Caesar Foot Take-Home Validation Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Prosthetic Limb Users Survey of Mobility (PLUS-M)
研究概览
简要总结
The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment. Participants will take the device home and use it throughout their daily life for two months. A one-month baseline period, using their usual foot, will be completed both before and after the two-month period with the Caesar foot condition. Self-report surveys and performance-based measures will be collected in the clinic at the end of each condition. The intent of this study is to determine the Caesar foot's feasibility in a real-world environment. Data will be collected to understand impact to the user's daily life and physical activity through outcomes and participant feedback. The feedback obtained during this study will be essential to informing the design intended for commercialization.
详细描述
In this study, the investigators will administer a suite of performance-based and self-report measures to assess demonstrated and perceived differences between the foot conditions. The primary measure for this study is the Prosthetic Limb Users Survey of Mobility (PLUS-M). The investigators hypothesize that the participants will have greater mobility as reported by the PLUS-M in the Caesar foot as compared to their usual walking foot.
There are many aspects of mobility and activity that may not be captured by a single assessment. Therefore, the investigators will examine additional exploratory self-report measures after each condition during this pilot study, such as the PROMIS-Fatigue, PROMIS- Ability to Participate in Social Roles and Activities (PROMIS-APSRA), PLUS-Falls (PLUS-F), Trinity Amputation and Prosthesis Experience Scale - Revised (TAPES-R), EQ-5D, and custom surveys to further understand the participant's experiences and preferences with the Caesar foot. Surveys will be distributed on a HIPAA compliant platform, such as MS Forms, which can be completed on the clinic's laptop/tablet. Paper formats of the surveys may be distributed if issues arise with the online platform (e.g., internet outage).
The investigators will also conduct and collect performance-based measures from each participant, such as the 10-Meter Walk Test (10MWT), self-selected comfortable and fast gait speeds, comfortable running speed, and timed ¼ mile run. These measures are exploratory as well. The investigators will assess running effort objectively with the maximum heart rate (HRmax) during the ¼ mile run and subjectively using the Borg Rating of Perceived Exertion (RPE). During each 1-month take-home period, the investigators will measure participants' daily step count and track any falls that may occur.
In addition to wearing the activity monitor during the take-home periods, they will also be asked to participate in periodic calls with study team members to check in and report on any falls, issues they may be experiencing, and/or ask questions they may have about the study. These periodic calls will continue throughout the duration of the study.
As a pilot study, the goal of these measures is to better understand the impact of the Caesar foot on different aspects of a user's life and incorporate feedback into future designs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Have transtibial limb absence of one or both limbs
- •Express interest in running, but do not currently have a running blade (as determined by self-report)
- •Are at least 18 years of age
- •Are at least six months post amputation
- •Are classified as K3 or K4 ambulator status as determined by a certified prosthetist
- •Have an AMP score of at least 37
- •Are capable of running safely as determined by a certified prosthetist's clinical judgement
- •Have a well-fitting socket as determined by a certified prosthetist
- •Have adequate clearance between distal end of the residual limb and ground for the Caesar foot
- •Meets the foot size and weight class of one of the available Caesar prototypes
排除标准
- •Present or sustained injuries to residual limb or contralateral leg affecting functional ability
- •Non-English speaking participants will be excluded from this study due to limited access to interpreter services. These services would be needed for several visits, including training to learn how to use the device safely, along with requested verbal feedback from the participant to evaluate the design and usability of the system.
- •Using a prosthetic foot that an individual is unfamiliar with for higher activity tasks may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.
- •Individuals can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).
结局指标
主要结局
Prosthetic Limb Users Survey of Mobility (PLUS-M)
时间窗: 1 month
The version of the PLUS-M being administered consists of 22 questions. Each question asks about their ability to ambulate in certain instances and at certain speeds, and is scored on a scale of 1 (unable to do) to 5 (without any difficulty). A higher score indicates a better outcome. This survey will be given at the end of each study condition. Since the first month of the Caesar condition will be for training and acclimation, the PLUS-M will be given after the second month that the participant is in the experimental condition.
次要结局
未报告次要终点