Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities

University of South Florida

Status: Completed

Conditions: Amputation

Treatments: Device: Ossur Ceterus prosthetic foot; Device: Ossur Variflex prosthetic foot; Device: Endolite Elite Blade prosthetic foot

Study type: Interventional

Funder types: Other

Identifiers

NCT01404559

10193006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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28 participants in 4 patient groups

Prosthetic foot 1 (Ossur Variflex)

Active Comparator group

Description:

This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex).

Treatment:

Device: Ossur Variflex prosthetic foot

Prosthetic foot 2 (Ossur Ceterus)

Active Comparator group

Description:

This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2 (Ossur Ceterus).

Treatment:

Device: Ossur Ceterus prosthetic foot

Prosthetic foot 3 (Endolite Elite Blade)

Active Comparator group

Description:

This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3 (Endolite Elite Blade).

Treatment:

Device: Endolite Elite Blade prosthetic foot

Non-amputee controls

No Intervention group

Description:

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.