Recruiting

Running-Specific & Traditional

Sponsor:

Regis University

Code:

NCT02875197

Conditions

Amputees

Running With Prosthesis

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Running on a treadmill at 6 different speeds

Study Details

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

Study ID

NCT02875197

Start date

Aug, 2016

Status verified date

Sep, 2017

Completion date

Sep, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

Males and females 18-50 years old

Up to 20 able-bodied sex, age, height, and weight-matched subjects

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

Interventions

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 measure

  • Peak Joint Powers [ Time Frame: Assessed on day 1 (data collection day) ]
  • Concentric, Eccentric, and Total Joint and Limb Work. [ Time Frame: Assessed on day 1 (data collection day) ]
  • Average Ground Reaction Forces. [ Time Frame: Assessed on day 1 (data collection day) ]
  • Ground Reaction Force Impulses [ Time Frame: Assessed on day 1 (data collection day) ]
  • Average Ground Reaction Force Magnitudes [ Time Frame: Assessed on day 1 (data collection day) ]
  • Average Ground Reaction Force Loading Rates [ Time Frame: Assessed on day 1 (data collection day) ]
  • Ground Reaction Forces [ Time Frame: Assessed on day 1 (data collection day) ]
  • Normalized EMG Amplitudes [ Time Frame: Assessed on day 1 (data collection day) ]
  • Lumbopelvic Kinematics [ Time Frame: Assessed on day 1 (data collection day) ]
  • Joint Contact Forces over Stance [ Time Frame: Assessed on day 1 (data collection day) ]
  • 50 Meter Dash [ Time Frame: Assessed on day 1 (data collection day) ]

Central Contacts and Locations

Central contacts

Brian Baum, Ph.D.

303-964-6791bbaum@regis.edu

Locations

Regis University

Recruiting

Denver, Colorado, United States, 80221

Contacts

Brian Baum, Ph.D.

303-964-6791bbaum@regis.edu

More Information

Sponsor

Regis University

Last update posted

Oct 2, 2017

Last verified

Sep, 2017

Keywords

  • Kinetics
  • Biomechanics
  • Amputation
  • Prosthesis
  • Transtibial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regis University on 2017-10-02.