Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 75 Meter Self Selected Walking Test
研究概览
简要总结
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former C-Leg knee prosthesis.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral transfemoral or knee-disarticulation amputee
- •18 to 85 years of age
- •K3 (variable cadence and community) ambulators;
- •Current use of and experience with the C-Leg for at least 1 year
- •Ability to descend stairs and hills without caregiver and assistive devices
- •Be able to independently provide informed consent
- •Be willing to comply with study procedures.
排除标准
- •History of chronic skin breakdown on the residual limb
- •Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- •Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- •Unwillingness/inability to follow instructions
研究组 & 干预措施
Prosthetic knee 1 (Otto Bock C-Leg)
This arm included unilateral transfemoral amputees who were assessed while using their preferred knee at study start(C-Leg). The Otto Bock C-Leg is a microprocessor knee using 2 sensors (1 for kinetics and 1 for kinematics).
干预措施: Otto Bock C-Leg (Device)
Prosthetic knee 2 (Otto Bock Genium)
This arm included unilateral transfemoral amputees who were assessed while using the experimental/study knee, the Genium. The Otto Bock Genium is a microprocessor knee using multiple sensors that hypothetically increase mobility functions (e.g. walking backwards, intuitive stance)
干预措施: Otto Bock Genium (Device)
Non-amputee controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
结局指标
主要结局
75 Meter Self Selected Walking Test
时间窗: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Time to Complete a 75 meter walking distance.
Physical Functional Performance (Continuous Scale; 10-items)
时间窗: Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.
Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
次要结局
- Prosthesis Evaluation Questionnaire: Utility Score.(Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.)
- Balance and Stability(Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.)
研究者
Jason Highsmith
Principal Investigator
University of South Florida