Trial Outcomes & Findings for Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities (NCT NCT01404559)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

21 days total (7days per prosthetic foot condition)

Results posted on

2014-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	Prosthetic Foot 1 (Ossur Variflex) This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week). Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot	Prosthetic Foot 2 (Ossur Ceterus) This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week). Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot	Prosthetic Foot 3 (Endolite Elite Blade) This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week). Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot	Non-amputee Controls 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. No intervention. Control group.: There are no interventions in this observational arm of the study.
Overall Study STARTED	5	5	4	14
Overall Study COMPLETED	5	5	4	14
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transtibial Amputees n=14 Participants This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.	Non-amputee Controls n=14 Participants 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. No intervention. Control group.: There are no interventions in this observational arm of the study.	Total n=28 Participants Total of all reporting groups
Age, Continuous	31.4 years STANDARD_DEVIATION 5.9 • n=5 Participants	38.5 years STANDARD_DEVIATION 5.1 • n=7 Participants	33.2 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthetic Foot 1 (Ossur Variflex) n=14 Participants This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1. Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot	Prosthetic Foot 2 (Ossur Ceterus) n=14 Participants This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2. Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot	Prosthetic Foot 3 (Endolite Elite Blade) n=14 Participants This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3. Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot	Non-amputee Controls n=14 Participants 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. No intervention. Control group.: There are no interventions in this observational arm of the study.
Obstacle Course Completion Time	425 seconds Standard Deviation 144	444 seconds Standard Deviation 220	419 seconds Standard Deviation 130	287 seconds Standard Deviation 58

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prosthetic Foot 1 (Ossur Variflex) n=14 Participants This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1. Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot	Prosthetic Foot 2 (Ossur Ceterus) n=14 Participants This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2. Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot	Prosthetic Foot 3 (Endolite Elite Blade) n=14 Participants This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3. Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot	Non-amputee Controls n=14 Participants 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. No intervention. Control group.: There are no interventions in this observational arm of the study.
Bioenergetics Between Feet Components 21 Days After Fitting Prostheses	15.7 ml O2/kg/min Standard Deviation 2.29	15.57 ml O2/kg/min Standard Deviation 2.26	15.05 ml O2/kg/min Standard Deviation 2.17	11.05 ml O2/kg/min Standard Deviation 1.89

Adverse Events

Unilateral Transtibial Amputees

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William S. Quillen

University of South Florida

Phone: 8139749863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place