Assessment of a Microprocessor Ankle for Low Mobility Individuals
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Amputation
- 发起方
- Synchro Motion LLC
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Minimum Foot Clearance
- 状态
- 已完成
- 最后更新
- 10个月前
概览
简要总结
This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle. The DSR ankle is a new design to support a person while they walk on both even and uneven ground, as well as with bending the ankle for safe foot clearance while a person takes a step. In particular, in this study we are interested in seeing how this type of new device may benefit people who are rated as a K2-level ambulator.
详细描述
Synchro Motion, LLC developed a novel MPC ankle. Because of its unique actuation scheme, the prosthesis can behave as: (1) a lockable conformal damper, (2) a variable set-point spring, and (3) an actively repositionable joint. The investigators therefore refer to the device as the damping, stiffness, and repositioning (DSR) ankle. The DSR ankle is small, lightweight, quiet, and runs for multiple days on a single charge. No other commercially available prosthesis combines this set of features. It will be shown in preliminary work that the features of the DSR ankle can increase toe clearance in swing, reduce the time-to-foot-flat after heel strike, and improve weight bearing symmetry when standing on slopes for K3 Individuals with Lower Limb Amputation (ILLAs). These biomechanical functions have all been linked to improved safety and stability, which leads the investigators to hypothesize that the DSR ankle may provide benefits to K2 ILLAs as well. The main purpose of this research is to determine the ways in which the DSR ankle may be adapted to provide benefits specifically to ILLAs who use their prosthesis at the K2 level. For purposes of the Phase I work, the development and assessment will be performed exclusively with K2 ILLAs in order to provide an opportunity to implement any necessary refinements to the DSR ankle to ensure optimal K2 performance. The remainder of the research is to quantify the effectiveness of the DSR ankle as compared to a predicate non-MPC ankle in improving performance for K2 ILLAs.
研究者
入排标准
入选标准
- •Adults aged 18-89 years
- •Patients who have a unilateral transtibial amputation who are able to use a prosthesis and who currently use a passive, non-MPC prosthesis
- •K2 level ambulators
排除标准
- •Pregnant women
- •Children (\<18 years old)
- •Prisoners or institutionalized individuals
- •Individuals who have the inability to give informed consent
- •Participants unable to walk for 2 minutes without an assistive device
- •Participants with complicating health conditions that interfere with the study
- •Inability to read and understand the English language. As this is a pilot study with a small sample size, it is prohibitive to translate Study documents to other languages as recruitment will be from a sample of convenience.
结局指标
主要结局
Minimum Foot Clearance
时间窗: after up to 3 weeks of training
Minimum foot clearance is the shortest distance between the foot and the ground during swing, and it occurs approximately halfway through the swing phase of gait.
Time to Foot Flat
时间窗: after up to 3 weeks of training
Time to foot flat is the duration of time between initial contact at heel strike and the full contact of the sole of the foot on the ground in stance.
次要结局
- Orthotics Prosthetics User Survey (OPUS) Device Satisfaction(after up to 3 weeks of training)
- 10 Meter Walk Test (10 MWT)(after up to 3 weeks of training)
- Six Minute Walk Test (6 MWT)(after up to 3 weeks of training)
- Timed Up and Go (TUG)(after up to 3 weeks of training)