Stereophotogrammetry of the Torso in Healthy Individuals and Patients With Scoliosis, Chest Wall Deformations, or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Output variables provided by the Matlab stereophotogrammetry analysis program
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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).
排除标准
- •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.
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers without scoliosis or obesity
Obesity
Healthy volunteers with obesity
Scoliosis
Healthy volunteers with scoliosis but no obesity
结局指标
主要结局
Output variables provided by the Matlab stereophotogrammetry analysis program
时间窗: 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
时间窗: 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.
次要结局
- stand and reach(after accrual of 50 subjects, 100 subjects, and all subjects)
- chest circumference(after accrual of 50 subjects, 100 subjects, and all subjects)
- rib symmetry(after accrual of 50 subjects, 100 subjects, and all subjects)
- WHR(after accrual of 50 subjects, 100 subjects, and all subjects)
- leg length discrepancies(after accrual of 50 subjects, 100 subjects, and all subjects)
- pectus carinatum(after accrual of 50 subjects, 100 subjects, and all subjects)
- pectus excavatum(after accrual of 50 subjects, 100 subjects, and all subjects)
- BMI(after accrual of 50 subjects, 100 subjects, and all subjects)
- pelvic obliquity(after accrual of 50 subjects, 100 subjects, and all subjects)
- AP chest diameter(after accrual of 50 subjects, 100 subjects, and all subjects)
- Adam s forward bending test(after accrual of 50 subjects, 100 subjects, and all subjects)
- Schober test(after accrual of 50 subjects, 100 subjects, and all subjects)
- finger-floor test(after accrual of 50 subjects, 100 subjects, and all subjects)