Bone DiseasesNCT01352949
Stereophotogrammetry of the Torso in Healthy Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity
An observational study of Bone Diseases and Obesity, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Bone Diseases, Obesity, Healthy Volunteers
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Show all 12Show fewer
- 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).
Who cannot join
- Subjects unable to tolerate having points on the torso marked with a surgical ink marker
- Subjects with contact or respiratory isolation status
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Bone Diseases, Obesity, Healthy Volunteers
- Keywords
- Anthropometry, Stereophotogrammetry, Torso, Natural History
- Medical subject headings
- Bone Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers without scoliosis or obesity | |
| Obesity | Healthy volunteers with obesity | |
| Scoliosis | Healthy volunteers with scoliosis but no obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Output variables provided by the Matlab stereophotogrammetry analysis program
Measures derived from mathematical analysis of cross sections of the 3d torso computer model
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
Other variables calculated from the Matlab stereophotogrammetry output variables
Variables calculated by comparing and connecting the outputs of individual cross sectional analyses described above.
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
Secondary outcomes (13)
pelvic obliquity
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
AP chest diameter
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
Adam s forward bending test
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
rib symmetry
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
finger-floor test
physical parameters which will be measured in order to perform tests of concurrent validity for obesity
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
Schober test
physical parameters which will be measured in order to perform tests of concurrent validity for obesity
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
stand and reach
physical parameters which will be measured in order to perform tests of concurrent validity for obesity
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
WHR
physical parameters which will be measured in order to perform tests of concurrent validity for obesity
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
leg length discrepancies
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
pectus carinatum
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
chest circumference
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
pectus excavatum
physical parameters which will be measured in order to perform tests of concurrent validity for scoliosis/chest-wall deformities
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
BMI
physical parameters which will be measured in order to perform tests of concurrent validity for obesity
Measured: after accrual of 50 subjects, 100 subjects, and all subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study start2 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Galen O Joe, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352949
- Sponsor's protocol ID
- 110120
- Other IDs
- 11-CC-0120
- Status last verified
- 15 Sep 2026
- First submitted
- 11 May 2011
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereophotogrammetry of the Torso in Healthy Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity
- ClinicalTrials.gov ID
- NCT01352949
- Acronym / sponsor ID
- 110120
- Conditions
- Bone Diseases, Obesity, Healthy Volunteers
- Keywords
- Anthropometry, Stereophotogrammetry, Torso, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 2 Jun 2011 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers without scoliosis or obesity |
| Obesity | – | –Healthy volunteers with obesity |
| Scoliosis | – | –Healthy volunteers with scoliosis but no obesity |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
Key exclusion criteria (6 listed)
- Subjects unable to tolerate having points on the torso marked with a surgical ink marker
- Subjects with contact or respiratory isolation status
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Output variables provided by the Matlab stereophotogrammetry analysis 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.
13 secondary outcomes
pelvic obliquity
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
AP chest diameter
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
Adam s forward bending test
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
rib symmetry
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
finger-floor test
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
Schober test
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
stand and reach
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
WHR
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
leg length discrepancies
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
pectus carinatum
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
chest circumference
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
pectus excavatum
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
BMI
Time frame: after accrual of 50 subjects, 100 subjects, and all subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galen O Joe, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases and Obesity, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Output variables provided by the Matlab stereophotogrammetry analysis program (time frame: after accrual of 50 subjects, 100 subjects, and all subjects). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.