AmputationNCT01404559
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
A study testing Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot and Endolite Elite Blade prosthetic foot in people with Amputation, run by University of South Florida at 1 site in United States.
Trial summary
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot and Endolite Elite Blade prosthetic foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jun 2013
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unilateral transtibial amputee ambulating on a K4 prosthesis for >1yr
- K4 functional level
- Currently active duty military or other uniformed service (e.g. police), recently separated Veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.)
- Schedule availability and willingness to comply with study protocols
- Aged < 45 years
- Medical clearance, within the last 6 months, for participation in vigorous physical activities
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- Currently active duty military, ROTC, or other uniformed service (e.g. police) or recently separated Veteran, or highly accomplished recreational athlete (e.g. marathoner)
- Schedule availability and willingness to comply with study protocols
- Aged < 45 years
- Medical clearance, within the last 6 months, for participation in vigorous physical activities
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic and Biomechanical Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.
Read the detailed description
Specific Aims
- Compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments.
- Compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups.
Hypotheses:
Prosthetic feet with shock absorbing and torsional features will perform better in field activities. Prosthetic feet with high energy return and low mass will perform better during treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects.
Relevance:
This study has the potential to quantify differences between highly mobile amputees and non-amputees. Additionally, it will provide objective measures of how different prostheses may enhance mobility of soldiers with amputations. The study will compare laboratory and field measures to indicate which conditions increase efficiency of prostheses during rapidly changing mobility demands. This has the potential to permit retention of already trained soldiers.
- Conditions
- Amputation
- Being tested
- Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot, Endolite Elite Blade prosthetic foot
- Keywords
- Amputee, Transtibial, Military, Gait, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ossur Variflex prosthetic footDevice
Lightweight energy-storing prosthetic foot
Ossur Ceterus prosthetic footDevice
Shock-absorbing prosthetic foot
Endolite Elite Blade prosthetic footDevice
Multi-axial prosthetic foot
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic foot 1 (Ossur Variflex) | Active comparator | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex). Receives: Device: Ossur Variflex prosthetic foot |
| Prosthetic foot 2 (Ossur Ceterus) | Active comparator | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus). Receives: Device: Ossur Ceterus prosthetic foot |
| Prosthetic foot 3 (Endolite Elite Blade) | Active comparator | This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade). Receives: Device: Endolite Elite Blade prosthetic foot |
| Non-amputee controls | No intervention | This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obstacle Course Completion Time
Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.
Measured: 21 days total (7days per prosthetic foot condition)
Bioenergetics Between Feet Components 21 Days After Fitting Prostheses
Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.
Measured: 21 days total (7days per prosthetic foot condition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJul 2012
- Primary completionJun 2013
- Study completionJun 2013
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 AmputationStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Quillen, University of South Florida
- Investigators
- William S Quillen, PT,DPT,PhD, Principal investigator, University of South FloridaM. Jason Highsmith, PT,DPT,CP, Study director, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404559
- Sponsor's protocol ID
- 10193006
- Status last verified
- Dec 2014
- First submitted
- 31 May 2011
- Last updated
- 15 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Biomechanical Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
- ClinicalTrials.gov ID
- NCT01404559
- Acronym / sponsor ID
- 10193006
- Conditions
- Amputation
- Keywords
- Amputee, Transtibial, Military, Gait, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Posted 15 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular multi-function prosthetic feet that would facilitate return to duty for soldiers with amputations.
Detailed description
Specific Aims
- Compare the effectiveness of popular prostheses for improving performance in physically demanding tasks and environments.
- Compare amputee performance to a group of high-functioning non-amputees to determine performance differences between the groups.
Hypotheses:
Prosthetic feet with shock absorbing and torsional features will perform better in field activities. Prosthetic feet with high energy return and low mass will perform better during treadmill running. Non-amputee controls will demonstrate superior performance in all outcomes in both field and laboratory environments compared to amputee subjects.
Relevance:
This study has the potential to quantify differences between highly mobile amputees and non-amputees. Additionally, it will provide objective measures of how different prostheses may enhance mobility of soldiers with amputations. The study will compare laboratory and field measures to indicate which conditions increase efficiency of prostheses during rapidly changing mobility demands. This has the potential to permit retention of already trained soldiers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prosthetic foot 1 (Ossur Variflex) | Active comparator | Device: Ossur Variflex prosthetic footThis arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex). |
| Prosthetic foot 2 (Ossur Ceterus) | Active comparator | Device: Ossur Ceterus prosthetic footThis arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus). |
| Prosthetic foot 3 (Endolite Elite Blade) | Active comparator | Device: Endolite Elite Blade prosthetic footThis arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade). |
| Non-amputee controls | No intervention | –This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Unilateral transtibial amputee ambulating on a K4 prosthesis for >1yr
- K4 functional level
- Currently active duty military or other uniformed service (e.g. police), recently separated Veteran, or strong high-performance athletic history as an amputee (e.g. ranked triathlete, paralympian, etc.)
- Schedule availability and willingness to comply with study protocols
- Aged < 45 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ossur Variflex prosthetic footLightweight energy-storing prosthetic foot | Device | Prosthetic foot 1 (Ossur Variflex) |
| Ossur Ceterus prosthetic footShock-absorbing prosthetic foot | Device | Prosthetic foot 2 (Ossur Ceterus) |
| Endolite Elite Blade prosthetic footMulti-axial prosthetic foot | Device | Prosthetic foot 3 (Endolite Elite Blade) |
Primary outcome
Obstacle Course Completion Time
Time frame: 21 days total (7days per prosthetic foot condition)
Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.
Bioenergetics Between Feet Components 21 Days After Fitting Prostheses
Time frame: 21 days total (7days per prosthetic foot condition)
Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
- 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.
William S Quillen, PT,DPT,PhD principal investigator
University of South Florida
M. Jason Highsmith, PT,DPT,CP study director
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot and Endolite Elite Blade prosthetic foot in people with Amputation, run by University of South Florida 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 10 inclusion and 0 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 15 Dec 2014. 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 15 Dec 2014). 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?
Obstacle Course Completion Time (time frame: 21 days total (7days per prosthetic foot condition)). The study lists 2 primary outcomes in all. 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 15 Dec 2014.