Amputation, TraumaticNCT02318979
What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
A study testing Otto Bock prosthesis, Ossur prosthesis and Freedom Innovations prosthesis in people with Amputation, Traumatic and Traumatic Amputation of Lower Extremity, run by VA Eastern Colorado Health Care System at 1 site in United States.
Trial summary
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Traumatic, Traumatic Amputation of Lower Extremity, Wounds and Injuries
- What is being tested?
- Otto Bock prosthesis, Ossur prosthesis and Freedom Innovations prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- bilateral or unilateral transtibial amputation
- at least one year of running experience using running-specific prostheses
- 18-55 years old
- no current problems with their prosthesis or residual limb
- at a K4 Medicare Functional Classification Level
Who cannot join
- Cardiovascular, pulmonary, or neurological disease or disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.
- Being tested
- Otto Bock prosthesis, Ossur prosthesis, Freedom Innovations prosthesis
- Medical subject headings
- Amputation, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otto Bock prosthesisDevice
Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Ossur prosthesisDevice
Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
Freedom Innovations prosthesisDevice
Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
| Study group | Role | What they receive |
|---|---|---|
| Running | Experimental | Participants will run on an instrumented treadmill at one speed using three different prostheses. Receives: Device: Otto Bock prosthesis; Device: Ossur prosthesis; Device: Freedom Innovations prosthesis |
| Sprinting | Experimental | Participants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed. Receives: Device: Otto Bock prosthesis; Device: Ossur prosthesis; Device: Freedom Innovations prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanics
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
Measured: 4-10 days
Secondary outcomes (2)
Metabolic Demand
The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.
Measured: 4 days
Top Speed
The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.
Measured: 4-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Alena M Grabowski, PhD, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318979
- Sponsor's protocol ID
- W81XWH-11-2-0222
- Status last verified
- May 2019
- First submitted
- 12 Dec 2014
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Optimal Stiffness and Height of a Running-specific Prosthesis?
- ClinicalTrials.gov ID
- NCT02318979
- Acronym / sponsor ID
- W81XWH-11-2-0222
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Oct 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. The investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. This data will be used to understand the effects of running prostheses. Then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at one speed and we measured metabolic rates and biomechanics. 10 athletes with a unilateral and 5 athletes with bilateral transtibial amputations used 15 different running-specific prosthetic configurations while they ran at multiple speeds and we measured top speeds and biomechanics.
| Arm | Type | Receives |
|---|---|---|
| Running | Experimental | Device: Otto Bock prosthesis, Device: Ossur prosthesis, Device: Freedom Innovations prosthesisParticipants will run on an instrumented treadmill at one speed using three different prostheses. |
| Sprinting | Experimental | Device: Otto Bock prosthesis, Device: Ossur prosthesis, Device: Freedom Innovations prosthesisParticipants will run on an instrumented treadmill at a range of speeds from a jogging speed up to top speed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- bilateral or unilateral transtibial amputation
- at least one year of running experience using running-specific prostheses
- 18-55 years old
- no current problems with their prosthesis or residual limb
- at a K4 Medicare Functional Classification Level
Key exclusion criteria (1 listed)
- Cardiovascular, pulmonary, or neurological disease or disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Otto Bock prosthesisParticipants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter. | Device | Running, Sprinting |
| Ossur prosthesisParticipants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter. | Device | Running, Sprinting |
| Freedom Innovations prosthesisParticipants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter. | Device | Running, Sprinting |
Primary outcome
Biomechanics
Time frame: 4-10 days
The investigators will measure stance average vertical ground reaction forces during running and sprinting.
2 secondary outcomes
Metabolic Demand
Time frame: 4 days
Top Speed
Time frame: 4-10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alena M Grabowski, PhD principal investigator
VA Eastern Colorado Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otto Bock prosthesis, Ossur prosthesis and Freedom Innovations prosthesis in people with Amputation, Traumatic and Traumatic Amputation of Lower Extremity, run by VA Eastern Colorado Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanics (time frame: 4-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.