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

NCT01404559 | Completed Results DMC

• 1 other identifier: 10193006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Amputee; Transtibial; Military; Gait; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  21 days total (7days per prosthetic foot condition)

Study Arms (4)

Prosthetic foot 1 (Ossur Variflex)

ACTIVE COMPARATOR

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

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).

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).

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.

Interventions

Ossur Variflex prosthetic foot DEVICE

Lightweight energy-storing prosthetic foot

Prosthetic foot 1 (Ossur Variflex)

Ossur Ceterus prosthetic foot DEVICE

Shock-absorbing prosthetic foot

Prosthetic foot 2 (Ossur Ceterus)

Endolite Elite Blade prosthetic foot DEVICE

Multi-axial prosthetic foot

Prosthetic foot 3 (Endolite Elite Blade)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Results Point of Contact

• Title: William S. Quillen
• Organization: University of South Florida

wquillen@health.usf.edu

8139749863

Study Officials

• William S Quillen, PT,DPT,PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• M. Jason Highsmith, PT,DPT,CP

  University of South Florida

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean & Professor

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: July 28, 2011
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 15, 2014
• Results First Posted: December 15, 2014

Record last verified: 2014-12

Locations

US (1)