Revofit™ System and Residual Limb Pain in Amputee Patients : Multiple N-of-1 Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Pain change assessment
研究概览
简要总结
At the early stage of the amputation, the residual limb presents post-surgical fluctuations related to post-operative phase, which would need a frequent prosthetic adjustment. In most cases, the volume of residual limb is constant from 12 to 18 months after surgery. However, some daily fluctuations could appear due to an underlying vascular disease for example, which could be painful and impact the quality of life with a constant need of prosthetics adjustment. The goal of this study is to assess the effectiveness of a system-adjusted fitting in comparison with a standard fitting.
详细描述
With the " multiple N-of-1 trial " study type, pain, quality of life, functional effects and the patient satisfaction with assistive technology will be assessed for four weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patients aged 18 years old and above
- •Above knee or below knee amputation (irrespective of etiology and time from amputation)
- •Residual limb pain
- •Prosthetic with classic fitting
- •Fluctuations of residual limb requiring prosthetic adaptation (stump cotton sock, wedgning fitting ...)
- •Recipients or registered with a social security scheme
- •Informed consent form signed beforehand
排除标准
- •Patient with peripheral neuropathies contraindicating the use of Revofit system
- •Pregnant woman, nursing mother or parturiant
- •Patient in detention by judicial or administrative decision
- •Patient undergoing psychiatric compulsory care
- •Patient in a health or social institution for purposes other than research
- •Legally protected person
- •Patient unable to express their consent
结局指标
主要结局
Pain change assessment
时间窗: four weeks
Assess the impact of the Revofit™ system adjusted-fitting on residual limb pain compared to a classic fitting with a daily Visual Analog Scale evaluation \[VAS : 0 to 10 which constitues the worst outcome\].
次要结局
- Functional effects in twin task(Once a week during four weeks)
- Functional effects in simple task(Once a week during four weeks)
- Everyday comfort(four weeks)
- Patient satisfaction with assistive technology(Once a week during four weeks)