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

NCT00863070 | Completed

• 1 other identifier: 09-003
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Exstrophy

Keywords

Bladder exstrophy; Abnormal gait; anatomy; urinary bladder disease; urogenital abnormalities

Outcome Measures

Primary Outcomes (1)

• Gait Testing and Analysis

  2 Weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

Bladder Exstrophy Patients

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

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (2)

Center for Motion Analysis

Farmington, Connecticut, 06032, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Bladder Exstrophy; Mobility Limitation; Urinary Bladder Diseases; Urogenital Abnormalities

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine W Herbst, M.Sc

  Connecticut Children's Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 17, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)