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Stereophotogrammetry of the Torso in Healthy Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity

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ClinicalTrials.gov Identifier: NCT01352949
Recruitment Status : Recruiting
First Posted : May 12, 2011
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date May 11, 2011
First Posted Date May 12, 2011
Last Update Posted Date October 24, 2019
Actual Study Start Date June 2, 2011
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 22, 2019)
  • Output variables provided by the Matlab stereophotogrammetryanalysis program [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    Measures derived from mathematical analysis of cross sections of the 3d torso computer model
  • Other variables calculated from the Matlab stereophotogrammetry output variables [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    Variables calculated by comparing and connecting the outputs of individual cross sectional analyses described above.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01352949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 22, 2019)
  • pelvic obliquity [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • Adam's forward bending test [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • leg length discrepancies [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • pectus excavatum [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • pectus carinatum [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • AP chest diameter [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • chest circumference [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • rib symmetry [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
  • BMI [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for obesity
  • Schober test [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for obesity
  • finger-floor test [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for obesity
  • stand and reach [ Time Frame: after accrual of 50 subjects, 100 subjects, and all subjects ]
    physical parameters which will be measured in order to perform tests of concurrent validity for obesity
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stereophotogrammetry of the Torso in Healthy Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity
Official Title Stereophotogrammetry of the Torso in Normal Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity
Brief Summary

Background:

- Stereophotogrammetry (SP) uses four sets of digital cameras to generate a three-dimensional computer image. Unlike other types of evaluations which require radiation, SP only uses computer images to learn more about physical deformities such as scoliosis or about the placement of fat on the body. To refine the SP process, researchers are interested in collecting images and body data from individuals with skeletal structural problems such as scoliosis or chest wall deformities, individuals who are overweight or obese, and healthy volunteers.

Objectives:

- To use stereophotogrammetry to study different individual body types and refine existing imaging techniques.

Eligibility:

- Individuals at least 2 years of age who have spine, rib, or chest wall deformities; are overweight or obese (body mass index greater than 25); or are healthy volunteers.

Design:

  • Participants will be screened with a physical examination and medical history. The physical examination will include measurements of range of motion and joint mobility, torso width and length, and other observational data.
  • Healthy volunteers and participants in the obesity group will also have bioelectric spectroscopy (bioimpedance), which uses an additional machine to measure how fat is spread in different parts of the body.
  • After the physical examination has been completed, participants will have SP photographs taken. Participants will be asked to remove all clothing from the torso, stand with arms raised at the center of four cameras, and remain still while several images are taken. A complete image takes less than 1 second.
  • Participants with spine or rib deformities, or who are in the obesity group, may also volunteer to return for followup SP imaging, once a year for 5 years, to study progress over time.
Detailed 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 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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Bone Diseases
  • Obesity
  • Healthy Volunteers
Intervention Not Provided
Study Groups/Cohorts
  • Healthy Volunteers
    Healthy volunteers without scoliosis or obesity
  • Obesity
    Healthy volunteers with obesity
  • Scoliosis
    Healthy volunteers with scoliosis but no obesity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 11, 2011)
525
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

    • All subjects greater than 2 years of age, genders, and ethnicities will be eligible so long as they can cooperate with physical examination and imaging procedures.
    • Subjects must be able to stand independently for imaging. This limits enrollment to subjects 2 years of age and older.
    • Subjects must agree to capture of image of their bare torso above the waist
    • Healthy volunteers must be without scoliosis, or chest wall deformities, and with BMI below overweight range. For adults, BMI must be less than or equal to 25. BMI for children and adolescents will be corrected according to the guidelines designated by the Centers for Disease Control and Prevention found in Appendices 2 (boys) and 3 (girls).
    • Adults with BMI less than or equal to 25 and children and adolescents with adjust BMI below the overweight range AND with imaging confirmed scoliosis and/or chest wall deformities will be recruited from participants in NIH intramural protocols or referred by outside physicians and will be eligible to participate in phase IIa of the study.

      • Adults (subjects who are 18 years of age or older), must either present a previously obtained clinical standing scoliosis xray film dated no more than 12 months prior to the study visit or obtain a scoliosis series x-ray at the National Institutes of Health Clinical Center to provide confirmation of scoliosis. Therefore, xrays may be done for research purposes in adults if there is prior imaging indication but no scoliosis series xray films taken within the last 12 months.
      • Children must present a previously obtained clinical standing scoliosis film dated no more than six months prior to the study visit to provide radiological confirmation of scoliosis. No xrays will be done for research purposes.
      • Volunteers who have undergone spinal fusion surgery must show a postoperative film that shows that the instrumentation is intact and that desired spinal fusion has occurred. Xrays may be done for research purposes in adults if there is prior imaging indication but no scoliosis x-ray series films taken within the last 12 months.
    • Subjects with BMI greater than 25 (or for children and adolescents defined according to Centers for Disease Control and Prevention guidelines as "overweight") AND without deformities of the torso will be eligible to participate in phase IIb, the obesity portion of the study.
    • Subjects with deformities of the torso OR with BMI greater than 25 may be eligible to participate in Phase IIIa or IIIb and be followed yearly over the course of five years

      • Subjects with scoliosis and/or chest wall deformities that are followed over the course of the five years must provide clinically obtained films with at least a difference of a year between the current and previous films. In adults, if the curve changes, it is clinically indicated to get a follow-up film and subsequent scoliosis xray films may be taken at the NIH CC. Those who do not require clinical films cannot be included in the scoliosis/chest wall deformities group followed over time.
      • For subjects of BMI greater than 25, volunteers will be invited to be followed over time using SP if they have a change in their body composition over time (if they have not yet attained physical maturity, if they participate in weight loss program, or report a significant weight gain).

EXCLUSION CRITERIA:

  • Subjects unable to tolerate having points on the torso marked with a surgical ink marker
  • Subjects with contact or respiratory isolation status
  • Women of childbearing age who are found to be pregnant by urinalysis will not be able to participate as a healthy volunteer or in phase IIa (for scoliosis participants) if they require scoliosis xray series films to be taken at the NIH or in the obesity group due to contraindication to participation in bioelectric spectroscopy testing. Pregnant women may, however, participate in the scoliosis section of the study if they meet all relevant inclusion criteria. (but they cannot get xrays taken at the--NIH)
  • Subjects with pacemakers or other electrical or conducting metal medical devices implanted in their torso will not be able to participate in the normal volunteer and obesity groups due to contraindication to participation in bioelectric spectroscopy testing.
  • Subjects with electrical or conducting metal medical devices in their arms or legs that are not limited to one side of the body will not be able to participate in the normal volunteer and obesity groups because it will cause data distortion in the bioelectric spectroscopy testing.
  • Subjects who are unable to tolerate stroboscopic camera flash
  • Subjects who are employees/staff of the NIH Clinical Center Rehabilitation Medicine Department.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Katheryne Q Chun (301) 496-4733 katheryne.chun@nih.gov
Contact: Scott M Paul, M.D. (301) 496-4733 spaul1@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01352949
Other Study ID Numbers 110120
11-CC-0120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC)
Study Sponsor National Institutes of Health Clinical Center (CC)
Collaborators Not Provided
Investigators
Principal Investigator: Scott M Paul, M.D. National Institutes of Health Clinical Center (CC)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date October 21, 2019