Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Magnitude of loading pattern
研究概览
简要总结
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of daily living. The assessment of the inner prosthetic loading will rely on the analyses of common activities of daily living (e.g., walking in straight line and around circles, ascending and descending stairs and slopes, cycling, etc.) performed in experimental and/or clinical and/or open environments.
The biomechanical analyses of the load will address the following research questions:
A. What is the actual magnitude of the forces and moments applied on transfemoral osseointegrated implant by Rheo Knee and Power Knee during activities of daily living? living? B. What are the determinants of the loading profile in relation to the demographic and anthropometric characteristics, the type and level of activities as well as type, fitting and alignment of Rheo Knee and Power Knee? C. How the loading profiles applied by Rheo Knee and Power Knee compared to usual MPKs and Non-MPK considered below standard of care?
Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time). These biomechanical analyses will rely on already published protocols (e.g., study design, instrumentation setup, extraction of loading profile). Protocols to record load data have been well described by PI-Frossard in over 20 peer-review publications in top-ranked journals. The protocol used in this study has been acknowledged, validated and are commonly used within the fields of biomechanics and prosthetics.
The outcome of this study will increase the basic understanding about the effects of loading on the interaction between body and prosthesis (e.g., osseointegration between residual bone and implant). The study will also increase applied knowledge required to establish stronger evidence-based rehabilitation programs, fitting of prosthetic limbs and design of bionics prosthetic components.
It is anticipated that, both basic and applied knowledge gain in this study will, all together, contribute to increase the health-related quality of life of individuals fitted with socket and bone-anchored prostheses.
详细描述
Design Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time).
Arms
The whole observational study will involve a total of 30 participants (20 prospective and 10 retrospective data sets) considered in the following fours arms:
- Arm 1 will be designed as observational study providing the efficacy and safety of the load applied on osseointegrated fixation by transfemoral BAP fitted with the Power Knee for the whole cohort of 20 participants.
- Arm 2 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and usual microprocessor controlled knees (MPKs) (e.g., C-Leg, Genium) for the whole cohort of 20 participants.
- Arm 3 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and Rheo Knee XC for a subgroup of 5 participants.
- Arm 4 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee for the whole cohort of 20 participants and non-MPKs for another cohort of 10 participants.
Only arms 1 to 3 will involve new recording of the loading profile as part of the prospective cross-sectional cohort study for a total of 20 participants. Arms 4 will constitute the retrospective part of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be willing to participate to this project of research,
- •be able to be fitted with common bionic prosthetic components (e.g., Knee, feet),
- •be willing to comply with protocol,
- •have a lower limb amputation more than 12 months prior testing,
- •have a clearance of at least 6 cm between residuum and prosthetic joint,
- •have completed rehabilitation program,
- •be free of injuries on the day of the recording session,
- •weigh less than 121 kg,
- •be able to walk 200 meters independently,
- •be between 18-80 years of age.
排除标准
- •not be able to give informed consent,
- •have bilateral amputation,
- •have self-reported pain levels greater than 4 out of 10 at study outset,
- •have experienced a fall within the last 8 weeks before assessment,
- •have mental illness or intellectual impairment,
- •have injuries involving contralateral (intact) limb,
- •have major uncorrected visual deficit,
- •have history of epilepsy or recurrent dizziness,
- •present signs of infection 2 weeks prior testing session.
结局指标
主要结局
Magnitude of loading pattern
时间窗: 24 months
Loading extrema correspond to onset and magnitude of a point of inflection of the loading pattern of three components of force and moment occurring consistently over successive steps, measured by the load cell as described above.
Maximum moments in gait cycle
时间窗: 24 months
Loading boundaries corresponds to the minimum, maximum and absolute maximum of the three components of forces and moments across gait cycles in relevant segment regardless of the onset, respectively, measured by the load cell as described above.
Cadence
时间窗: 24 months
Strides per minute (stride/min) corresponding to the duration between two consecutive heel contacts of the prosthetic limb measured by the load cell as described above.
次要结局
- Prosthesis efficacy(24 months)
- The variability of datasets(24 months)
- Factor of safety(24 months)