Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Highest pain reported: 1C70 vs everyday foot
研究概览
简要总结
The objective of this study is to characterize the extent of 1C70 meeting the amputees needs in comparison with their everyday and a comparator foot, in regards of daily activities, mobility and balance, as well as quality of life and pain.
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
- 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
- •Person is at least 18 years old.
- •Person is a unilateral transtibial amputee with stabilized residual limb.
- •Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL) .
- •Person has at least 6 months experience in walking with a prosthesis.
- •Person is using an energy storage and return (ESR) foot as their primary everyday foot
- •Person has a foot size between 22 and
- •Person weights with a prosthesis between 50 and 125 kg (foot size 26 - 30), or between 45 and 100 kg (foot size 22 - 25).
- •Person wears a prosthesis daily and ≥ 8 hours/day.
- •Person is able to walk at least 500 m without having to make a break.
- •Person is willing and able to independently provide informed consent.
- •Person is willing to comply with study procedures.
排除标准
- •Person is pregnant.
- •Person is using a hydraulic foot as their primary everyday foot.
- •Person is using a sport foot (e.g., Fillauer AllPro, Ottobock Challenger, Össur Flex-Foot Cheetah) as their primary everyday foot.
- •Person is using an ESR foot with an integrated vacuum pump (e.g., Ottobock 1C62 Triton Harmony).
- •Person has conditions that would prevent participation and pose increased risk (e.g., unstable cardiovascular conditions that preclude physical activity such as walking).
- •Person falls ≥ once a week due to the reasons that are not related to prosthesis (e.g., problems with vestibular system).
- •Person is not available for study visits during planned study duration.
- •Person is participating in another study or intends to participate in another study during this study´s duration.
- •Person cannot personally provide their consent.
结局指标
主要结局
Highest pain reported: 1C70 vs everyday foot
时间窗: Baseline measurement vs 2 months after fitting with 1C70
The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder \& neck area, phantom limb pain, while wearing the 1C70 foot compared to the everyday foot.
Extent of meeting amputees prosthetic foot needs: 1C70 vs everyday foot
时间窗: 2 months after fitting with the last study feet
The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for everyday foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs.
Extent of meeting amputees prosthetic foot needs: 1C70 vs comparator foot
时间窗: 2 months after fitting with the last study feet
The extent of meeting amputees prosthetic foot needs by 1C70 as measured by a single question with a 0 to 10 scale compared to the same score for comparator foot. Higher score correspond with higher extent of meeting amputees prosthetic foot needs.
Change in patient-perceived mobility (PLUS-M) compared to baseline
时间窗: Baseline measurement vs 2 months after fitting with 1C70
The change from baseline perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility.
Change in patient-perceived mobility (PLUS-M) compared to the comparator foot
时间窗: 2 months after fitting with each of the study feet
The change from baseline perception of mobility as measured by the Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item short form. The PLUS-M questionnaire provides a T-score that ranges from 21.8 to 71.4. Higher PLUS-M scores correspond with greater mobility.
Highest pain reported: 1C70 vs comparator foot
时间窗: 2 months after fitting with each of the study feet
The level of pain as a highest pain during preceding 7 days reported on a 0 ("No pain at all") to 10 ("the most intense pain imaginable") scale for the following origins: residual limb, sound limb, back, shoulder \& neck area, phantom limb pain, while wearing the 1C70 foot compared to the coparator foot.
次要结局
未报告次要终点