FES Cycling Cost-Effectiveness Analysis in Rehabilitation for Persons Affected by Complete Spinal Cord Injury, an Experience From Two Italian Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Thigh Circumferences
研究概览
简要总结
20 patients were recruited by two hospitals (AOUP and AOUC) in Italy from January 2015 to January 2018. The participants have been addressed to two different groups: the ones recruited by the AOUP were submitted to an experimental protocol of rehabilitation with FES Cycling, the ones recruited by the AOUC were submitted to a standard protocol of manual mobilization.
The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, while the secondary outcomes were the muscle tone evaluated with Modified Ashworth Scale (MAS) and the sensation of pain registered with International Spinal Cord Injury - Pain Basic Data Set (ISCI-P).
From these outcomes the Quality Adjusted Life Years (QALYs) was obtained. The costs of the two treatments were calculated through a consultation process with the Competent Offices of the two hospitals. The QALYs and the costs were used to calculate the Incremental Cost-Effectiveness Ratio (ICER) in order to verify the cost-effectiveness ratio of the two treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complete spinal cord injury
- •loss of gait function
- •any episode of autonomic dysreflexia
- •any important range of motion limitation to hips, knees or ankles
- •eccitability of the muscles
- •FES tollerability
排除标准
- •cognitive deficits
- •psychiatric diseases
- •recent fractures
结局指标
主要结局
Thigh Circumferences
时间窗: 3 years
The primary outcome was the thigh circumferences measured at 4 different levels (5-10-15-20 cm) from the superior margin of the patella, the raging of the improvement could be from 0 to 50 cm
Incremental Cost-Effectiveness Ratio
时间窗: 3 years
QALYs/costs of the two treatments, the ICER could variate from -100'000 to 100'000 QALYs/€
次要结局
- Quality Adjusted Life Years (QALYs)(3 years)
- Costs(3 years)
- Muscle tone(3 years)
- Sensation of pain(3 years)
研究者
Matteo Olivieri
Principal Investigator
Azienda Ospedaliero, Universitaria Pisana