Rett SyndromeNCT00630422
Functional Abilities in Rett Syndrome
An observational study of Rett Syndrome, run by Faculdades Metropolitanas Unidas at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate and determinate the functional abilities in Rett syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rett Syndrome
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2006to Dec 2006
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study investigated only patients with Rett syndrome that matched the criteria for the classic form of the disease
Who may be able to join
- Patients with Rett syndrome that matched the criteria for the classic form of the disease
Who cannot join
- Any other disease;
- Rett syndrome associated with other disease
- Rett syndrome that not that matched the criteria for the classic form of the disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate and determinate the functional abilities in Rett syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI).
Read the detailed description
Rett syndrome (RS) is a progressive neurological disturbance of genetic cause that affects females almost exclusively. It is caused by mutations, usually sporadic, of the MECP2 gene located in the X chromosome. In consequence to the serious cognitive and motor compromise, the RS patients have great difficulty in accomplishing day-to-day tasks. The objective of this work is to evaluate the functional abilities in RS to help therapists in theirs treatments programs.
- Conditions
- Rett Syndrome
- Keywords
- Rett Syndrome, Selfcare, Mobility limitation, Interpersonal relations, This study avaliated patients with Rett Syndrome
- Medical subject headings
- Rett Syndrome, Mobility Limitation
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 |
|---|---|---|
| 64 | All Patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2006
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rett SyndromeStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdades Metropolitanas Unidas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Investigators
- Carlos BM Monteiro, PhD, Principal investigator, Faculdades Metropolitanas Unidas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630422
- Sponsor's protocol ID
- monteiro
- Other IDs
- monteiro1
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Abilities in Rett Syndrome
- ClinicalTrials.gov ID
- NCT00630422
- Acronym / sponsor ID
- monteiro
- Conditions
- Rett Syndrome
- Keywords
- Rett Syndrome, Selfcare, Mobility limitation, Interpersonal relations, This study avaliated patients with Rett Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Faculdades Metropolitanas UnidasUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Feb 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Mar 2008 (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 evaluate and determinate the functional abilities in Rett syndrome conforming to the established Pediatric Evaluation of Disability Inventory (PEDI).
Detailed description
Rett syndrome (RS) is a progressive neurological disturbance of genetic cause that affects females almost exclusively. It is caused by mutations, usually sporadic, of the MECP2 gene located in the X chromosome. In consequence to the serious cognitive and motor compromise, the RS patients have great difficulty in accomplishing day-to-day tasks. The objective of this work is to evaluate the functional abilities in RS to help therapists in theirs treatments programs.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 64 | – | –All Patients |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study investigated only patients with Rett syndrome that matched the criteria for the classic form of the disease
Key inclusion criteria (1 listed)
- Patients with Rett syndrome that matched the criteria for the classic form of the disease
Key exclusion criteria (3 listed)
- Any other disease;
- Rett syndrome associated with other disease
- Rett syndrome that not that matched the criteria for the classic form of the disease
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 7 Mar 2008.
- alread publishedLink provided by the sponsor.
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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.
Carlos BM Monteiro, PhD principal investigator
Faculdades Metropolitanas Unidas
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 Rett Syndrome, run by Faculdades Metropolitanas Unidas at 1 site in Brazil.
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 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 7 Mar 2008. 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 Brazil. 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.
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 7 Mar 2008.