ISRCTN14301627已完成未知
Clinical Investigation with 12-15 below-knee amputees to test the performance and safety of ProsFit Original Prosthetic Sockets, including blinded RCT comparison to the amputees' own existing prosthetic sockets
ProsFit Technologies UK Ltd.0 个研究点目标入组 15 人开始时间: 2015年3月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Amputee with trans-tibial amputation
- •2. Aged 18 years or above
- •3. Patient of SMRC
- •4. Activity Level Special Interest Group in Amputee Medicine (SIGAM) grade E or F (no significant limitations on walking distance, no use of walking aids, able to walk up shallow slopes and climb stairs, near normal gait or normal gait)
- •5. Willing and able to attend the planned research Visits, giving full attempt to adhere to the Investigation protocol in good faith (the patient may withdraw from the study at any point, without necessarily providing any reasons for doing so)
- •6. Willing and able to provide informed consent
- •7. Has a prosthesis that allows for its components to be disconnected from the traditional socket and then to be connected to the ProsFit Original prosthetic socket, and reconnected back, for the purposes of the research (connecting and reconnecting done by the prosthetist of the investigation team)
- •8. Uses an appropriate roll-on liner (this is worn between the residuum and the socket for cushioning and prosthesis suspension purposes) and is willing to use it during the Investigation
- •9. Willing to also use their own socket (non-ProsFit) as a comparator
- •10. Patient is expected to attend the clinic before and/or during the period in which the clinical investigation is taking place
- •11. No conflicts of interest related to participation or the results of the Investigation
排除标准
- •1. Pre-existing medical conditions that might put the patient at risk or lead to a failure to complete the study. This includes diabetes, ischaemic heart disease (angina), epilepsy, skin conditions that might lead to skin breakdown such as Ehlers-Danlos Syndrome, chronic obstructive airway disease.
- •2. Current acute medical conditions such as skin infections, stump sores / blisters or recent trauma to the stump
- •3. Under 18
- •4. Mental health disorders that may lead to difficulties with participation or understanding protocol
研究者
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