometer. Participants sat comfortably on a Bobath bed with their hips and knees flexed at 90 degrees and feet on the floor. The T1 and T12 vertebrae were marked, and a dual digital inclinometer was attached to these points. The recorded value on the inclinometer's screen was noted in degrees.
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 20 Nov 2024.
- Background: PubMed 34145582Brun C, Traverse E, Granger E, Mercier C. Somatosensory deficits and neural correlates in cerebral palsy: a scoping review. Dev Med Child Neurol. 2021 Dec;63(12):1382-1393. doi: 10.1111/dmcn.14963. Epub 2021 Jun 17.
- Background: PubMed 22360974Auld ML, Boyd RN, Moseley GL, Ware RS, Johnston LM. Impact of tactile dysfunction on upper-limb motor performance in children with unilateral cerebral palsy. Arch Phys Med Rehabil. 2012 Apr;93(4):696-702. doi: 10.1016/j.apmr.2011.10.025. Epub 2012 Feb 22.
- Background: PubMed 33738799McLean B, Taylor S, Valentine J, Carey L, Thornton A, Elliott C. Somatosensory discrimination impairment in children with hemiplegic cerebral palsy as measured by the sense_assess(c) kids. Aust Occup Ther J. 2021 Aug;68(4):317-326. doi: 10.1111/1440-1630.12729. Epub 2021 Mar 18.
- Background: PubMed 35452588Santana CAS, Dos Santos MM, de Campos AC. Interrelationships of Touch and Proprioception with Motor Impairments in Individuals with Cerebral Palsy: A Systematic Review. Percept Mot Skills. 2022 Jun;129(3):570-590. doi: 10.1177/00315125221093904. Epub 2022 Apr 22.
- Background: PubMed 34462670Monica S, Nayak A, Joshua AM, Mithra P, Amaravadi SK, Misri Z, Unnikrishnan B. Relationship between Trunk Position Sense and Trunk Control in Children with Spastic Cerebral Palsy: A Cross-Sectional Study. Rehabil Res Pract. 2021 Aug 19;2021:9758640. doi: 10.1155/2021/9758640. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Gulce KALLEM SEYYAR, PT, PhD study director
Kutahya Health Sciences 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 Spastic Cerebral Palsy, run by Kutahya Health Sciences 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 4 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 20 Nov 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?
Light Touch, Tactile Sense (time frame: At baseline). The study lists 7 primary outcomes in all. 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 NCT06697704, which also lists 5 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 20 Nov 2024.