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

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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Key information

Conditions

Bladder Exstrophy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

4 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Motion Analysis, Farmington, Connecticut, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Gait Testing and Analysis

Time frame: 2 Weeks

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

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Acronym: Gait

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Mar 17, 2009
Registry last updated: Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed