Biomechanical Assessment of Level Gait in Patient's Statu... | NCT00863070

Studies
Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy

NCT00863070

Sponsor

Connecticut Children's Medical Center

Status

Completed

Last Update Posted

Mar 20, 2017Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Bladder Exstrophy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Mar 16, 2009

First Submission Date that Met QC Criteria

Mar 16, 2009

First Posted Date

Mar 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2017

Last Update Posted Date

Mar 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bladder Exstrophy Patients		Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gait Testing and Analysis		2 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Demographic Data:age;GA at birth; Prenatal DX;closure age;Pelvic osteotomies;Perioperative and late complications;Successful initial closure;Continence; Additional surgeries w/age		2 weeks
Pediatric Outcomes Data Collection Instrument (PODCI)		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Bladder exstrophy patients receiving follow-up services at Connecticutcmc Urology clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katherine W Herbst, M.Sc	Connecticut Children's Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Motion Analysis		Farmington	Connecticut	06032	United States
Connecticut Children's Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001746	Bladder Exstrophy
D051346	Mobility Limitation
D001745	Urinary Bladder Diseases
D014564	Urogenital Abnormalities

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D014570	Urologic Diseases

Browse Leaves

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Browse Branches

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