Protocol Details
Stereophotogrammetry of the Torso in Normal Individuals and Patients with Scoliosis, Chest Wall Deformations, or Obesity
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
11-CC-0120 |
Sponsoring Institute |
National Institutes of Health Clinical Center (CC) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Anthropometry; |
Recruitment Keyword(s) |
Spinal Deformity; |
Condition(s) |
Bone Diseases; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- 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.
Eligibility
INCLUSION CRITERIA:
a. 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.
b. Subjects must be able to stand independently for imaging. this limit enrollment to subjects 2 years of age and older.
c. Subjects must agree to capture of image of their bare torso above the waist
d. Healthy volunteers without scoliosis, 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).
e. 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.
f. 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.
EXCLUSION CRITERIA:
a. Subjects unable to cooperate with physical examination and pre-image measurements
b. Subjects unable to cooperate with imaging.
c. Subjects who cannot stand with arms raised for duration of imaging
d. Subjects unable to tolerate having points on the torso marked with a surgical ink marker
e. Subjects with contact or respiratory isolation status
f. 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.
g. Subjects with pacemakers or other electrical or conducting metal medical devices implanted in their torso will not be able to pariticipate in the normal volunteer and obesity groups due to contraindication to participation in bioelectric spectroscopy testing.
h. Subject 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 pariticiate in the normal volunteer and obesity groups because it will caus data distortion in the bioelectric spectroscopy testing.
i. Subjects who are unable to tolerate stroboscopic camera flash
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Scott M. Paul, M.D. National Institutes of Health Clinical Center (CC) National Institutes of Health BG 10-CRC RM 1-1469 MSC 1604 10 CENTER DR BETHESDA MD 20892-1604 (301) 496-4733 spaul1@mail.nih.gov |
Gayathri Prabhakar National Institutes of Health Clinical Center (CC) National Institutes of Health Building 10 Room 1-1469 10 Center Drive Bethesda, Maryland 20892 (301) 496-4733 prabhakarg@cc.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01352949
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