Clinical Investigation (Beta) of Power Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Mean Difference in Borg Category Rating Scale Before and After 6MWT at 2 Weeks
研究概览
简要总结
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
The primary objective was to evaluate the efficacy of the investigational device in reducing exertion during walking compared to passive MPKs. Additionally to evaluate the efficacy of the investigational device in the short and long term compared to passive MPKs and previous versions of the Power Knee, during daily living activities i.e. walking on level ground, in stairs and inclines, rising from and sitting down to a chair as well as performance of gait functions and ease of set up for average to highly active transfemoral/knee disarticulation amputees and Certified Prosthetists/Orthotists (CPOs).
详细描述
This is a prospective two group cross-over study, within subject comparison. 3 study visits are planned for amputee subjects, with approximately 2-3 weeks between visits, and an optional fourth visit 8-12 weeks after the third visit. During the first visit subjects will be check for inclusion/exclusion, consented and randomly assigned into two groups and Group 1 (transitioning to the investigational device) will perform functional tests and answer questionnaires on the performance of their current prosthesis to provide baseline information. The Group 1 subjects will be fitted and trained on the investigational device and a recommended prosthetic foot which they will use as their prescribed prosthesis for 2-3 weeks until the second visit, the other half will stay on their prescribed prosthesis until the second visit.
During the second visit the subjects of Group 1 will perform the same functional tests as in the first visit on the investigational device and answer questionnaires on the performance of the investigational device, and then return to their prescribed prosthesis. The Group 2 will perform the same tests/questionnaires on their prescribed prosthesis and then be fitted and trained on the investigational device and use it as their usual prosthesis for 2-3 weeks.
During the third visit all subject will repeat the tests and questionnaires on the prosthesis they are fitted with (Group1 on the prescribed and Group 2 on the investigational device). Subjects will have the option to use the investigational device for an additional 8-12 weeks, those who choose that will be fitted with the investigational device or will stay on it, depending in which they are in at this point. They will be booked for the fourth visit; they will be contacted via telephone 4-5 weeks later and asked to provide feedback on their experience with the device so far. Those that choose not to keep using the investigational device will be returned to their prescribed prosthesis.
During the fourth visit subjects will answer the same questionnaires and perform the same functional tests as the other visits. Data will be collected from the knee on activity. They will then be fitted back to their prescribed prosthesis.
End of study. CPO (Certified Prosthetist Orthotist) subjects will answer a questionnaire on the ease of setup of the investigational device and provide feedback on the ease of setup of gait functions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50Kg< body weight < 116Kg
- •K3-K4 amputees with unilateral transfemoral amputation or Knee disarticulation
- •Allows for 37mm knee center height to dome of pyramid alignment
- •Currently using a MPK or Power Knee
- •Older than 18 years old
- •No socket issues/changes in the last 6 weeks and no socket changes expected during the duration of the study period.
- •Comfortable and stable socket fit
- •Willing and able to participate in the study and follow the protocol
排除标准
- •50Kg> body weight > 116Kg
- •Bilateral amputees
- •Users with socket problems
- •Users with co-morbidities in the contra-lateral limb, which affect their functional mobility
- •Younger than 18 years old
- •Users with stump pain
- •Users with cognitive impairment
- •Users not involved in other clinical tests and/or receiving treatment that the testing might affect.
结局指标
主要结局
Mean Difference in Borg Category Rating Scale Before and After 6MWT at 2 Weeks
时间窗: At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16)
Mean difference in perceived exertion on the Borg rating scale of perceived exertion before and after 6 minute walk test (6MWT) (see outcome 2) with investigational device (Power Knee) compared to comparator (prescribed device). Subjects are asked how exerted they feel on a scale of 0-10 (0 indicating no exertion and 10 indicating the most exertion) at rest before they carry out the 6MWT, and after carrying out the 6MWT, the difference is recorded. The Borg Category Rating 10 scale (CR10) is a validated measure of perceived exertion.
Average Distance Walked in 6 Minute Walk Test
时间窗: At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16)
Average distance walked in 6MWT with investigational device (Power Knee) compared to comparator (prescribed device) User walk for 6 minutes in their self selected walking speed on a 30 meter track. Shorter time indicates better mobility performance.
次要结局
- Total Score of Prosthesis Mobility Questionnaire (PMQ) Questions 9 and 10(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Average Score of Modified Prosthesis Evaluation Questionnaire (PEQ) Question 14F(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Average Score of Modified Prosthesis Evaluation Questionnaire (PEQ) Question 13D(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Satisfaction With Walking Speed(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Prosthetic Limb Users Survey of Mobility (PLUS-M) T-score(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Average Score of Modified Prosthesis Evaluation Questionnaire (PEQ) Question 13A(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Average Score of Prosthesis Evaluation Questionnaire (PEQ) Question 1D(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Average Score Regarding the Ease of Setup(Immediately after the intervention (fitting of the investigational device))
- Proportion of Participants With Average Score Over 5 on Questions 3K and 3L of the Prosthesis Evaluation Questionnaire (PEQ) With the Investigational Device(After 2 weeks of either using the Power Knee or their own prescribed knee)
- Total Score of Prosthesis Mobility Questionnaire (PMQ) Questions 1 and 3-6:(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Time Required to Complete the L-test(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Average Prosthetic Mobility Questionnaire (PMQ) Total Score(At baseline, after 2 weeks of either using the Power knee or their own prescription prosthesis, and at the fourth follow-up (at approximately weeks 22-16))
- Occurrence of Side Effects That Could be Directly Related to Using the Power Knee(After 2 weeks of using the Power Knee)