A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions
研究概览
地位
条件
详细说明
The purpose of this study is to investigate and compare the effects of the standard ischial containment (IC) socket to a sub-ischial (SI) socket design on the spinal and pelvic motions and leg length (LLD) discrepancies of transfemoral prosthesis users. Data will be collected from 2 groups of transfemoral prosthesis users (15 SI socket wearers and 15 IC socket wearers) and a group of 15 able-bodied (AB) control participants. Gait and standing analyses will be conducted on each participant using a marker based motion capture system. Prosthesis users will wear their own conventional sockets for the gait and standing analyses. Kinematic and kinetic data will be analyzed for differences between the 2 groups of socket wearers and will also be compared to the control group.
The specific aims and hypotheses of this project are:
Aim 1: To measure dynamic leg length and kinematics of the pelvis and spinal segments in unilateral, transfemoral prosthesis users during gait. Quantitative motion analyses will be performed on two groups of 15 research participants with lower limb amputation using 2 different socket designs (IC and SI) walking over level ground at three self-selected walking speeds (normal, moderately fast, fastest). Data will be compared between socket type and to an AB control group. Hypothesis 1a-IC socket wearers will have a greater anterior pelvic tilt compared to SI socket wearers and AB controls, and they will exhibit considerably greater rotations of the pelvis and spinal segments during walking. Hypothesis 1b-The EMG activity of the lumbar erector spinae for SI socket users will better approximate the patterns of AB controls as compared to IC socket wearers. Hypothesis 1c-The dynamic LLD will be greater for IC socket users compared to SI socket wearers and AB controls.
Aim 2: To measure pelvic orientation and static leg length in unilateral, transfemoral prosthesis users during standing. A multi-segment model of the spine and pelvis will be used to determine neutral spinal, pelvis, and prosthetic alignment during standing for the research and AB control participants. Hypothesis 2a-IC socket wearers will demonstrate greater anterior pelvic tilt during standing compared to SI socket wearers and control participants. Hypothesis 2b-The prosthetic and sound leg lengths for both prosthesis user groups will be within 1.0 cm of each other during standing.
Aim 3: To estimate joint contact forces in the legs and lower back of unilateral, transfemoral prosthesis users and controls during gait. Computational musculoskeletal simulations will be used to comprehensively evaluate the data from Aim 1 to compare the lumbar joint loads between IC and SI socket wearers. Hypothesis 3-IC socket wearers will exhibit greater lumbar joint loads than SI socket wearers.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Rebecca Stine, MS
- 电话号码:(312) 503-5726
- 邮箱:rebecca.stine@va.gov
研究联系人备份
- 姓名:Steven A Gard, PhD
- 电话号码:(312) 503-5718
- 邮箱:steven.gard@va.gov
学习地点
-
-
Illinois
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Chicago、Illinois、美国、60612
- Jesse Brown VA Medical Center, Chicago, IL
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接触:
- Rebecca Stine, MS
- 电话号码:(312) 503-5726
- 邮箱:rebecca.stine@va.gov
-
接触:
- Steven A Gard, PhD
- 电话号码:(312) 503-5718
- 邮箱:steven.gard@va.gov
-
首席研究员:
- Rebecca Stine, MS
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
For all participants:
- Ability to complete the experimental protocol without undue fatigue or health risks
- Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)
In addition for persons with lower limb amputation:
- Prosthesis user for a minimum of 2 years with their current socket design
- Good fit with either an ischial containment (IC) or sub-ischial (SI) socket
- Good skin integrity on their residual limb upon visual inspection
- Does not require the use of assistive devices to walk
Exclusion Criteria:
- Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)
- Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
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Ischial Containment Socket user
Person with unilateral transfemoral amputation wearing an ischial containment socket
|
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Sub-Ischial Socket user
Person with unilateral transfemoral amputation wearing a sub-ischial socket
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Able-bodied control
Person without an amputation
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
Anterior Pelvic Tilt will be calculated for all participants during the walking and standing trials.
Participants will walk along a 10 meter walkway at varying speeds.
Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
|
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
EMG activity will be assessed using surface electrodes attached bilaterally to the erector spinae at and below T12/L1 and on the external oblique muscle.
Data will be collected during the quantitative motion analysis.
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To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
|
Lumbar Flexion Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
Lumbar flexion will be calculated for all participants during the walking and standing trials.
Participants will walk along a 10 meter walkway at varying speeds.
Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
|
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
|
Hip Joint Range of Motion (ROM) between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
Hip Joint ROM will be calculated for all participants during the walking trials.
Participants will walk along a 10 meter walkway at varying speeds.
Quantitative motion analysis using a marker based motion measurement system will be used to calculate hip joint ROM.
|
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
|
Dynamic Leg Length Discrepancy (LLD) Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
Dynamic LLD will be calculated for all participants during the walking trials.
Participants will walk along a 10 meter walkway at varying speeds.
Quantitative motion analysis using a marker based motion measurement system will be used to calculated dynamic LLD.
|
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
|
Peak Lumbar Joint Loading Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
大体时间:To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
Lumbar joint loading during walking will be analyzed by performing musculoskeletal modeling simulations using data collected during the quantitative motion analysis.
|
To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
|
合作者和调查者
调查人员
- 首席研究员:Rebecca Stine, MS、Jesse Brown VA Medical Center, Chicago, IL
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RRD2-014-25W
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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