Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Prosthetic Limb Users Survey of Mobility
研究概览
简要总结
High-quality, empirical evidence to guide prosthetic rehabilitation following amputation ensures that Service members, Veterans, and civilians who experience limb loss have the potential to receive the highest quality care, regain mobility, return to gainful employment, and reintegrate into their communities. However, evidence to inform prosthetic care during the crucial post-amputation period is extremely limited. The proposed research will address this gap in knowledge by evaluating functional and patient-centered health outcomes associated with use of two distinct prosthetic knee technologies in early rehabilitation following transfemoral amputation. This novel, comparative effectiveness research aligns with the Prosthetic Outcomes Research Award (PORA) focus area of understanding the management of patient rehabilitation strategies throughout the rehabilitation process following neuromuscular injury.
The long-term goals of this project are to optimize early rehabilitation processes and associated outcomes for Service members, Veterans, and civilians with lower limb amputation. The purpose of this study is to evaluate the potential for different prosthetic knee technologies to promote function, health, and quality of life following amputation. A pilot randomized controlled trial will be conducted to compare falls, step activity, balance confidence, mobility, health-related quality of life, and community integration of people with recent transfemoral amputation in two prosthetic knee conditions: a microprocessor knee (MPK) with control of stance phase and a non-microprocessor knee (NMPK) that is appropriate for people in early rehabilitation.
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
- Single (Outcomes Assessor)
盲法说明
Investigators who will conduct performance-based assessments will be blinded to the intervention.
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
- •18 years of age or older, Unilateral transfemoral amputation, Between 4-16 weeks post amputation, Deemed ready for prosthetic fitting by a physician, No current or prior transfemoral prosthetic use, Able to read, write and communicate in English, Weight 125kg (275lbs) or less
排除标准
- •Diagnosis of health condition (i.e. advanced cardiac disease, severe or end-stage pulmonary disease or severe dementia) that prevents safe prosthesis use or community ambulation with prosthesis, Weight greater than 125kg (275lbs)
研究组 & 干预措施
Microprocessor Knee
Ottobock Kenevo/Ottobock C-Leg
干预措施: Ottobock Kenevo/C-Leg (Device)
Nonmicroprocessor knee
Ottobock 3R60 for K3 participants, Ottobock 3R62 for K2 participants.
干预措施: Ottobock 3R60/3R62 (Device)
结局指标
主要结局
Prosthetic Limb Users Survey of Mobility
时间窗: Monthly for 3 months
Self-reported prosthetic mobility
次要结局
- Amputee Mobility Predictor (AMPPro) Assessment Tool(Monthly for 3 months)
- Six-minute walk test(Monthly for 3 months)
- Fall frequency(Monthly for 3 months)
- Daily step count(Average daily step count by month for 3 months)
- Timed up and go(Monthly for 3 months)
- Gait quality(Monthly for 3 months)
- Activities-Specific Balance Confidence Scale (ABC)(Baseline and monthly for 3 months)
- Patient Reported Outcomes Measurement Information System 29-item profile (PROMIS-29) version 1.0(Baseline and monthly for 3 months)
- Reintegration to Normal Living Index (RNLI)(Baseline and monthly for 3 months)
研究者
Sara Morgan
Acting Assistant Professor, Department of Rehabilitation Medicine
University of Washington
