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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
Gender: Male & Female
Min Age: 2
Max Age: NA

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Anthropometry;
Stereophotogrammetry;
Torso

Recruitment Keyword(s)

Spinal Deformity;
Chest Wall Deformity;
Overweight;
Obese;
Healthy Volunteer;
HV

Condition(s)

Bone Diseases;
Obesity;
Healthy

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

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


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Citations:

Haller JA Jr, Kramer SS, Lietman SA. Use of CT scans in selection of patients for pectus excavatum surgery: a preliminary report. J Pediatr Surg. 1987 Oct;22(10):904-6.

Schelbert KB. Comorbidities of obesity. Prim Care. 2009 Jun;3 (2):271-85.

Kissebah AH, Vydelingum N, Murray R, Evans DJ, Hartz AJ, Kalkhoff RK, Adams PW. Relation of body fat distribution to metabolic complications of obesity. J Clin Endocrinol Metab. 1982 Feb;54(2):254-60.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Scott M. Paul, M.D.
National Institutes of Health Clinical Center (CC)
BG 10-CRC RM 1-1469
10 CENTER DR
BETHESDA MD 20814
(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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