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

Sponsor

Connecticut Children's Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00863070

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Exstrophy

Study Design

Study Type:

Observational

Actual Enrollment :

6 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Bladder Exstrophy Patients Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.

Outcome Measures

Primary Outcome Measures

Gait Testing and Analysis [2 Weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
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.