Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Perceived Ease of Use and Usefulness
研究概览
简要总结
Correct performance of therapeutic lymphatic exercises has the potential to relieve lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast cancer survivors' quality of life and reduce the risk of lymphedema. Kinect-TOLF (Kinect-Enhanced The-Optimal-Lymph-Flow Training System) is an innovative intelligent Kinect-enhanced training system to teach patients to perform the lymphatic exercises correctly. The Kinect-TOLF training system is not a medical device but a computer/mobile and motion-sensor program that helps patients to perform the lymphatic exercises correctly. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. The goal of the proposed project is to evaluate the usability and feasibility of Kinect-TOLF.
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
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have received surgical treatment for breast cancer (Stage I-III), including mastectomy, lumpectomy, sentinel lymph node biopsy (SLNB), SLNB plus lymph node dissection or axillary lymph nodes dissection
- •Report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing
- •May or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation
- •Have history or no history of lymphedema or have or not been treated for lymphedema;
- •Able to speak and understand English since the proposed usability testing is designed to only test the English version of the intervention.
- •Women willing to come to the NYU Perlmutter Cancer Center for the research visit.
排除标准
- •Women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema;
- •Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions;
- •Women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (BMI) may not be possible with an impedance device according to the manufactures.
研究组 & 干预措施
Kinect-TOLF prototype
干预措施: Kinect-TOLF Training System (Behavioral)
结局指标
主要结局
The Perceived Ease of Use and Usefulness
时间窗: 12 Months
a tool to evaluate users' acceptance of a new information system with a strong reliability for perceived usefulness and perceived ease of use \[49-50\]. We used the modified eight-items with 5-point Likert Scales ranging from 2 (strongly agree) to -2 (strongly disagree) for this usability evaluation.
The Post Study System Usability Questionnaire
时间窗: 12 Months
originally is a 19-item survey instrument developed at IBM to assess user satisfaction with system usability on a scale ranging from 1 (strongly agree) to 7 (strongly disagree). We will use the modified 13-item tool from the original survey that focus on system usefulness and information quality (Lewis 1995). The survey consists of three subscales accounted for 87 percent of the total variance: system usefulness, information quality and interface quality. The overall reliability of the survey was 0.97, and ranged from 0.91 to 0.96 for the three subscales.
次要结局
未报告次要终点