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

NCT02875197 | Unknown

• 1 other identifier: OP140064
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputees; Running With Prosthesis

Keywords

Kinetics; Biomechanics; Amputation; Prosthesis; Transtibial

Outcome Measures

Primary Outcomes (11)

• Peak Joint Powers

  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.

  Assessed on day 1 (data collection day)

• Concentric, Eccentric, and Total Joint and Limb Work.

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

  Assessed on day 1 (data collection day)

• Average Ground Reaction Forces.

  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.

  Assessed on day 1 (data collection day)

• Ground Reaction Force Impulses

  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.

  Assessed on day 1 (data collection day)

• Average Ground Reaction Force Magnitudes

  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.

  Assessed on day 1 (data collection day)

• Average Ground Reaction Force Loading Rates

  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.

  Assessed on day 1 (data collection day)

• Ground Reaction Forces

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

  Assessed on day 1 (data collection day)

• Normalized EMG Amplitudes

  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.

  Assessed on day 1 (data collection day)

• Lumbopelvic Kinematics

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

  Assessed on day 1 (data collection day)

• Joint Contact Forces over Stance

  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.

  Assessed on day 1 (data collection day)

• 50 Meter Dash

  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.

  Assessed on day 1 (data collection day)

Study Arms (2)

Healthy Controls

Males and females 18-50 years old Up to 20 able-bodied sex, age, height, and weight-matched subjects

Other: Running on a treadmill at 6 different speeds

Lower Extremity Amputees

Males \& females 18-50 years old * Must have a unilateral, transtibial amputation \& must have been prescribed a running-specific prosthesis * Subject with amputations resulting from trauma, congenital reasons, or cancer treatment unless cancer is in remission or treatments do not impact gait function * Physician approval to run * 4 months experience using a running-specific prosthesis

Other: Running on a treadmill at 6 different speeds

Interventions

Running on a treadmill at 6 different speeds OTHER

All subjects will be required to run at 6 prescribed speeds (2.5, 3.0, 3.5, 4.0, 5.0, and 6.0 m/sec) on a treadmill completing at least 10 consecutive strides, or running for 30 seconds.

Healthy Controls; Lower Extremity Amputees

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Up to twenty subjects with unilateral transtibial amputations will be recruited from the military, veteran, and civilian populations. Civilian individuals with lower extremity amputation (ILEA) will be recruited who match the age range of military service members commonly sustaining injuries resulting in amputation. Up to twenty able-bodied sex, age, height, and weight-matched subjects will serve as a control group to provide normative data for comparison.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regis University: lead
• Colorado School of Mines: collaborator

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

RECRUITING

Related Publications (50)

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Study Officials

• Brian Baum, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Baum, Ph.D.

CONTACT

303-964-6791; bbaum@regis.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: August 23, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)