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

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 Overview

• Status: Completed
• Conditions: Bladder Exstrophy

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06032
      • Center for Motion Analysis
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bladder Exstrophy Patients; Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gait Testing and Analysis	2 Weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 16, 2009
• First Submitted That Met QC Criteria: March 16, 2009
• First Posted (Estimate): March 17, 2009

Study Record Updates

• Last Update Posted (Actual): March 20, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: anatomy; urinary bladder disease; Bladder exstrophy; Abnormal gait; urogenital abnormalities
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urogenital Abnormalities; Congenital Abnormalities; Bladder Exstrophy
• Other Study ID Numbers: 09-003 (Other Identifier: Memorial Sloan-Kettering Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO