Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.
研究概览
简要总结
The study will measure and compare range of motion (ROM), motion during simulated activities of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456), and TLSO (464).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI < 40
- •English speaking
- •Subjects who have read and signed IRB approved informed consent for this study
- •Of appropriate body size for back brace per instructions for use
排除标准
- •History of back pain or back injury requiring medical care within the previous 12 months
- •History of spinal surgery, physical or chiropractic therapy of the back
- •History of spinal spondylosis or osteoporosis
- •Currently Incarcerated
研究组 & 干预措施
Healthy subjects
Healthy subjects who meet the Inclusion/Exclusion.
干预措施: Aspen 456 (Device)
Healthy subjects
Healthy subjects who meet the Inclusion/Exclusion.
干预措施: DJO 464 (Device)
Healthy subjects
Healthy subjects who meet the Inclusion/Exclusion.
干预措施: Aspen 464 (Device)
Healthy subjects
Healthy subjects who meet the Inclusion/Exclusion.
干预措施: DJO 456 (Device)
结局指标
主要结局
Rotation angle in the transverse plane when reaching forwards and around an object with their right hand.
时间窗: Day 1
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Range of motion - Frontal plane
时间窗: Day 1
Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects bend their trunk relative to their pelvis laterally to the right and left in the frontal plane.
Range of motion - Transverse plane
时间窗: Day 1
Range of motion of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis laterally to the right and left in the transverse plane.
Range of motion in the frontal plane while walking on a level surface
时间窗: Day 1
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Flexion angle in the sagittal plane when reaching forwards and around an object with their right hand.
时间窗: Day 1
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Lateral angle in the frontal plane when reaching forwards and around an object with their left hand.
时间窗: Day 1
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Range of motion in the sagittal plane when returning to a seated position
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects move from an upright standing position to a seated position.
Range of motion in the sagittal plane while ascending stairs.
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Range of motion in the transverse plane while ascending stairs.
时间窗: Day 1
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Lateral angle in the frontal plane when reaching forwards and around an object with their right hand.
时间窗: Day 1
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their right hand
Extension - Sagittal plane
时间窗: Day 1
Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects extend their trunk relative to their pelvis in the sagittal plane.
Rotation angle while looking over shoulder
时间窗: Day 1
Maximum rotation angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rotate their trunk relative to their pelvis to look at an object placed 150 degrees behind them.
Range of motion in the sagittal plane when rising from a chair
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects rise from a chair.
Range of motion in the sagittal plane while walking on a level surface
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Range of motion in the transverse plane while walking on a level surface
时间窗: Day 1
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects walk across a level surface.
Range of motion in the sagittal plane while descending stairs.
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Range of motion in the frontal plane while descending stairs.
时间窗: Day 1
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Range of motion in the transverse plane while descending stairs.
时间窗: Day 1
Range of motion in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects descend a flight of four steps
Flexion angle in the sagittal plane when reaching when reach down to pick up a suitcase
时间窗: Day 1
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Flexion - Sagittal plane
时间窗: Day 1
Angle of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects flex their trunk relative to their pelvis in the sagittal plane.
Flexion angle in the sagittal plane when touching right hallux in a seated position
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to touch their right hallux while in a seated position.
Flexion angle in the sagittal plane when picking an object up from the floor
时间窗: Day 1
Range of motion in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forward and down to pick up a 85mm diameter object weighing 500grams from the floor from a standing position.
Range of motion in the frontal plane while ascending stairs.
时间窗: Day 1
Range of motion in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects ascend a flight of four steps
Flexion angle in the sagittal plane when reaching forwards and around an object with their left hand.
时间窗: Day 1
Flexion angle in the sagittal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Lateral angle in the frontal plane when reaching when reach down to pick up a suitcase
时间窗: Day 1
Lateral angle in the frontal plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
Rotation angle in the transverse plane when reaching forwards and around an object with their left hand.
时间窗: Day 1
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach forwards and around the back of a chair with their left hand
Rotation angle in the transverse plane when reaching when reach down to pick up a suitcase
时间窗: Day 1
Rotation angle in the transverse plane of the thorax relative to the pelvis will be measured in degrees using stereophotogrammetric techniques while subjects reach down to pick up a standard carry-on sized suitcase positioned to the right of their body with their right hand
次要结局
- Trunk stiffness and damping - back angle(Day 1)
- Trunk stiffness and damping - front angular acceleration(Day 1)
- Trunk stiffness and damping - front angular velocity(Day 1)
- Trunk stiffness and damping - back angular velocity(Day 1)
- Trunk stiffness and damping - right side angle(Day 1)
- Comfort(Day 1)
- Trunk stiffness and damping - front angle(Day 1)
- Trunk stiffness and damping - back angular acceleration(Day 1)
- Trunk stiffness and damping - right side angular velocity(Day 1)
- Trunk stiffness and damping - right side angular acceleration(Day 1)