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临床试验/NCT03433300
NCT03433300已完成不适用

Do Microprocessor Knees Improve Outcomes in Early Prosthetic Rehabilitation Compared to Nonmicroprocessor Knees?

University of Washington1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年4月13日最近更新:
适应症
干预措施

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

Experimental

Ottobock Kenevo/Ottobock C-Leg

干预措施: Ottobock Kenevo/C-Leg (Device)

Nonmicroprocessor knee

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Morgan

Acting Assistant Professor, Department of Rehabilitation Medicine

University of Washington

研究点 (1)

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