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

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.

- 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.