Clinical trial NCT01404559: Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: Amputee
Transtibial
Military
Gait
Rehabilitation
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 28
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Obstacle Course Completion Time
timeFrame: 21 days total (7days per prosthetic foot condition)
measure: Bioenergetics Between Feet Components 21 Days After Fitting Prostheses
timeFrame: 21 days total (7days per prosthetic foot condition)
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: William S Quillen, PT,DPT,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: M. Jason Highsmith, PT,DPT,CP
role: STUDY_DIRECTOR
References: