跳至主要内容
临床试验/NCT00863070
NCT00863070已完成不适用

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

Connecticut Children's Medical Center2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2
主要终点
Gait Testing and Analysis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject was seen at CCMC for bladder exstrophy between January 2002 and December
  • 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.

排除标准

  • Subject was not seen at CCMC for bladder exstrophy between January 2002 and December
  • 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.

结局指标

主要结局

Gait Testing and Analysis

时间窗: 2 Weeks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验