Cerebral PalsyNCT04134533
Comparison of Motor Functions and Quality of Life According to Feeding Type in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Gross Motor Function Measurement
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2019to 15 Jan 2020
- How long will I take part?
- 1 Month
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Cerebral Palsy
Who may be able to join
- Children who were diagnosed with CP
- Aged between 5-18 years
- Must have cooperation
- Feed by orally or non-orally
Who cannot join
- Having other accompanying neurodegenerative diseases.
- Acute respiratory tract infection
- Complications of enteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Functional Level and Quality of Life According to Feeding Types in Children With Cerebral Palsy
The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy.
Read the detailed description
The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. Children will be divided into two groups: children with oral feeding and children with non-oral feeding, according to Functional Oral Intake Scale. Gross Motor Function Classification System will be used for classify children according to gross motor function, Gross Motor Function Measurement will be used for evaluate gross motor functions, and parent-reported Pediatric Quality of Life Inventory will be used for evaluate quality of life of children. To measure caregivers' anxiety and depression levels will be assessed by using Beck Depression Inventory and Beck Anxiety Inventory. Parametric or non-parametric tests will be applied according to the variables distribution. Through this analyses, determination of the difference between feeding type groups and other categorical and continuous variables will be decided.
- Conditions
- Cerebral Palsy
- Being tested
- Gross Motor Function Measurement
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross Motor Function MeasurementOther
Also called Pediatric Quality of Life Inventory, Beck Anxiety Inventory, Beck depression Inventory, Gross Motor Function Classification System
These instruments will be used for determine the gross motor functional level and quality of life of the children with cerebral palsy and anxiety, depression levels of caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Oral Feeding Group | Children with cerebral palsy who fed orally according to the Functional Oral Intake Scale Receives: Other: Gross Motor Function Measurement | |
| Non-Oral Feeding Group | Children with cerebral palsy who fed non-orally according to the Functional Oral Intake Scale. Receives: Other: Gross Motor Function Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor Function Measurement
The Gross Motor Function Measurement (GMFM) is an observational clinical tool to evaluate motor function of children with CP. It has five basic sections that evaluate motor function in detail, including lying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping, with a total of 88 items. Each evaluation is scored according to the level of achieving gross motor function without considering the quality of movement. While children performing each task in the GMFM, a physiotherapist scored each evaluation on a Likert scale between 0 to 3, of which 0 means 'Does not initiate' and 3 means 'Completes'.
Measured: 2 months
Secondary outcomes (3)
Gross Motor Function Classification System
The Gross Motor Function Classification System (GMFCS) was used to classify the level of gross motor functions in children with CP, and levels were based on child-initiated movement abilities, with emphasis on sitting, displacement, and mobility. The GMFCS uses a rating system of Level I to Level V, of which Level I shows the most independent functional motor level and Level V shows the most dependent functional motor level.
Measured: 2 months
Pediatric Quality of Life Inventory
Pediatric Quality of Life Inventory (PedsQL) was used to measure the parent-reported quality of life of children. The items of the PedsQL were scored between 0 to 100, of which 100 means "never", 75 means "almost never", 50 means "sometimes", 25 means "often", and 0 means "almost always". Points are collected and divided by the number of items filled to obtain the total score. Higher scores indicate better health-related quality of life.
Measured: 2 months
The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory
The Turkish version of the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) were used to measure anxiety and depression levels of caregivers of children with CP. Both scales consist of 21 question and scored between 0-3. The highest score is 63.Higher scores indicate more severe anxiety or depression of an individual.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start25 Oct 2019
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre CENGIZ, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134533
- Sponsor's protocol ID
- Feeding Types in CP
- Status last verified
- Jan 2020
- First submitted
- 17 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Functional Level and Quality of Life According to Feeding Types in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04134533
- Acronym / sponsor ID
- Feeding Types in CP
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 22 Oct 2019 (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 aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy.
Detailed description
The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. Children will be divided into two groups: children with oral feeding and children with non-oral feeding, according to Functional Oral Intake Scale. Gross Motor Function Classification System will be used for classify children according to gross motor function, Gross Motor Function Measurement will be used for evaluate gross motor functions, and parent-reported Pediatric Quality of Life Inventory will be used for evaluate quality of life of children. To measure caregivers' anxiety and depression levels will be assessed by using Beck Depression Inventory and Beck Anxiety Inventory. Parametric or non-parametric tests will be applied according to the variables distribution. Through this analyses, determination of the difference between feeding type groups and other categorical and continuous variables will be decided.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Feeding Group | – | Other: Gross Motor Function MeasurementChildren with cerebral palsy who fed orally according to the Functional Oral Intake Scale |
| Non-Oral Feeding Group | – | Other: Gross Motor Function MeasurementChildren with cerebral palsy who fed non-orally according to the Functional Oral Intake Scale. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Cerebral Palsy
Key inclusion criteria (4 listed)
- Children who were diagnosed with CP
- Aged between 5-18 years
- Must have cooperation
- Feed by orally or non-orally
Key exclusion criteria (3 listed)
- Having other accompanying neurodegenerative diseases.
- Acute respiratory tract infection
- Complications of enteral feeding
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 |
|---|---|---|
| Gross Motor Function MeasurementAlso: Pediatric Quality of Life Inventory, Beck Anxiety Inventory, Beck depression Inventory, Gross Motor Function Classification SystemThese instruments will be used for determine the gross motor functional level and quality of life of the children with cerebral palsy and anxiety, depression levels of caregivers. | Other | Non-Oral Feeding Group, Oral Feeding Group |
Primary outcome
Gross motor Function Measurement
Time frame: 2 months
The Gross Motor Function Measurement (GMFM) is an observational clinical tool to evaluate motor function of children with CP. It has five basic sections that evaluate motor function in detail, including lying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping, with a total of 88 items. Each evaluation is scored according to the level of achieving gross motor function without considering the quality of movement. While children performing each task in the GMFM, a physiotherapist scored each evaluation on a Likert scale between 0 to 3, of which 0 means 'Does not initiate' and 3 means 'Completes'.
3 secondary outcomes
Gross Motor Function Classification System
Time frame: 2 months
Pediatric Quality of Life Inventory
Time frame: 2 months
The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory
Time frame: 2 months
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 18 Jan 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 3 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 18 Jan 2020. 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?
Gross motor Function Measurement (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.