Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Amputee Mobility Predictor with Prosthesis (AMPPRO)
研究概览
简要总结
The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.
详细描述
Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited.
In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transtibial amputation
- •Age 18-99 years old
- •Body weight below 275 lbs
- •Non-pregnant
- •English speaking
- •Current user of prosthesis for at least one year
- •Wear time 8 hrs/day or more
- •MFCL ≥ K-3
- •Well-fitting and functioning prosthesis
- •No use of ambulatory aide
- •Able to tolerate testing protocol
- •Able to walk on slopes
- •Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments
排除标准
- •Amputation level other than unilateral transtibial
- •Age <18 or >99 years old
- •Body weight above 275 lbs
- •Non-English speaking
- •Not current user of prosthesis
- •Less than one year use of prosthesis
- •Wear time less than 8 hr/day
- •MFCL <K3
- •Poor fitting and functioning prosthesis
- •Indicating that the socket fit is painful, or unacceptable
- •Use of ambulatory aide
- •Unable to tolerate testing protocol
- •Unable to walk on slopes
- •Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study
- •Any neurologic impairments known to cause gait and/or balance dysfunction
研究组 & 干预措施
Configuration A (Kinnex)
干预措施: Kinnex (Device)
Configuration B (Pacifica LP)
干预措施: Pacifica LP (Device)
结局指标
主要结局
Amputee Mobility Predictor with Prosthesis (AMPPRO)
时间窗: Collection at baseline
The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability
L-Functional Test (L-Test) Baseline
时间窗: Collection at baseline
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
6 minute Timed Walk Test (6m TWT) Baseline
时间窗: Collection at baseline
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Hill Assessment Index (HAI) Baseline
时间窗: Collection at baseline
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
5 times Sit-to-Stand (5 times STS) Baseline
时间窗: Collection at baseline
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
Physiological Cost Index (PCI) Baseline
时间窗: Collection at baseline
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
5 times Sit-to-Stand (5 times STS) after 4 weeks
时间窗: Collection after 4 weeks
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
6 minute Timed Walk Test (6m TWT) after 4 weeks
时间窗: Collection after 4 weeks
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline
时间窗: Collection at baseline
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks
时间窗: Collection after 4 weeks
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
Hill Assessment Index (HAI) after 4 weeks
时间窗: Collection after 4 weeks
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
L-Functional Test (L-Test) after 4 weeks
时间窗: Collection after 4 weeks
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
Physiological Cost Index (PCI) after 4 weeks
时间窗: Collection after 4 weeks
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
次要结局
- Activities-Specific Balance Confidence Scale (ABC)(Collection after 4 weeks)
- Orthotic Prosthetic User Survey (OPUS)(Collection after 4 weeks)
- Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)(Collection after 4 weeks)
- Prosthesis Limb User Survey of Mobility (PLUS-M)(Collection after 4 weeks)
- Socket Comfort Score (SCS)(Collection at baseline and after 4 weeks)
研究者
Brian Kaluf BSE, CP
Clinical Outcome and Research Director
Ability Prosthetics and Orthotics, Inc.