跳至主要内容
临床试验/NCT04413162
NCT04413162已完成不适用

Measurement of Shoulder Range of Motion Using Microsoft Kinect 2.0 in Patients Undergoing Ultrasound-guided Capsular Distension for Adhesive Capsulitis

University of California, Davis2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
change in shoulder range of motion

研究概览

简要总结

This study will compare shoulder range of motion assessment using the Kinect motion tracking system vs goniometer in patients with adhesive capsulitis (frozen shoulder) undergoing ultrasound-guided capsular distention procedures (standard of care).

The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

详细描述

The study will be a single-center, investigator-initiated protocol to assess the reliability of the Kinect Motion Analysis 2.0 Motion Tracking System for Range Of Motion (ROM) assessment in patients with Shoulder Adhesive Capsulitis undergoing ultrasound guided capsular distention procedures (standard of care for adhesive capsulitis). Secondarily, the study will describe the relationship between range of motion of the shoulder girdle in the four quadrants of normalized reachable workspace by the Kinect 2.0, PROMIS person-reported outcome scores for pain, pain interference and function (general mobility and upper extremity function), and VAS pain scores.

Study participants are anticipated to remain in the study for 12 weeks: an initial visit followed by 6- and 12-week follow up visits. Given the nature of scheduling appointments in medical clinics, 12 weeks is an approximation; the actual duration may occasionally be 1-2 weeks longer if needed to successfully complete the follow-up visit.

The investigators hypothesize that, for shoulder adhesive capsulitis, the Kinect Motion Analysis 2.0 system will provide reliable results in a shorter and more efficient amount of time in comparison to traditional goniometer methods.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • diagnosis of limited ROM due to adhesive capsulitis
  • duration of symptoms of ≥ 3 months
  • persistent functional limitation (defined as either limitations occupationally, in independent activities of daily living, or activities of daily living)
  • X-rays and MRI excluding alternative diagnosis
  • age 18 years or older.

排除标准

  • prior shoulder surgery on the affected side
  • complete rotator cuff tear (based on clinical history, examination, and imaging) or planned surgical intervention on the affected side
  • ipsilateral subacromial injection within the last 3 months
  • autoimmune or rheumatologic disease affecting the joints
  • lack of scheduled same-day physical therapy appointment
  • inability to complete follow-up appointments or surveys
  • inability to provide informed consent
  • symptomatic glenohumeral or acromioclavicular pathology
  • referred pain from the neck or internal organs
  • generalized myofascial pain syndrome

结局指标

主要结局

change in shoulder range of motion

时间窗: 12 weeks

measured in degrees (high number of degrees = better range of motion)

次要结局

  • PROMIS score - upper extremity(12 weeks)
  • VAS score(12 weeks)
  • DASH score(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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