Movement Analysis in Musculoskeletal Oncology: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 6 years
- •Diagnosis of primary and secondary tumors of the musculoskeletal system
- •Patients who will need to undergo surgery for bone resection or wide excision of soft tissue lesion, and/or radiation or drug treatments
- •Availability of follow-up data (for at least 6 months)
- •Written informed consent
排除标准
- •Inability to perform pre-post treatment assessment
结局指标
主要结局
Quality of life
时间窗: Baseline
To investigate any differences found using the two methods (quantitative/movement analysis technique versus "subjective"/qualitative technique) in changes in walking/motor characteristics in post-treatment versus pre-treatment. Patients will be monitored via a system of wearable sensors (OPAL 15) which send signals to a computer - station receiving. The system is equipped with 15 small, wireless devices and non-invasive, which contain the following sensors: i) triaxial accelerometer for measuring linear accelerations of the body segment; ii) triaxial gyroscope for measuring angular speeds; iii) triaxial magnetometer, essential for estimating the orientation of the segment in space corporeal. The system synchronously acquires data from each device and sends it via telemetry to one control unit that collects them and saves them in the local database of the computer used for the acquisition.
次要结局
未报告次要终点