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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bladder Exstrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bladder Exstrophy Patients

Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Subject was seen at CCMC for bladder exstrophy between January 2002 and December 2010.
2. Subject is four years of age or older at time of enrollment.
3. Subject has the ability to walk.
4. Subject has not had gait testing performed.
5. Subject provides Informed Consent and HIPAA Authorization.

Exclusion Criteria

1. Subject was not seen at CCMC for bladder exstrophy between January 2002 and December 2010.
2. Subject under four years of age at time of enrollment.
3. Subject does not have the ability to walk.
4. Subject had prior gait testing performed.
5. Subject not willing to provide Informed Consent and HIPAA Authorization.

Minimum Eligible Age

4 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No