Cerebral PalsyCPNCT01031771
Clinical and Instrumental Evaluation of Swallowing in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Deglutition Disorders, run by Fortaleza University.
Trial summary
The purpose of this study is to correlate the alimentary consistencies and deglutition disorders in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Cerebral Palsy, Deglutition Disorders
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Nov 2009
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Cerebral Palsy diagnoses
Who may be able to join
- Children with Cerebral Palsy diagnoses were involved, independent from the pre, peri and postnatal factors and from the type of Cerebral Palsy
Who cannot join
- Children who presented oropharyngelarynx structural abnormality and/or impossibility to feed by oral way
About this study
The purpose of this study is to correlate the alimentary consistencies and deglutition disorders in children with cerebral palsy.
Read the detailed description
Cross-sectional and quantitative study with sample consisted of 50 children with cerebral palsy. The data collection consisted in detection of the main dysphagic manifestations in different consistency of food and types of cerebral palsy.
- Conditions
- Cerebral Palsy, Deglutition Disorders
- Keywords
- Cerebral Palsy, Deglutition, Deglutition disorders, Endoscopy
- Medical subject headings
- Cerebral Palsy, Deglutition Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startFeb 2009
- Study completionNov 2009
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.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Investigators
- Moisés A Queiroz, Graduate, Principal investigator, Fortaleza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031771
- Sponsor's protocol ID
- 105/09
- Acronym
- CP
- Status last verified
- Dec 2009
- First submitted
- 12 Dec 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Evaluation of Swallowing in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01031771
- Acronym / sponsor ID
- CP / 105/09
- Conditions
- Cerebral Palsy, Deglutition Disorders
- Keywords
- Cerebral Palsy, Deglutition, Deglutition disorders, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Nov 2009 (actual)
- First posted
- 15 Dec 2009 (estimated)
- 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 purpose of this study is to correlate the alimentary consistencies and deglutition disorders in children with cerebral palsy.
Detailed description
Cross-sectional and quantitative study with sample consisted of 50 children with cerebral palsy. The data collection consisted in detection of the main dysphagic manifestations in different consistency of food and types of cerebral palsy.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Cerebral Palsy diagnoses
Key inclusion criteria (1 listed)
- Children with Cerebral Palsy diagnoses were involved, independent from the pre, peri and postnatal factors and from the type of Cerebral Palsy
Key exclusion criteria (1 listed)
- Children who presented oropharyngelarynx structural abnormality and/or impossibility to feed by oral way
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
Not reported in the source record.
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 15 Dec 2009.
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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.
Moisés A Queiroz, Graduate principal investigator
Fortaleza University
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Deglutition Disorders, run by Fortaleza University.
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 1 inclusion and 1 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 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 15 Dec 2009.