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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Connecticut Children's Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00863070
First received: March 16, 2009
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition
Bladder Exstrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomechanical Assessment of Level Gait in Patient's Status Post Bladder Exstrophy

Resource links provided by NLM:


Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • Gait Testing and Analysis [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: April 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bladder Exstrophy Patients
Patients who receive follow-up care at Connecticut CMC urology clinic for bladder exstrophy.

  Eligibility

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863070

Contacts
Contact: John Makari, M.D. 860-545-9520 jmakari@ccmckids.org
Contact: Katherine W. Herbst, M.Sc. 860-545-9520 kherbst@ccmckids.org

Locations
United States, Connecticut
Center for Motion Analysis Recruiting
Farmington, Connecticut, United States, 06032
Contact: John Makari, M.D.    860-545-9520    jmakari@ccmckids.org   
Contact: Katherine W. Herbst, M.Sc.    860-545-9520    kherbst@ccmckids.org   
Sub-Investigator: Sylvia Ounpuu, M.Sc.         
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: John Makari, M.D.    860-545-9520    jmakari@ccmckids.org   
Contact: Katherine W. Herbst, M.Sc.    860-545-9520    kherbst@ccmckids.org   
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: John Makari, M.D. Connecticut Children's Medical Center
  More Information

No publications provided

Responsible Party: John Makari, M.D./Pediatric Urologist, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00863070     History of Changes
Other Study ID Numbers: 09-003
Study First Received: March 16, 2009
Last Updated: June 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Connecticut Children's Medical Center:
Bladder exstrophy
Abnormal gait
anatomy
urinary bladder disease
urogenital abnormalities

Additional relevant MeSH terms:
Bladder Exstrophy
Congenital Abnormalities
Urinary Bladder Diseases
Urogenital Abnormalities
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014