Investigation on a New Power Knee Firmware Update on Gait and Daily Life Activities, a Randomized Controlled Double-blinded Cross-over Investigation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Sit to Stand Activity
研究概览
简要总结
The goal of this interventional study is to investigate a new firmware in development for Power Knee on gait and daily life activities in unilateral transfemoral amputees. The main question it aims to answer is:
What are the effects of a new firmware on sit-to-stand, level walking and stair ascent ?
Researchers will compare both a new and the current marketed firmware to see if there is any changes in performance.
Participants will be asked to perform some activities of daily living and some functional tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •50 kg < body weight < 116 kg
- •lower limb loss, amputation or deficiency
- •cognitive ability to understand all instructions and questionnaires in the study
- •Unilateral transfemoral amputees that are regular Power Knee users for at least 4 weeks
- •age ≥ 18 years
- •Moderate to high active subjects
- •Willing and able to participate in the study and follow the protocol
- •Comfortable and stable socket fit
- •No socket issues/changes in the last 6 weeks
排除标准
- •Users with pain
- •Bilateral amputees
- •Users using passive microprocessor controlled knees
- •Users with cognitive impairment
- •Users with co-morbidities in the contra lateral limb, which affect their functional mobility
- •Hip disarticulation amputees
- •Users with osseointegrated prosthesis
- •Pregnant users
研究组 & 干预措施
Group A
Group A will start with the current marketed firmware.
干预措施: Power Knee Firmware Update (Device)
Group A
Group A will start with the current marketed firmware.
干预措施: Power Knee Current Marketed Firmware (Device)
Group B
Group B will start with the firmware in development.
干预措施: Power Knee Firmware Update (Device)
Group B
Group B will start with the firmware in development.
干预措施: Power Knee Current Marketed Firmware (Device)
结局指标
主要结局
Sit to Stand Activity
时间窗: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing sit to stand activity
Stand to Sit Activity
时间窗: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing stand to sit activity
Level Ground Walking
时间窗: after acclimatization at day 1 during the single study event
Each participant rated whether the new investigational firmware was worse, similar, or better compared to the current marketed firmware when performing level ground walking.
次要结局
未报告次要终点