UnknownNot Applicable

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

United States40 participantsStarted 2016-08

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak Joint Powers

Timeframe: Assessed on day 1 (data collection day)

Concentric, Eccentric, and Total Joint and Limb Work.

Timeframe: Assessed on day 1 (data collection day)

Average Ground Reaction Forces.

Timeframe: Assessed on day 1 (data collection day)

Ground Reaction Force Impulses

Timeframe: Assessed on day 1 (data collection day)

Average Ground Reaction Force Magnitudes

Timeframe: Assessed on day 1 (data collection day)

Average Ground Reaction Force Loading Rates

Timeframe: Assessed on day 1 (data collection day)

Ground Reaction Forces

Timeframe: Assessed on day 1 (data collection day)

Trial details

NCT IDNCT02875197

SponsorRegis University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-09

Contact for this trial

Brian Baum, Ph.D.

303-964-6791 bbaum@regis.edu

View on ClinicalTrials.gov More Amputees trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Peak Joint Powers

Timeframe: Assessed on day 1 (data collection day)

Concentric, Eccentric, and Total Joint and Limb Work.

Timeframe: Assessed on day 1 (data collection day)

Average Ground Reaction Forces.

Timeframe: Assessed on day 1 (data collection day)

Ground Reaction Force Impulses

Timeframe: Assessed on day 1 (data collection day)

Average Ground Reaction Force Magnitudes

Timeframe: Assessed on day 1 (data collection day)

Average Ground Reaction Force Loading Rates

Timeframe: Assessed on day 1 (data collection day)

Ground Reaction Forces

Timeframe: Assessed on day 1 (data collection day)