Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bone Diseases
  • Healthy Volunteers
  • Obesity
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Cross-Sectional

Participation Requirements

Age
Between 2 years and 125 years
Gender
Both males and females

Description

OBJECTIVE: The primary objective of this project is to determine which outcome measures derived from analysis of SP images are reliable within the healthy population and can distinguish between healthy volunteers and those with scoliosis, chest wall deformities, and obesity. Secondary objectives inc...

OBJECTIVE: The primary objective of this project is to determine which outcome measures derived from analysis of SP images are reliable within the healthy population and can distinguish between healthy volunteers and those with scoliosis, chest wall deformities, and obesity. Secondary objectives include comparing SP outcome measures with clinical and radiographic measures to test concurrent validity and to determine if the SP outcome measures correlate with clinical and radiographic measures taken over time. The ultimate goal is to develop SP as a measurement tool to be employed in clinical research involving the study of scoliosis, rib and chest deformities and the truncal distribution of adiposity. STUDY POPULATION: The population for this study consists of healthy volunteers, persons with scoliosis and/or chest wall deformities, and persons with obesity. Men and women of all races, ethnicities, and ages greater than two years may participate. DESIGN: This project will be carried out in three phases. In Phase I, we will analyze images of healthy volunteers captured by the SP scoliosis and chest-wall deformity ( scoliosis ) software to identify the outcome measures that show minimal or no variance. We will also examine if healthy volunteers gender, age, height, and BMI contribute to the differences of these outcome measures. In Phase IIa, images captured from subjects with scoliosis and/or chest wall deformities will be processed by scoliosis software to determine the set of meaningful variables (those that show significant differences between the two populations). In Phase IIb, images captured of healthy volunteers will be processed using obesity software to determine the set of variables showing minimal or no variance among the data from healthy volunteers when controlling for the effects of potential confounders. Variables that continue to have minimal or no variance will be considered meaningful with respect to obesity analysis software. Those variables achieved from obesity image analysis will be compared to the set from the healthy volunteers to determine which variables show significant differences between the healthy volunteer and obese subjects. In Phase III, healthy participants, scoliosis/chest wall deformity, and obesity participants who are scheduled to return to NIH as part of another NIH protocol will be invited to return for yearly re-imaging up to a total of five years in order to analyze changes over time and compare them with concurrent radiographic measures. OUTCOME MEASURES: The purpose of the study is to develop outcome measures for use in future research. These outcome measures will be developed from software which analyzes images derived from the stereophotogrammetry system.

Tracking Information

NCT #
NCT01352949
Collaborators
Not Provided
Investigators
Principal Investigator: Scott M Paul, M.D. National Institutes of Health Clinical Center (CC)