Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
This study is currently recruiting participants.
Verified January 2013 by University of South Florida
Sponsor:
University of South Florida
Information provided by (Responsible Party):
William Quillen, University of South Florida
ClinicalTrials.gov Identifier:
NCT01404559
First received: May 31, 2011
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Amputation |
Device: Ossur Ceterus prosthetic foot Device: Ossur Variflex prosthetic foot Device: Freedom Innovations Silhouette VS |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- Biomechanics between feet components 21 days after fitting prostheses [ Time Frame: 21 days ] [ Designated as safety issue: No ]Measures of joint movement and joint forces.
- Preference between feet components 21 days after fitting prostheses [ Time Frame: 21 days ] [ Designated as safety issue: No ]Interview and survey to determine which components are preferred by users.
- Bioenergetics between feet components 21 days after fitting prostheses [ Time Frame: 21 days ] [ Designated as safety issue: No ]Measures of energy expenditure and perceived exertion.
| Estimated Enrollment: | 28 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Prosthetic condition 1
Subjects are fitted with the first of 3 prostheses which they will test.
|
Device: Ossur Ceterus prosthetic foot
Lightweight energy-storing prosthesis.
|
|
Active Comparator: Prosthetic condition 2
Subjects are fitted with the second of 3 prostheses which they will test.
|
Device: Ossur Variflex prosthetic foot
Shock-absorbing prosthesis.
|
|
Active Comparator: Prosthetic condition 3
Subjects are fitted with the third of 3 prostheses which they will test.
|
Device: Freedom Innovations Silhouette VS
Multi-axial prosthesis.
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria (Amputees):
- 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
Inclusion Criteria (Non-amputees)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404559
Contacts
| Contact: M. Jason Highsmith, PT,DPT,CP | 813-974-3806 | mhighsmi@health.usf.edu |
Locations
| United States, Florida | |
| University of South Florida | Recruiting |
| Tampa, Florida, United States, 33612 | |
Sponsors and Collaborators
University of South Florida
Investigators
| Principal Investigator: | William S Quillen, PT,DPT,PhD | University of South Florida |
| Study Director: | M. Jason Highsmith, PT,DPT,CP | University of South Florida |
More Information
No publications provided
| Responsible Party: | William Quillen, Associate Dean & Professor, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01404559 History of Changes |
| Other Study ID Numbers: | 10193006 |
| Study First Received: | May 31, 2011 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
Amputee Transtibial Military Gait Rehabilitation |
ClinicalTrials.gov processed this record on May 21, 2013