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临床试验/NCT02875197
NCT02875197Unknown不适用

Comparing Running-Specific and Traditional Prostheses During Running: Assessing Performance and Risk

Regis University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Peak Joint Powers

研究概览

简要总结

The purpose of this research is to provide clinically, administratively, and field-relevant objective running outcomes by directly comparing running biomechanics of individuals with lower extremity amputation (ILEA) using RSPs (Running Specific Prostheses) and traditional prostheses. Within this purpose, the project has two specific aims:

Specific Aim 1: To compare RSPs and traditional prostheses with respect to running ability and performance

Specific Aim 2: To compare RSPs and traditional prostheses with respect to injury risks associated with running

Hypothesis 1a: RSPs will outperform traditional prostheses at all velocities as measured by kinetic data (ground reaction forces, joint powers, joint and limb work) and 50m dash time.

Hypothesis 1b: ILEA intact limbs and able-bodied control limbs will outperform residual limbs with RSPs and traditional prostheses at all velocities as measured by kinetic data.

Hypothesis 2: Running with RSPs will show reduced acute and chronic injury risks compared to traditional prostheses at all velocities as measured by loading rates, EMG amplitudes, lumbopelvic kinematics, and modeled joint loads.

详细描述

A. BACKGROUIND

Current knowledge and understanding of individuals with lower extremity amputations (ILEA) when running are limited with respect to biomechanical performance and injury risks. ILEA are able to run with both running-specific prostheses (RSPs) and traditional prostheses; however, direct comparisons of subjects running with each of these prosthetic designs do not exist. The reported literature examining one design or the other often do not have participants running at the same velocities. Additionally, when running velocities are similar between studies, the same variables are rarely investigated. This makes comparisons between RSPs and traditional prostheses exceedingly difficult, and drawing conclusions on both performance and injury risk is virtually impossible. Furthermore, no ILEA running studies to date have investigated muscle activities, nor have running simulations of musculoskeletal models been generated. These major gaps in research substantially limit the understanding of both performance and injury risk of ILEA running with different prosthetic designs. Gaining this knowledge will directly inform clinicians and administrators within the Department of Defense and Veterans Administration systems on prosthesis prescription for running at a range of speeds as well as for return to duty scenarios. Therefore, the proposed study will utilize motion capture, muscle activity, and musculoskeletal modeling techniques to directly compare performance and injury risks of ILEA running with both RSPs and traditional prostheses across a range of speeds. The investigators will also capture an able-bodied control group for normative comparisons. In doing so, this project directly attends to the OPORA's goals and needs at multiple levels.

B. RESEARCH STRATEGY:

Subjects Twelve subjects with unilateral transtibial amputations will be recruited from the military, veteran, and civilian populations. Twelve able-bodied sex, age, height, and weight-matched subjects will serve as a control group to provide normative data for comparison. All subjects must provide their informed consent prior to beginning any portion of the study and will have the option to discontinue the study at any time without penalty. All subjects must complete the Physical Activity Readiness Questionnaire (PAR-Q) prior to beginning the experiment. If subjects fail this questionnaire (by responding "yes" to any of the 7 questions), they will not be allowed to participate in the study until they provide documentation from a physician clearing them to participate.

Experimental Procedures A randomization computer program will determine the order of prosthetic foot conditions (RSP or traditional) for the ILEA subjects. All subjects (Controls and ILEA) will undergo 3D running analysis on an instrumented treadmill. A motion capture system will collect kinematic data (i.e. limb positions; joint angles, velocities, accelerations) at 200 Hz from reflective markers placed on specific body landmarks. On the amputated limb, the shank cluster will be placed laterally on the socket and a marker will be placed at the distal tip of the socket to define the long axis of the residual shank segment. For the RSP conditions, eight additional markers will be placed on the prosthesis keel. The marker on the most acute point of the prosthesis will define the prosthetic limb "ankle" joint. For the traditional prosthesis conditions, markers will be placed similarly to the intact foot.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with amputation must have a unilateral, transtibial amputation and must have been prescribed a running-specific prosthesis
  • Subject with amputations resulting from trauma, congenital reasons, or cancer treatment. If due to cancer, cancer must be in remission or subjects must not be undergoing treatments that could affect their gait function
  • Subjects with amputation must be cleared to run by a physician
  • Subjects with amputation must have at least 4 months experience using a running-specific prosthesis
  • All subjects must be between the ages of 18 and 50 years
  • Males and females who meet the inclusion/exclusion criteria are eligible to participate

排除标准

  • Subjects with any injury, affliction, or comorbidities to the limb(s) (other than the amputation) that impairs the gait pattern
  • Women who are pregnant, as pregnancy can affect the gait pattern
  • Amputations resulting from dysvascular disease as this may affect their gait function
  • Amputations resulting from cancer treatment where the subject is still undergoing treatment that may affect their gait function

结局指标

主要结局

Peak Joint Powers

时间窗: Assessed on day 1 (data collection day)

Peak joint power, calculated as the product of joint torque and joint angular velocity, is the highest power value achieved during the movement being evaluated and is measured in watts or watts per kg if normalized based on body weight.

Ground Reaction Force Impulses

时间窗: Assessed on day 1 (data collection day)

Vertical and anteroposterior ground reaction force impulses are determined by multiplying the impact force by the time over which the impact force acts. Impulses are stated in newton-seconds.

Lumbopelvic Kinematics

时间窗: Assessed on day 1 (data collection day)

Lumbopelvic kinematics is a postural evaluation of the lumbopelvic region expressing positions in degrees or radians.

Concentric, Eccentric, and Total Joint and Limb Work.

时间窗: Assessed on day 1 (data collection day)

Concentric, eccentric, and total joint and limb work is defined as force multiplied by displacement, and is expressed in watts.

Ground Reaction Forces

时间窗: Assessed on day 1 (data collection day)

Asymmetry in ground reaction forces and joint moments is determined by statistical differences between the left and right side.

Normalized EMG Amplitudes

时间窗: Assessed on day 1 (data collection day)

EMG amplitudes will be measured in millivolts and then normalized based on EMG amplitudes measured during maximum voluntary contractions using a scale of 0 to 1.

Average Ground Reaction Forces.

时间窗: Assessed on day 1 (data collection day)

Ground reaction force is the equaling and opposing force due to body mass passing through the foot to the ground surface; ground reaction forces is resolved into vertical (counteracting body weight) and horizontal (anterior and posterior) components. Ground reaction forces are expressed in newtons.

Joint Contact Forces over Stance

时间窗: Assessed on day 1 (data collection day)

Peak and average joint contact forces are forces that occur over stance (while there is contact between a limb and the ground). Peak forces are the highest force that occurs during stance, while average forces is the average of all force levels occuring during stance. Force measurements are expressed in newtons.

Average Ground Reaction Force Magnitudes

时间窗: Assessed on day 1 (data collection day)

Ground reaction forces is defined as the force exerted by the ground on the body in contact with the ground. Ground reaction force magnitudes will be averaged and expressed in newtons.

Average Ground Reaction Force Loading Rates

时间窗: Assessed on day 1 (data collection day)

Ground reaction force loading rate is the speed at which forces impact the body, and is calculated by dividing the maximal vertical force by the time needed to reach the maximal vertical force. It is expressed in body weights per millisecond.

50 Meter Dash

时间窗: Assessed on day 1 (data collection day)

A 50 meter dash effort will be used as an indicator of maximum running speed. It will be reported as an average of three trials and expressed as total time in seconds and as speed expressed in meters per second.

次要结局

未报告次要终点

研究者

发起方
Regis University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Baum

Assistant Professor

Regis University

研究点 (1)

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