NCT06635655招募中不适用
Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
Proteor Group1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2025年2月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Goal Attainment Scale (GAS)
研究概览
简要总结
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.
详细描述
Multicentric, national, observational, prospective study, using AB type SCED.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •above-knee lower limb amputation
- •using an above-knee prosthesis with prosthetic knee and foot
- •eligible to use Synsys
- •able to design therapeutic objectives for the GAS
- •having a smartphone
排除标准
- •protected person
- •pregnant or breast-feeding lady
- •knee-to-ground height lower than 43cm
- •weighting more than 125kg
- •using their prosthesis for less than 2 weeks
- •not covered by health insurance
- •aged less than 18 or more than 84 years old
- •bilateral amputee or hip disarticulated
结局指标
主要结局
Goal Attainment Scale (GAS)
时间窗: From enrollment to the end of treatment at 8 weeks
Scale from -3 to +2. The higher the better. -3 being a deterioration, -2 being the baseline, 0 the objective, +2 the maximum
次要结局
- L-test and Dual-task L-test(Initial visit, at 4 weeks, and at 8 weeks)
- Two-minute walk test (2MWT) and 2MWT in divided attention(Initial visit, at 4 weeks, and at 8 weeks)
- Activity Balance Confidence Scale (ABC-scale)(at 4 weeks, and at 8 weeks)
- Prosthesis Evaluation Questionnaire (PEQ-A)(at 4 weeks, and at 8 weeks)
- Stumbles and falls(at 4 weeks, and at 8 weeks)
研究者
研究点 (1)
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