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临床试验/NCT02357914
NCT02357914Unknown不适用

Freehand Ultrasound to Evaluate Scapular Kinematics in People With Paraplegia

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Scapulothoracic joint range of motion, maximum, and minimum position

研究概览

简要总结

Shoulder pain is very common in people with spinal cord injury (SCI). Persons with high-level paraplegia have higher chances to suffer shoulder pain and injury than those with lower-level paraplegia due to the shoulder muscle imbalance. As people with SCI overuse the shoulder during routine daily activities, the onset of pain or injury lead to increased healthcare expenses, limitation in activity, depression, decreased participation, and reduced quality of life. One of the main reasons of shoulder pain is believed to have a altered scapular movement. To clarify the mechanism of the shoulder pain and injury, comprehensive understanding of three-dimensional scapular kinematics is required. Ultrasound is a low-cost and non-invasive imaging system and has been used to diagnose the shoulder pain and injury in individuals with SCI. A freehand ultrasound (FUS) combining ultrasound with motion capture system to evaluate scapular movement was developed and presented favorable results in able-bodied population. The purpose of this study is to compare the FUS and widely used skin-based method against a radiographic based gold standard in people with paraplegia, and to elucidate the relationship among scapular movement and shoulder pain, pathology. This study will also allow us to gain more understanding of how level of injury influences the scapular behavior during functional activities. The investigators believe more severe shoulder pain and pathology will be associated with greater abnormal scapular movement. The investigators also believe that people with high-level paraplegia will have greater scapular abnormality than people with low-level paraplegia during arm elevation and weight relief raise tasks. By completing this study, the investigators will expect to deliver a reliable and valid tool to evaluate scapular movement and gain a better understanding how the altered scapular movement is related to shoulder pain and pathology. The investigators will also learn how the level of injury affects the scapular behavior during functional activities. The results of this study may help the shoulder pain management leading to the improvement in the quality of life of individuals with SCI.

详细描述

Specific Aims:

Aim 1: Compare the freehand ultrasound (FUS) and skin-based markers methods with a well-established and accurate dynamic biplanar fluoroscopy combined with model-based tracking techniques to evaluate scapular kinematics.

Hypothesis 1: Throughout the arm elevation and weight relief raise, FUS measurements will have lower standard error of measurement, greater intra-rater repeatability, and better agreement with biplanar fluoroscopy techniques than skin-based method for scapular tilting, upward rotation, and external rotation.

Aim 2: Establish the convergent validity of FUS and skin-based markers method by describing the relationship between scapular kinematics and established measures of shoulder pain and pathology.

Hypothesis 2: Individuals with paraplegia diagnosed with more severe shoulder pain and signs of shoulder pathology will have reduced scapular posterior tilt, upward rotation, and external rotation during arm elevation and weight relief raise tasks compared to those with less shoulder pain and pathology.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above 18 years old
  • Have paraplegia as a result of a spinal cord injury morn than one year;
  • Able to perform push-ups independently and raise the arm above the head;
  • Self-propel a manual wheelchair as the primary means of mobility

排除标准

  • Have history of fractures or dislocations in the shoulder, elbow, or wrist from which you have not fully recovered;
  • Have upper limb pain as a result of a complex regional pain syndrome;
  • Have a implant or pacemaker within the torso or upper arm;
  • Pregnant female.

结局指标

主要结局

Scapulothoracic joint range of motion, maximum, and minimum position

时间窗: Two hours

Anterior/posterior tilting, protraction/retraction, lateral/medical rotation

次要结局

  • Shoulder pathology score(15 minutes)
  • Wheelchair User's Shoulder Pain Index(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasin Dhaher

Principal Investigator

Shirley Ryan AbilityLab

研究点 (1)

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