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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00863070
First received: March 16, 2009
Last updated: March 16, 2017
Last verified: March 2017
  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 ]

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 ]
  • Pediatric Outcomes Data Collection Instrument (PODCI) [ Time Frame: 2 weeks ]

Enrollment: 6
Study Start Date: April 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (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   (Child, Adult)
Sexes Eligible for Study:   All
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

Locations
United States, Connecticut
Center for Motion Analysis
Farmington, Connecticut, United States, 06032
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Study Director: Katherine W Herbst, M.Sc Connecticut Children's Medical Center
  More Information

Responsible Party: 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: March 16, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Bladder Exstrophy
Urogenital Abnormalities
Urinary Bladder Diseases
Urologic Diseases
Congenital Abnormalities
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017