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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01352949
First received: May 11, 2011
Last updated: June 7, 2014
Last verified: November 2013
  Purpose

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.

Condition
Bone Diseases
Obesity
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Stereophotogrammetry of the Torso in Normal Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary objective is to determine which outcome measures derived from analysis of SP images are reliable among the healthy population and can distinguish between healthy volunteers and those with scoliosis, chest wall deformities, and obesit...

Secondary Outcome Measures:
  • Comparison of SP outcome measures with clinical and radiographic measures to test concurrent validity and to determine the extent to which the SP outcome measures correlate with clinical and radiographic measures taken over time.

Estimated Enrollment: 525
Study Start Date: April 2011
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 radiologically 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 show skeletal maturity), must present a previously obtained clinical standing film to provide radiological confirmation of scoliosis dated no more than 12 months prior to the study visit. No xrays will be done for research purposes.
      • Children must present a previously obtained clinical standing film to provide radiological confirmation of scoliosis dated no more than six months prior to the study visit. No xrays will be done for research purposes.
      • Volunteers with spinal surgery must show a post-operative film that shows that the instrumentation is intact and that desired spinal fusion has occurred. No xrays will be done for research purposes.
    • 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. 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 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.
  • 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 unable to tolerate stroboscopic camera flash

  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: NCT01352949

Contacts
Contact: Gayathri Prabhakar (301) 496-4733 prabhakarg@cc.nih.gov
Contact: Scott M Paul, M.D. (301) 496-4733 spaul1@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Scott M Paul, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01352949     History of Changes
Other Study ID Numbers: 110120, 11-CC-0120
Study First Received: May 11, 2011
Last Updated: June 7, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Anthropometry
Stereophotogrammetry
Torso
Spinal Deformity
Chest Wall Deformity
Overweight
Obese
Healthy Volunteer
HV

Additional relevant MeSH terms:
Bone Diseases
Obesity
Scoliosis
Musculoskeletal Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on August 25, 2014