Morquio's DiseasePhase 4NCT00609440
Morquio's Syndrome: a Case Study
A Phase 4 study testing physiotherapeutic treatment in people with Morquio's Disease, run by Clínica de Hidroterapia e Recuperacao Funcional.
Trial summary
OBJECTIVES: Relating about the benefits proportionated by the physiotherapeutic treatment for the patients that have the Morquio's syndrome. METHODS: This study intends to analyse a patient that presents this syndrome, describing the physiotherapeutic treatment that was proposed and the evolution clinical. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Morquio's Disease
- What is being tested?
- physiotherapeutic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to May 2007
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- The parents agreed with the study;
- The parents signed a consent term
Who cannot join
- The treatment disturbed the patient physically or emotionally;
- The parents didn't signed the consent term;
- The patient refused to be treated.
About this study
OBJECTIVES: Relating about the benefits proportionated by the physiotherapeutic treatment for the patients that have the Morquio's syndrome. METHODS: This study intends to analyse a patient that presents this syndrome, describing the physiotherapeutic treatment that was proposed and the evolution clinical.
- Conditions
- Morquio's Disease
- Being tested
- physiotherapeutic treatment
- Keywords
- Morquio's disease; physiotherapy; results
- Medical subject headings
- Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapeutic treatmentOther
Also called physiatry
At first, the patient was submitted to a conventional physiotherapeutic treatment and respiratory exercises; then, we gave emphasis to the motor development marks and to the march training; eventually, the kid was conducted to hydrotherapy.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | A single case study, of a patient that was submitted to a physiotherapeutic treatment. Receives: Other: physiotherapeutic treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2006
- Study completionMay 2007
Why it stopped: terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morquio's DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica de Hidroterapia e Recuperacao Funcional
- Sponsor type
- University, hospital or other
- Collaborators
- Integrated Faculty of Recife
- Investigators
- Maria do Carmo Pinto Neta, Post-graduated, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609440
- Sponsor's protocol ID
- mairabelo
- Other IDs
- MBelo
- Status last verified
- Jan 2008
- First submitted
- 25 Jan 2008
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morquio's Syndrome: a Case Study
- ClinicalTrials.gov ID
- NCT00609440
- Acronym / sponsor ID
- mairabelo
- Conditions
- Morquio's Disease
- Keywords
- Morquio's disease; physiotherapy; results
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Clínica de Hidroterapia e Recuperacao FuncionalUniversity, hospital or other
- Collaborators
- Integrated Faculty of Recife
- Study start
- Jan 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 7 Feb 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.
OBJECTIVES: Relating about the benefits proportionated by the physiotherapeutic treatment for the patients that have the Morquio's syndrome. METHODS: This study intends to analyse a patient that presents this syndrome, describing the physiotherapeutic treatment that was proposed and the evolution clinical.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Other: physiotherapeutic treatmentA single case study, of a patient that was submitted to a physiotherapeutic treatment. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The parents agreed with the study;
- The parents signed a consent term
Key exclusion criteria (3 listed)
- The treatment disturbed the patient physically or emotionally;
- The parents didn't signed the consent term;
- The patient refused to be treated.
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 |
|---|---|---|
| physiotherapeutic treatmentAlso: physiatryAt first, the patient was submitted to a conventional physiotherapeutic treatment and respiratory exercises; then, we gave emphasis to the motor development marks and to the march training; eventually, the kid was conducted to hydrotherapy. | Other | A |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
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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.
Maria do Carmo Pinto Neta, Post-graduated principal investigator
Employee
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing physiotherapeutic treatment in people with Morquio's Disease, run by Clínica de Hidroterapia e Recuperacao Funcional.
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 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: stopped early, as of the sponsor's last update on 20 Oct 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated). Results are not available in the source record.
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 20 Oct 2008.