Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees by K4-level Transfemoral Amputees
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Daily Step Count
研究概览
简要总结
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a larger spectrum of patient populations (K2-K4), as well as testing additional Power Knees currently in development that are expected to become commercialized in the near future. The investigators intend to use this Level 2 trial data to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with MPKs is needed to allow for improved clinical decision making and clinical outcomes.
详细描述
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators envision that this Level 1 submission will transition into a larger follow-on Level 2 trial that will explore a larger spectrum of patient populations (K2-K4), as well as testing additional Power Knees currently in development that are expected to become commercialized in the near future. The investigators intend to use this Level 2 trial data to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with MPKs is needed to allow for improved clinical decision making and clinical outcomes.
This study will focus on investigating the tradeoffs between the commercially available Ossur Power Knee and traditional MPKs to identify the prosthetic knee that is best suited for K4 users during different tasks. The investigators will assess measured, observed, and self-reported outcomes achieved through real-world use of the prosthetic knees.
The results of this study will (1) provide initial data to inform the evidence-based prescription and use of powered knee technologies for K4-level individuals with sound scientific data, (2) provide pilot data for a larger clinical trial to further inform the evidence-based prescription of powered knee technologies to other K-levels to maximize patient benefit while optimizing device cost and thereby influencing clinical practice and informing policy decisions, and (3) provide data that can be disseminated to other researchers to inform the design of future powered prosthetic knees by understanding the needs of users and identifying the features and functions that are most valuable to this patient population as well as the capabilities and limitations of current devices.
The primary outcome measures for each aim are outlined as follows:
- [Mobility Primary Outcome]: daily number of steps taken
- [Safety Primary Outcome]: Activities-Specific Balance Scale
- [Wellbeing Primary Outcome]: PEQ-Well-Being (PEQ-WB)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- •Are at least 18 years old
- •Unilateral transfemoral prosthesis user (limb absence between the knee and hip)
- •Current user of a microprocessor-controlled knee (MPK)
- •Have adequate clearance between distal end and ground for necessary knee and foot components
- •Medicare Functional Classification Level (K-Level): 4
- •Socket-Comfort Score: 6 or above to ensure adequate socket fit
- •PLUS-M T-score of 55 or above
- •Six months or more experience on a prosthesis
- •Body weight between 50kg and 116kg (110lbs - 256lbs)
排除标准
- •Present injuries to residual limb or contralateral leg affecting functional ability
- •Socket issues/changes in the last 6 weeks
- •Users with bone-anchored implants
- •Subjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.). Subjects in this study will not be discriminated by sex/gender or race/ethnicity.
- •Using a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
结局指标
主要结局
Daily Step Count
时间窗: 1 Month
Prior to each condition, each subject will be fit and aligned on the designated knee by a trained certified prosthetist. An activity monitor (such as the GeneActiv™) will be worn by the subject for each intervention period during the final month of the condition. Similar to prior studies, the investigators will use the activity monitor to track the number of steps the subjects take in each condition per day. The number of steps per day are averaged over the final month in each condition. A higher value indicates a better outcome.
Activities-Specific Balance Confidence Scale (ABC) - Measuring Change From Baseline
时间窗: At the end of each 3 month condition
Activities-specific balance confidence (ABC) scale is a structured questionnaire that measures an individual's confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions gauging the individual's confidence while doing activities, from 0 (no confidence) to 4 (complete confidence). Therefore, the total score ranges from 0 to 64, with a higher value indicating a better outcome. This survey will be given at the end of each study condition (2 conditions, 3 months per condition). This survey will be administered as a part of the master questionnaire. Analysis is reported in % of balance confidence, which is found by taking their average of all questions (sum up all questions and divide by total number of questions) and dividing that average by 4.
PEQ-Well Being (PEQ-WB) - Measuring Change From Baseline
时间窗: At the end of each 3 month condition
The version of the PEQ which will be administered consists of 2 questions in 1 category (well being). For purposes of easier administration, the investigators have adopted the modified 10-point ordinal scale version of the PEQ-WB (scale 1-10, where 1 is the worst and 10 is the best relative to the questions being asked). This survey will be given at the end of each study condition (2 conditions, 3 months per condition). This survey will be administered as a part of the master questionnaire. The reported result is the average of the 2 questions in the PEQ-WB. The range of this reported result is 1-10, where a higher value indicates a better outcome.
次要结局
未报告次要终点
研究者
Jennifer Johansson
Principal Investigator
Liberating Technologies, Inc.