Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bone-Implant Stress/Strain Impulse during Decline Walking (internal)
研究概览
简要总结
A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.
详细描述
This will be a clinical trial with two groups (individuals with a unilateral transtibial amputation using either an osseointegrated bone-anchored limb or socket prosthesis that will implement a cross-over design. The objective of this clinical trial is to determine how changes in prosthetic foot stiffness influence clinical and biomechanical outcomes in patients with transtibial osseointegrated bone-anchored limbs compared to patients with transtibial amputation using a standard socket-suspended prosthesis. Although proper loading between the bone and implant is pivotal to promote and maintain osseointegration, which is required for physiological loading and thus positive outcomes, evidence surrounding the role of how prosthetic componentry influences force transmission and functional outcomes in this population currently does not exist. The findings of this clinical trial will address a critical knowledge gap pertaining to the role of componentry on multi-loading domain outcomes. Outcomes will be assessed in each participant in the same three conditions: one with their clinical prescribed prosthetic foot, one with a soft prosthetic foot (-2 stiffness categories less than prescribed), and one with a stiff prosthetic foot (+2 stiffness categories more than prescribed). This data will be used to test/develop the following aims: 1) Does foot stiffness change loading between the bone and implant during activities of daily living? 2) Does foot stiffness influence measures of function, pain, and biomechanics in patients with transtibial osseointegrated bone-anchored limbs differently than a socket prosthesis? 3) Does foot stiffness influence sensitivity, balance, and fall risk in patients using an osseointegrated bone-anchored limb different than a socket prosthesis? and 4) (exploratory) develop an optimization platform using computer models to determine the optimal foot stiffness that maximizes joint loading symmetry and minimizes metabolic cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes
- •> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group)
- •> 12-months limb amputation (Socket Control group)
- •Non-vascular amputation etiology
- •Low profile prosthetic foot (nominal)
- •Can walk unassisted for 5-minutes
- •> 18 years old
排除标准
- •Major amputation on contralateral limb
- •Vascular amputation etiology
- •Neurologic pathology that impairs coordination/balance
- •Regular assistive device use required for community ambulation
- •Inflammatory diseases or diabetes
- •Pregnancy or breastfeeding
研究组 & 干预措施
As-prescribed prosthetic foot stiffness
The prosthetic foot that is currently prescribed and used by each participant daily.
干预措施: As-prescribed prosthetic foot stiffness (Device)
Two prosthetic foot stiffness categories stiffer than the as-prescribed prosthetic foot stiffness
A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal (as-currently prescribed) foot.
干预措施: A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot (Device)
Two prosthetic foot stiffness categories softer than the as-prescribed prosthetic foot stiffness
A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal foot.
干预措施: A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot (Device)
结局指标
主要结局
Bone-Implant Stress/Strain Impulse during Decline Walking (internal)
时间窗: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks
Stress/strain impulse at the bone-implant interface (area under time series curve) will be calculated during the stance period of the decline walk (-5 degrees). Subject-specific finite element models will be developed for each bone-anchored limb participant to calculate this outcome. This will be done by including each participant's movement patterns, muscle forces, joint forces, bone geometry and bone health. Movement patterns, muscle forces, and joint loading will be calculated from musculoskeletal modeling using whole-body motion data collected from 70 wearable reflective markers (Vicon, Centennial, CO), ground reaction forces simultaneously collected from an instrumented treadmill (Bertec, Columbus, OH). Bone geometry and healthy will be determined from quantitative computed tomography bone scans.
Bone-Implant Stress/Strain Impulse during Decline Walking (internal)
时间窗: Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks
Stress/strain impulse at the bone-implant interface (area under time series curve) will be calculated during the stance period of the decline walk (-5 degrees). Subject-specific finite element models will be developed for each bone-anchored limb participant to calculate this outcome. This will be done by including each participant's movement patterns, muscle forces, joint forces, bone geometry and bone health. Movement patterns, muscle forces, and joint loading will be calculated from musculoskeletal modeling using whole-body motion data collected from 70 wearable reflective markers (Vicon, Centennial, CO), ground reaction forces simultaneously collected from an instrumented treadmill (Bertec, Columbus, OH). Bone geometry and healthy will be determined from quantitative computed tomography bone scans.
次要结局
- Sensory Threshold(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Postural Sway(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Reactive Postural Control Time(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Whole-Body Angular Momentum(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Self-Selected Gait Speed(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- L-Test Time(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Activities-Specific Balance Confidence Scale(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Bone Dynamic Stress/Strain Impulse (internal)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Implant Dynamic Stress/Strain Impulse (internal)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Prosthesis Force Impulse (external abutment)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Joint Reaction Force(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Prosthesis Force Impulse (external abutment)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Bone-Implant Dynamic Stress/Strain Impulse (internal)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Bone Dynamic Stress/Strain Impulse (internal)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Sensory Threshold(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Implant Dynamic Stress/Strain Impulse (internal)(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Acceptability of Intervention Measure(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Postural Sway(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- L-Test Time(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Activities-Specific Balance Confidence Scale(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Reactive Postural Control Time(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Whole-Body Angular Momentum(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Self-Selected Gait Speed(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Joint Reaction Force(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)
- Prosthetic Limb Users Survey of Mobility(Three laboratory visits, each lasting approximately 4 hours, spanning across approximately 6-8 weeks)