ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 36 for:    Recruiting, Not yet recruiting, Available Studies | "Amputees"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02875197
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
Colorado School of Mines
Information provided by (Responsible Party):
Brian Baum, Regis University

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.


Condition or disease Intervention/treatment
Amputees Running With Prosthesis Other: Running on a treadmill at 6 different speeds

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Comparing Running-Specific and Traditional Prostheses During Running: Assessing Performance and Risk
Study Start Date : August 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Group/Cohort Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Peak Joint Powers [ Time Frame: 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.

  2. Concentric, Eccentric, and Total Joint and Limb Work. [ Time Frame: 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.

  3. Average Ground Reaction Forces. [ Time Frame: 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.

  4. Ground Reaction Force Impulses [ Time Frame: 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.

  5. Average Ground Reaction Force Magnitudes [ Time Frame: 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.

  6. Average Ground Reaction Force Loading Rates [ Time Frame: 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.

  7. Ground Reaction Forces [ Time Frame: 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.

  8. Normalized EMG Amplitudes [ Time Frame: 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.

  9. Lumbopelvic Kinematics [ Time Frame: Assessed on day 1 (data collection day) ]
    Lumbopelvic kinematics is a postural evaluation of the lumbopelvic region expressing positions in degrees or radians.

  10. Joint Contact Forces over Stance [ Time Frame: 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.

  11. 50 Meter Dash [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875197


Contacts
Contact: Brian Baum, Ph.D. 303-964-6791 bbaum@regis.edu

Locations
United States, Colorado
Regis University Recruiting
Denver, Colorado, United States, 80221
Contact: Brian Baum, Ph.D.    303-964-6791    bbaum@regis.edu   
Sponsors and Collaborators
Regis University
Colorado School of Mines
Investigators
Principal Investigator: Brian Baum, Ph.D. Assistant Professor

Publications of Results:
Baum BS. Kinetics in individuals with unilateral transtibial amputations using running-specific prostheses, Dissertation, University of Maryland, College Park, Md., 2012.
Brüggemann GP, Arampatzis A, Emrich F, Potthast W. Biomechanics of double transtibial amputee sprinting using dedicated sprinting prostheses. Sports Technol 1: 220-227, 2009.
Feldman DR, Gonzalez-Fernandez M, Singla AA, Krabak BJ, Singh S, Krabak J, Singh S. Hip and pelvis injuries in special populations, in: Seidenberg P, Bowen JD. (Eds.), The Intact Hip and Pelvis in Sports Medicine and Primary Care. Springer, New York, 187-205, 2010.
Hobara H, Baum BS, Kwon HJ, Shim JK. Running mechanics in amputee runners using running-specific prostheses. Jap J Biomech Sports Exerc 17: 53-61, 2013.
Zatsiorsky VM. Kinetics of Human Motion. Human Kinetics. Champaign, IL, 2002.
Zipp P. Recommendations for the standardization of lead positions in surface electromyography. Eur J Appl Physiol Occup Physiol 50: 41-54, 1982.
Kendall FP, McCreary EK, Provance PG, Rodgers MM, Romani WA. Muscles: Testing and Function, with Posture and Pain, 5th ed. Lippincott Williams & Wilkins, Baltimore, MD, 2005.
Winter DA. Biomechanics and Motor Control of Human Movement. John Wiley & Sons, Hoboken, NJ, 2009.
Smith JD. Effects of prosthesis inertia on the mechanics and energetics of amputee locomotion. Dissertation. The Pennsylvania State University, 2008.

Responsible Party: Brian Baum, Assistant Professor, Regis University
ClinicalTrials.gov Identifier: NCT02875197     History of Changes
Other Study ID Numbers: OP140064
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brian Baum, Regis University:
Kinetics
Biomechanics
Amputation
Prosthesis
Transtibial