Cerebral PalsyNCT03241160
Chewing Disorders, Gross Motor Function and Trunk Control in Cerebral Palsy
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Chewing evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 119 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2017to 8 Sep 2017
- 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 2 to 12 years
- All sexes
- Child
Study population: Children with a diagnosis of spastic cerebral palsy
Who may be able to join
- Having a diagnosis of cerebral palsy
- Referring by a pediatric neurologist
- Aging between 2 to 12 years
Who cannot join
- Aging under the age of 24 months
- Using any medicine and/or oral appliances that could affect the chewing performance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Severity of Chewing Disorders is Related to Gross Motor Function and Trunk Control in Cerebral Palsy
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).
Read the detailed description
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance level will be determined by the chewing performance scale. The Gross Motor Function Classification System (GMFCS) will be used to determine gross motor function levels. Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The correlations between chewing performance level and gross motor function, and trunk postural control will be assessed. The Chi-square test will also be used to compare GMFCS levels and trunk control in children with and without chewing disorders.
- Conditions
- Cerebral Palsy
- Being tested
- Chewing evaluation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing evaluationOther
Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Children with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included. Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded. Chewing evaluation will be performed. Receives: Other: Chewing evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chewing evaluation
Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
Measured: 15 days
Secondary outcomes (2)
Gross motor function evaluation
Gross motor function evaluation will be performed according to the Gross Motor Function Classification System.
Measured: 15 days
Trunk control evaluation
Segmental Assessment of Trunk Control (SATCo) will be performed.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start5 Aug 2017
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- SELEN SEREL ARSLAN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241160
- Sponsor's protocol ID
- HACETTEPE
- Status last verified
- Sep 2017
- First submitted
- 2 Aug 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Serel Arslan S, Demir N, Inal O, Karaduman AA. The severity of chewing disorders is related to gross motor function and trunk control in children with cerebral palsy. Somatosens Mot Res. 2018 Sep-Dec;35(3-4):178-182. doi: 10.1080/08990220.2018.1521788. Epub 2018 Dec 28.
PubMed 30592431
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Severity of Chewing Disorders is Related to Gross Motor Function and Trunk Control in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03241160
- Acronym / sponsor ID
- HACETTEPE
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Aug 2017 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 7 Aug 2017 (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.
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).
Detailed description
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance level will be determined by the chewing performance scale. The Gross Motor Function Classification System (GMFCS) will be used to determine gross motor function levels. Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The correlations between chewing performance level and gross motor function, and trunk postural control will be assessed. The Chi-square test will also be used to compare GMFCS levels and trunk control in children with and without chewing disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | Other: Chewing evaluationChildren with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included. Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded. Chewing evaluation will be performed. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with a diagnosis of spastic cerebral palsy
Key inclusion criteria (3 listed)
- Having a diagnosis of cerebral palsy
- Referring by a pediatric neurologist
- Aging between 2 to 12 years
Key exclusion criteria (2 listed)
- Aging under the age of 24 months
- Using any medicine and/or oral appliances that could affect the chewing performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chewing evaluationChewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing. | Other | Children with cerebral palsy |
Primary outcome
Chewing evaluation
Time frame: 15 days
Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
2 secondary outcomes
Gross motor function evaluation
Time frame: 15 days
Trunk control evaluation
Time frame: 15 days
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 11 Sep 2017.
- Derived from this study: PubMed 30592431Serel Arslan S, Demir N, Inal O, Karaduman AA. The severity of chewing disorders is related to gross motor function and trunk control in children with cerebral palsy. Somatosens Mot Res. 2018 Sep-Dec;35(3-4):178-182. doi: 10.1080/08990220.2018.1521788. Epub 2018 Dec 28.
- 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.
SELEN SEREL ARSLAN principal investigator
Hacettepe 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 Hacettepe 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 3 inclusion and 2 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 11 Sep 2017. 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?
Chewing evaluation (time frame: 15 days). 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 NCT03241160, which also lists 1 linked publication.
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 11 Sep 2017; AzTrials last refreshed its copy on 30 Oct 2026.