NCT04791163已完成不适用
AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study
Proteor Group18 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 18
- 主要终点
- Comfort evaluation
研究概览
简要总结
Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.
详细描述
Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.
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
- Single (Outcomes Assessor)
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
- •can give informed consent
- •aged 18 or more
- •above-knee amputee, wearing a definitive ischial containment socket
- •stump longer than 16cm
- •wearing a liner, whatever the suspension system
- •able to walk (d4600, d4601, d4602, d4608 accordinf to IFC)
- •unilaterla or bilateral amputee
- •able to done the socket standing
- •whatever the etiology
排除标准
- •protected person
- •pregnant woman or nursing mother
- •subject having comorbidities heavily impacting feeling or socket donning
- •allergic to silicon
- •suffering from big volume variations in a same day
- •infecté stump (may lead to lymphatic problems)
结局指标
主要结局
Comfort evaluation
时间窗: 1 minute
Socket Comfort Score (SCS)
次要结局
- Comfort evaluation in various situations(1 minute)
- Locomotor capability(5 minutes)
研究者
研究点 (18)
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