NCT06017024已完成不适用
Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial
Proteor Group5 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年6月7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
- 18
- 试验地点
- 5
- 主要终点
- Personal goal achievement
研究概览
简要总结
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and give informed consent
- •Man or woman, more than 18 y.o
- •Lower limb amputee KD or AKA, unilateral or bilateral
- •K3/K4 activity level
- •Already fitted with FR-reimbursed MPK
- •Being comfortable in their socket (SCS>=5)
排除标准
- •Protected person
- •Pregnant or breast feeding lady
- •Person having pathologies affecting their sensitivity
- •Using walking aids
- •Weighting more than 136kg
- •Insufficient hip joint or pelvic voluntary muscle control
- •Insufficient cognitive ability to charge the knee and care for the device
结局指标
主要结局
Personal goal achievement
时间窗: test sessions 1 and 2 (20 minutes)
Patient-specific Functional Scale - PSFS - \[0-10\], the higher the better
次要结局
- Functional walking test - fast walking speed(test sessions 1 and 2 (1 minute))
- Functional test - ability to walk downstairs(test sessions 1 and 2 (3 minutes))
- Questionnaire to assess satisfaction(test sessions 1 and 2 (5 minutes))
- Functional test - ability to walk downhill(test sessions 1 and 2 (3 minutes))
- Prosthesis Evaluation Questionnaire(test sessions 1 and 2 (29 minutes))
- Functional walking test - mobility capacity(test sessions 1 and 2 (8 minutes))
- Questionnaire to assess comfort in the socket(test sessions 1 and 2 (1 minute))
- Questionnaires to assess quality of life(test sessions 1 and 2 (5 minutes))
研究者
研究点 (5)
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