Bladder ExstrophyGaitNCT00863070
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
An observational study of Bladder Exstrophy, run by Connecticut Children's Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether patients who have undergone exstrophy closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This study is a descriptive analysis of the study cohort's gait patterns and pelvic structure. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Bladder Exstrophy
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Mar 2013
- 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 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Bladder exstrophy patients receiving follow-up services at Connecticutcmc Urology clinic.
Who may be able to join
- Subject was seen at CCMC for bladder exstrophy between January 2002 and December 2010.
- Subject is four years of age or older at time of enrollment.
- Subject has the ability to walk.
- Subject has not had gait testing performed.
- Subject provides Informed Consent and HIPAA Authorization.
Who cannot join
- Subject was not seen at CCMC for bladder exstrophy between January 2002 and December 2010.
- Subject under four years of age at time of enrollment.
- Subject does not have the ability to walk.
- Subject had prior gait testing performed.
- Subject not willing to provide Informed Consent and HIPAA Authorization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Motion Analysis
Farmington, Connecticut, 06032
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
The purpose of this study is to determine whether patients who have undergone exstrophy closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.
Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent closure demonstrate gait abnormalities.
Read more
Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) demonstrate gait abnormalities compared with a reference population.
Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) will have below normal functional survey scores.
- Conditions
- Bladder Exstrophy
- Keywords
- Bladder exstrophy, Abnormal gait, anatomy, urinary bladder disease, urogenital abnormalities
- Medical subject headings
- Bladder Exstrophy, Mobility Limitation, Urinary Bladder Diseases, Urogenital Abnormalities
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 |
|---|---|---|
| Bladder Exstrophy Patients | Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Testing and Analysis
Measured: 2 Weeks
Secondary outcomes (2)
Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age
Measured: 2 weeks
Pediatric Outcomes Data Collection Instrument (PODCI)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder ExstrophyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine W Herbst, M.Sc, Study director, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863070
- Sponsor's protocol ID
- 09-003
- Acronym
- Gait
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2009
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy
- ClinicalTrials.gov ID
- NCT00863070
- Acronym / sponsor ID
- Gait / 09-003
- Conditions
- Bladder Exstrophy
- Keywords
- Bladder exstrophy, Abnormal gait, anatomy, urinary bladder disease, urogenital abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 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 purpose of this study is to determine whether patients who have undergone exstrophy closure may be at risk for long-term orthopedic issues manifest by gait abnormalities. This study is a descriptive analysis of the study cohort's gait patterns and pelvic structure.
Specific Aim 1: to determine whether patients with classic bladder exstrophy who underwent closure demonstrate gait abnormalities.
Hypothesis 1: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) demonstrate gait abnormalities compared with a reference population.
Hypothesis 2: Patients undergoing closure of bladder exstrophy (with or without pelvic osteotomy) will have below normal functional survey scores.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder Exstrophy Patients | – | –Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy. |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Bladder exstrophy patients receiving follow-up services at Connecticutcmc Urology clinic.
Key inclusion criteria (5 listed)
- Subject was seen at CCMC for bladder exstrophy between January 2002 and December 2010.
- Subject is four years of age or older at time of enrollment.
- Subject has the ability to walk.
- Subject has not had gait testing performed.
- Subject provides Informed Consent and HIPAA Authorization.
Key exclusion criteria (5 listed)
- Subject was not seen at CCMC for bladder exstrophy between January 2002 and December 2010.
- Subject under four years of age at time of enrollment.
- Subject does not have the ability to walk.
- Subject had prior gait testing performed.
- Subject not willing to provide Informed Consent and HIPAA Authorization.
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
Gait Testing and Analysis
Time frame: 2 Weeks
2 secondary outcomes
Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age
Time frame: 2 weeks
Pediatric Outcomes Data Collection Instrument (PODCI)
Time frame: 2 weeks
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 20 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Katherine W Herbst, M.Sc study director
Connecticut Children's Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Exstrophy, run by Connecticut Children's Medical Center at 2 sites in United States.
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 5 inclusion and 5 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does the primary outcome measure?
Gait Testing and Analysis (time frame: 2 Weeks). 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 20 Mar 2017.