Cerebral PalsyTOXSIALONCT02797106
Management of Drooling in Children With Cerebral Palsy in France
An observational study of Cerebral Palsy and Pathological Drooling, run by Hospices Civils de Lyon.
Trial summary
The study is a transversal, observational, descriptive survey of the practices and opinions of health professionals carried out nationally across France that aims to characterize children with cerebral palsy and pathological drooling and to describe care pathways, assessment and treatment of drooling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy, Pathological Drooling
- What is being tested?
- Practice survey of health professionals
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: health care professionals potentially involved in assessment and/or treatment of drooling in children with Cerebral Palsy.
Who may be able to join
- health professional known to assess and/or treat drooling
- health professional known to assess and/or treat children with Cerebral Palsy
- health professional exercising in France
Who cannot join
- health professional with an inactive e-mail address
About this study
Official title: Management of Drooling in Children With Cerebral Palsy: A French Survey of the Practices and Opinions of Health Professionals
The study is a transversal, observational, descriptive survey of the practices and opinions of health professionals carried out nationally across France that aims to characterize children with cerebral palsy and pathological drooling and to describe care pathways, assessment and treatment of drooling.
- Conditions
- Cerebral Palsy, Pathological Drooling
- Being tested
- Practice survey of health professionals
- Keywords
- Drooling, Cerebral palsy, Botulinium toxin, Practice survey of health professionals, Children
- Medical subject headings
- Cerebral Palsy, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice survey of health professionalsOther
Survey of the practices and opinions of health care professionals to describe care pathways, assessment and treatment of drooling in children with cerebral palsy
| Study group | Role | What they receive |
|---|---|---|
| health care professionals | health care professionals potentially involved in assessment and/or treatment of drooling in children with Cerebral Palsy. Receives: Other: Practice survey of health professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on the assessment and treatment of drooling in children with Cerebral Palsy
Questionnaire will measure practices of health professionals involved in care pathways, assessment and treatment of drooling in children with Cerebral Palsy.
Measured: Day 1 (At the time of the questionnaire mailing to the professionals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
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 Hospices Civils de LyonThe 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
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle CHALEAT-VALAYER, MD, Principal investigator, CMCR des Massues -Croix Rouge Française, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797106
- Sponsor's protocol ID
- D21660
- Acronym
- TOXSIALO
- Status last verified
- May 2016
- First submitted
- 31 May 2016
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Drooling in Children With Cerebral Palsy: A French Survey of the Practices and Opinions of Health Professionals
- ClinicalTrials.gov ID
- NCT02797106
- Acronym / sponsor ID
- TOXSIALO / D21660
- Conditions
- Cerebral Palsy, Pathological Drooling
- Keywords
- Drooling, Cerebral palsy, Botulinium toxin, Practice survey of health professionals, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Jun 2016 (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 study is a transversal, observational, descriptive survey of the practices and opinions of health professionals carried out nationally across France that aims to characterize children with cerebral palsy and pathological drooling and to describe care pathways, assessment and treatment of drooling.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health care professionals | – | Other: Practice survey of health professionalshealth care professionals potentially involved in assessment and/or treatment of drooling in children with Cerebral Palsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- health care professionals potentially involved in assessment and/or treatment of drooling in children with Cerebral Palsy.
Key inclusion criteria (3 listed)
- health professional known to assess and/or treat drooling
- health professional known to assess and/or treat children with Cerebral Palsy
- health professional exercising in France
Key exclusion criteria (1 listed)
- health professional with an inactive e-mail address
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 |
|---|---|---|
| Practice survey of health professionalsSurvey of the practices and opinions of health care professionals to describe care pathways, assessment and treatment of drooling in children with cerebral palsy | Other | health care professionals |
Primary outcome
Questionnaire on the assessment and treatment of drooling in children with Cerebral Palsy
Time frame: Day 1 (At the time of the questionnaire mailing to the professionals)
Questionnaire will measure practices of health professionals involved in care pathways, assessment and treatment of drooling in children with Cerebral Palsy.
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 13 Jun 2016.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Emmanuelle CHALEAT-VALAYER, MD principal investigator
CMCR des Massues -Croix Rouge Française, Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Pathological Drooling, run by Hospices Civils de Lyon.
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 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 13 Jun 2016. 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.
What does the primary outcome measure?
Questionnaire on the assessment and treatment of drooling in children with Cerebral Palsy (time frame: Day 1 (At the time of the questionnaire mailing to the professionals)). 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 13 Jun 2016.