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

Bladder Exstrophy Clinical Trial

— Gait  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863070
• Other study ID #: 09-003
• Status: Completed
• Phase: N/A
• First received: March 16, 2009
• Last updated: March 16, 2017
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: March 2017
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Exstrophy

Locations

Country	Name	City	State
United States	Center for Motion Analysis	Farmington	Connecticut
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Testing and Analysis		2 Weeks
Secondary	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
Secondary	Pediatric Outcomes Data Collection Instrument (PODCI)		2 weeks