The Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis for People With Above-Knee Amputations, Bilateral Amputations, or Limited Mobility

University of Washington6 个研究点分布在 1 个国家目标入组 96 人开始时间: 2023年9月1日最近更新: 2024年5月23日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: University of Washington
入组人数: 96
试验地点: 6
主要终点: The Prosthetic Limb Users Survey of Mobility (PLUS-M™)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility.

The main study questions/goals are:

1a) To determine if frontal plane adaptation in a foot prosthesis impacts performance, comfort, activities of daily living, and community mobility in the study populations. To answer this question, we will compare a locked and unlocked version of the novel prosthesis.

1b) To determine how the unlocked investigational foot condition compares to the person's usual foot using the outcomes listed above.

To examine the participants' lived experience during community activities. The study will use performance tests, questionnaires, logbooks, and interviews to monitor person-centered outcomes and perceptions of personal functioning during the use of the investigational foot (locked and unlocked) compared to the person's usual foot.

详细描述

The study design is a randomized cross-over clinical trial design (B1 and B2 phases) comparing a carbon fiber foot that includes a functional, unlocked frontal plane adaptable linkage compared to the same foot with the linkage locked to prevent frontal plane motion. With the linkage locked, the foot is comparable to energy storage and return of a carbon fiber foot. The secondary aim for this clinical trial compares the unlocked foot to the participant's usual foot (A1 and A2 phases), representative of the usual standard of care.

The testing will be conducted following an A1-B1-B2-A2 design. The A conditions are focused on the participant's usual prosthetic foot. The B conditions are focused on locked and unlocked frontal plane adaptable linkages with the order randomized. Block randomization, stratified by study site, will be used to determine the order participants receive the locked and unlocked prosthetic. In our recent clinical trial, we developed a simple pin system to prevent the linkage from rotating.

A1 represents Visit 1, where demographic data are entered. As well, baseline questionnaires and performance data are collected. The participant will become familiar with the online data gathering systems. Then, the participant will be fitted with the adaptable foot by a licensed prosthetist. The linkage will be either locked or unlocked depending on the randomization. People with bilateral amputations will receive symmetrical prostheses.

During the ~2-week B1 phase, the participant will perform their normal community activities and contribute usage data, performance ratings, and qualitative data via the online logbook. There is the possibility that the decision may be made to re-fit the participant with a different stiffness of the study foot/feet that will be better suited. If this happens, the at-home use period of participation will be extended for another 2- to 4 weeks. At the end of the B1 phase, participants will complete standardized questionnaires and performance tests at Visit 2. Then, the linkage will be either locked or unlocked depending on the B1 randomization.

The ~2-week B2 phase will allow the participant to continue community activities and complete online logbooks. At the finish of the B2 phase, questionnaires and performance tests will be completed at Visit 3. A semi-structured interview will occur to compare the locked and unlocked versions.

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: 16 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participants will be 16-years or older, regardless of gender, race, or ethnicity.
•Potential participants should reside in the community or an independent living environment.
•The upper weight limit is 165.6 kg (365 lbs.).
•Prosthetic foot sizes 22 cm (approximate US Men's shoe size 5) up to 30 cm (13 US Men's).
•Ability to walk more than 400 m on level ground without an increase in pain.
•At least one year post-amputation and using a prosthesis
•People must have the ability to read, write, and comprehend English.

排除标准

•Participants must not have conditions such as skin wounds that preclude the use of a prosthesis.
•People will be excluded if they have fluctuating conditions that may significantly alter gait mechanics during the ~10-week study. Examples include Parkinson's disease, alcoholism, brain tumor, and hereditary cerebellar ataxias.
•Participants may use a walking aid but should not primarily rely on wheelchair mobility.
•People will be discontinued from the study if they become unable to use a prosthesis. Examples include major surgery and trauma. However, because of the potential for fluctuations in prosthesis use with this population, short-term issues will not disqualify people from continued participation when they resume prosthetic use.