Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 180
- 主要终点
- Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
研究概览
简要总结
Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.
详细描述
Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transfemoral or knee disarticulation amputation
- •Received prosthesis between 4 - 24 months prior
- •Currently uses prosthesis
- •K2 ambulator status
- •Able to speak English or Spanish language
- •Age ≥ 65 years at Baseline Assessment (one month after enrollment)
- •Minimum Socket Comfort Score (SCS) of 6/10
排除标准
- •Upper limb involvement
- •Individuals ≥ 275 lbs
- •Unable to provide informed consent
- •History of acute or chronic residual limb breakdown
- •History of 2 or more socket adjustments or replacements in the past 6 months
- •Amputation of the contralateral limb
- •Active malignancy
- •Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel
- •Patient unable or unwilling to follow study procedures
- •Pregnant women, institutionalized persons, and children
结局指标
主要结局
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)
时间窗: 5 years
This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)(3 years)
- Patient-Reported Outcomes Measurement Information System (PROMIS) - 29(3 years)
- Average daily step counts(12 months)
- 12-month fall count from bi-weekly fall journal(12 months)
- Fear of Falling Avoidance Behavior Questionnaire (FFABQ)(3 years)
- 10-meter Walk Test (10mWT)(3 years)
- Timed Up and Go (TUG)(3 years)