NCT06627361已完成不适用
Prospective, Multicentric, Comparative, Randomized, Cross-over Study Evaluating the Mobility of Transtibial Amputee Patients Using the PRO-FLEX PIVOT® Foot Versus a Class III Energy Storing and Returning (ESAR) Prosthetic Foot
Össur Iceland ehf2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of mobility of the patient
研究概览
简要总结
The PRO-FLEX PIVOT® is ESAR prosthetic foot with an innovative technology built around three pillars:
- The PIVOT technology: three axes of rotation (upper support, main pivot and lower support) at the ankle, which allow both a movement with more amplitude and closer to the physiological movement of the ankle, and an increase in the power of the ankle, especially in the terminal support phase.
- The technology of the three carbon blades (plantar, upper and median), including a wider plantar blade, split in the middle of the foot with a separate toe to provide efficiency over the entire length to the big toe, bringing more power to the impulse and more control, but also increased stability until the terminal support phase.
- An anatomical foot cosmetic, to adapt and optimize the function of the blade: of light manufacture, with an adherent sole for more stability barefoot, it guarantees physiological plantar pressure during the unwinding of the foot.
The aim of this study is to demonstrate that compared to a class III ESAR foot, the PRO-FLEX PIVOT® foot improves patient mobility with a validated score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Adult patient (over 18 years of age)
- •Unilateral tibial amputee and fitted for at least 6 months with a class III ESAR foot.
- •Regularly using (more than 8 hours/day) a class III ESAR foot
- •Functional class (CNEDiMTS indication)1
- •Insured person.
- •Able to answer questionnaires.
- •Providing informed and written consent to participate in the study.
- •Having a normalized PLUS-M/FC 12 score less than 50 for vascular amputee and 55 for traumatic amputee and other causes of amputation.
- •Experiencing no discomfort related to the socket indicated by a score ≥ 6 on the numerical scale from 0 to 10 (Socket Comfort Score)
排除标准
- •Bilateral lower limb amputation
- •Femoral amputation
- •Wearing a temporary prosthesis
- •Change of socket or suspension system planned during the study.
- •Change of any functional component as torsion or choc adapter
- •Significant change in the patient's routine activities expected during the study.
- •Progressive associated pathology that may prevent patient follow-up.
- •Associated pathology that may limit the patient's mobility (e.g. disarticulation of the knee, knee pain... )
- •No osteointegration patients
- •Lack of consent
- •Adult subject to enhanced protection, deprived of liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
- •Person not affiliated with or a beneficiary of a health insurance plan.
- •Patient unable to understand the study instructions
研究组 & 干预措施
PRO-FLEX PIVOT
Experimental
The patient will be fitted with PRO-FLEX PIVOT® foot for a duration of 28 days, with a variance of ±2 days
干预措施: PRO-FLEX PIVOT Foot evaluation (Device)
Class III ESAR foot
Active Comparator
The patient will be fitted with his usual class III ESAR foot for a duration of 28 days, with a variance of ±2 days
干预措施: Class III ESAR Foot evaluation (Device)
结局指标
主要结局
Change of mobility of the patient
时间窗: 28 days
Assess the foot impact on the patient mobility assessed with Prosthetic Limb Users Survey of Mobility (PLUS-M™) questionnaire. The score ranges from 21.8 (indicated lower mobility) to 71.4 (indicating higher mobility)
次要结局
- Variations in comfort experienced during the wearing of the foot(28 days)
- Change in quality of life(28 days)
- Change in satisfaction of the patient(28 days)
- Occurence of falls(28 days)
- Number of patients with technical incidents(28 days)
研究者
研究点 (2)
Loading locations...
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