Möbius SequenceMobiusNCT00856531
Impairments of Oral Language in Mobius Syndrome
An observational study of Möbius Sequence, run by Fortaleza University.
Trial summary
The Möbius syndrome constitutes a congenital disorder classically caused by genetic and environmental factors. The clinical manifestations include lesion of the facial and abducens nerves associated with limb malformations specially club foot. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Möbius Sequence
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jan 2003
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará, Brazil.
Who may be able to join
- Möbius syndrome
- Age ranging from two to thirteen years old.
Who cannot join
- Others diseases with impact in oral language.
About this study
Official title: Impairments of Oral Language in Subjects With the Möbius Sequence
The Möbius syndrome constitutes a congenital disorder classically caused by genetic and environmental factors. The clinical manifestations include lesion of the facial and abducens nerves associated with limb malformations specially club foot. The speech-language manifestations include compromise of oral and deglutition, speech and language functions, secondary to cranial nerves lesions and mental retardation. The language compromise in this disorder is still not well known. In this way, the main objective of this study is to characterize the oral language in a population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará. The present work is a descriptive study of a cross-sectional design conducted from February to December/2002, using a clinical evaluation of language components including morphology, syntax, semantics and pragmatics. The investigators identified exclusive speech involvement in 20,0% of the subjects, language disturbance in 46,7%, speech and language disturbance in 13,3% and oral language involvement in 26,7%. The investigators conclude that the language disturbance in the Möbius syndrome presents with a variable compromise of all oral language components. The delay in linguistical development, incomprehensive speech and the deficit of constructions of sentences and narrations are constant.
Read the detailed description
In this way, the main objective of this study is to characterize the oral language in a population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará. The present work is a descriptive study of a cross-sectional design conducted from February to December/2002, using a clinical evaluation of language components including morphology, syntax, semantics and pragmatics.
- Conditions
- Möbius Sequence
- Keywords
- Möbius syndrome, Language, Speech, Language and Hearing Sciences
- Medical subject headings
- Mobius Syndrome, Language, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described | |
| 3 | Not described | |
| 4 | Not described | |
| 5 | Not described | |
| 6 | Not described | |
| 7 | Not described | |
| 8 | Not described | |
| 9 | Not described | |
| 10 | Not described | |
| 11 | Not described | |
| 12 | Not described | |
| 13 | Not described | |
| 14 | Not described | |
| 15 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2009 (estimated)
- Study startJan 2002
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Möbius SequenceStudies 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
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00856531
- Sponsor's protocol ID
- mobius syndrome
- Acronym
- Mobius
- Status last verified
- Mar 2009
- First submitted
- 4 Mar 2009
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impairments of Oral Language in Subjects With the Möbius Sequence
- ClinicalTrials.gov ID
- NCT00856531
- Acronym / sponsor ID
- Mobius / mobius syndrome
- Conditions
- Möbius Sequence
- Keywords
- Möbius syndrome, Language, Speech, Language and Hearing Sciences
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 5 Mar 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 Möbius syndrome constitutes a congenital disorder classically caused by genetic and environmental factors. The clinical manifestations include lesion of the facial and abducens nerves associated with limb malformations specially club foot. The speech-language manifestations include compromise of oral and deglutition, speech and language functions, secondary to cranial nerves lesions and mental retardation. The language compromise in this disorder is still not well known. In this way, the main objective of this study is to characterize the oral language in a population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará. The present work is a descriptive study of a cross-sectional design conducted from February to December/2002, using a clinical evaluation of language components including morphology, syntax, semantics and pragmatics. The investigators identified exclusive speech involvement in 20,0% of the subjects, language disturbance in 46,7%, speech and language disturbance in 13,3% and oral language involvement in 26,7%. The investigators conclude that the language disturbance in the Möbius syndrome presents with a variable compromise of all oral language components. The delay in linguistical development, incomprehensive speech and the deficit of constructions of sentences and narrations are constant.
Detailed description
In this way, the main objective of this study is to characterize the oral language in a population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará. The present work is a descriptive study of a cross-sectional design conducted from February to December/2002, using a clinical evaluation of language components including morphology, syntax, semantics and pragmatics.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
| 3 | – | – |
| 4 | – | – |
| 5 | – | – |
| 6 | – | – |
| 7 | – | – |
| 8 | – | – |
| 9 | – | – |
| 10 | – | – |
| 11 | – | – |
| 12 | – | – |
| 13 | – | – |
| 14 | – | – |
| 15 | – | – |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from both sexes, seen in one of the three main center for genetic diagnosis in the state of Ceará, Brazil.
Key inclusion criteria (2 listed)
- Möbius syndrome
- Age ranging from two to thirteen years old.
Key exclusion criteria (1 listed)
- Others diseases with impact in oral language.
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 5 Mar 2009.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Möbius Sequence, 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 2 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 5 Mar 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 5 Mar 2009.