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

Status unconfirmed

Conditions studied: Amputees, Running With Prosthesis

In brief

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.

Key facts

Study ID

NCT02875197

Run by

Regis University

People needed

40

Starts

2016-08-01

Expected to finish

2018-09-01

Last updated by the study team

2017-10-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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
• Males and females who meet the inclusion/exclusion criteria are eligible to participate

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

Where it is running

• Regis University — Denver, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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