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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00863070

Acronym

Gait

Enrollment

Registered

2009-03-17

Start date

2009-04-30

Completion date

2013-03-31

Last updated

2017-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Exstrophy

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Gait Testing and Analysis	2 Weeks

Secondary

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

Countries

United States

Outcome results