Trial Outcomes & Findings for Comparative Performance of Dynamic Elastic Response Feet (NCT NCT02542761)

NCT ID: NCT02542761

Last Updated: 2018-09-20

Results Overview

The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: After approximate 4 week acclimation period
• Results posted on: 2018-09-20

Participant Flow

Subjects were recruited at Mayo Clinic in Rochester, Minnesota.

Participant milestones

Measure	CFPF First, Then FPF After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF). Fiberglass Composite foot: The Rush foot is a fiberglass composite energy storage and return prosthetic foot. Carbon Fiber Composite Foot: All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	FPF First, Then CFPF After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF). Fiberglass Composite foot: The Rush foot is a fiberglass composite energy storage and return prosthetic foot. Carbon Fiber Composite Foot: All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
Acclimation Period 1 STARTED	5	5
Acclimation Period 1 COMPLETED	5	5
Acclimation Period 1 NOT COMPLETED	0	0
First Intervention STARTED	5	5
First Intervention COMPLETED	5	5
First Intervention NOT COMPLETED	0	0
Acclimation Period 2 STARTED	5	5
Acclimation Period 2 COMPLETED	5	5
Acclimation Period 2 NOT COMPLETED	0	0
Second Intervention STARTED	5	5
Second Intervention COMPLETED	5	5
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Performance of Dynamic Elastic Response Feet

Baseline characteristics by cohort

Measure	Entire Study Population n=10 Participants Includes groups studying CFPF first and FPF first.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	49 years STANDARD_DEVIATION 9 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	10 Participants n=93 Participants
Body Mass Index (BMI)	29 kg/m^2 STANDARD_DEVIATION 7 • n=93 Participants

PRIMARY outcome

Timeframe: After approximate 4 week acclimation period

The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.

Outcome measures

Measure	Carbon Fiber Prosthetic Foot (CFPF) n=10 Participants All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	Fiberglass Prosthetic Foot (FPF) n=10 Participants The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
Peak Ankle Dorsiflexion During Stance Level ground, controlled speed	18.871 degrees Standard Deviation 2.549	22.023 degrees Standard Deviation 2.654
Peak Ankle Dorsiflexion During Stance Level ground, self-selected speed	18.657 degrees Standard Deviation 2.818	22.016 degrees Standard Deviation 2.638
Peak Ankle Dorsiflexion During Stance Ramp Down	17.09 degrees Standard Deviation 3.22	19.98 degrees Standard Deviation 3.18
Peak Ankle Dorsiflexion During Stance Ramp Up	20.45 degrees Standard Deviation 4.38	23.80 degrees Standard Deviation 4.09

SECONDARY outcome

Timeframe: After approximate 4 week acclimation period

Peak ankle plantar flexor moment means the peak force of the movement of the foot in which the foot or toes flex downward toward the sole. The unit of measurement for this variable is Nm/kg = 1 nanometer / (kilogram unit).

Outcome measures

Measure	Carbon Fiber Prosthetic Foot (CFPF) n=10 Participants All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	Fiberglass Prosthetic Foot (FPF) n=10 Participants The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
Peak Ankle Plantar Flexor Moment During Stance Level ground, self selected speed	1.3446 Nm/kg Standard Deviation 0.1306	1.4451 Nm/kg Standard Deviation 0.2333
Peak Ankle Plantar Flexor Moment During Stance Level ground, normalized speed	1.3732 Nm/kg Standard Deviation 0.1915	1.4418 Nm/kg Standard Deviation 0.2361
Peak Ankle Plantar Flexor Moment During Stance Ramp Down	1.0989 Nm/kg Standard Deviation 0.1765	1.1662 Nm/kg Standard Deviation 0.2197
Peak Ankle Plantar Flexor Moment During Stance Ramp Up	1.4787 Nm/kg Standard Deviation 0.2244	1.5251 Nm/kg Standard Deviation 0.2922

SECONDARY outcome

Timeframe: After approximate 4 week acclimation period

Joint power (P) is the "dot product" of the moment (M) at the joint and the angular velocity (w) of the distal segment with respect to the proximal segment (i.e., P = M · w). Depending on the direction of the moment and the direction of the angular velocity, the power can be positive or negative. If the signs for the moment and angular velocity are both positive or both negative, the power is positive. If the signs for the moment and angular velocity are different, the power is negative. The unit of measurement for this variable is W/kg = watts/kilogram.

Outcome measures

Measure	Carbon Fiber Prosthetic Foot (CFPF) n=10 Participants All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	Fiberglass Prosthetic Foot (FPF) n=10 Participants The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
Peak Ankle Power Generation Level ground, controlled speed	1.130 W/kg Standard Deviation 0.321	1.605 W/kg Standard Deviation 0.371
Peak Ankle Power Generation Level ground, self-selected speed	1.080 W/kg Standard Deviation 0.318	1.475 W/kg Standard Deviation 0.347
Peak Ankle Power Generation Ramp Down	0.979 W/kg Standard Deviation 0.347	1.292 W/kg Standard Deviation 0.323
Peak Ankle Power Generation Ramp Up	0.999 W/kg Standard Deviation 0.416	1.331 W/kg Standard Deviation 0.491

SECONDARY outcome

Timeframe: After approximate 4 week acclimation period

A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is measuring the angle of knee flexion during the swing phase.

Outcome measures

Measure	Carbon Fiber Prosthetic Foot (CFPF) n=10 Participants All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	Fiberglass Prosthetic Foot (FPF) n=10 Participants The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
Peak Knee Flexion During Swing Level ground, controlled speed	69.61 degrees Standard Deviation 4.92	71.52 degrees Standard Deviation 7.70
Peak Knee Flexion During Swing Level ground, self-selected speed	67.38 degrees Standard Deviation 4.72	70.08 degrees Standard Deviation 6.73
Peak Knee Flexion During Swing Ramp Down	72.42 degrees Standard Deviation 5.75	73.57 degrees Standard Deviation 6.44
Peak Knee Flexion During Swing Ramp Up	69.63 degrees Standard Deviation 6.91	71.45 degrees Standard Deviation 7.37

SECONDARY outcome

Timeframe: After approximate 4 week acclimation period

A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is expressed as a percentage of the gait cycle.

Outcome measures

Measure	Carbon Fiber Prosthetic Foot (CFPF) n=10 Participants All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	Fiberglass Prosthetic Foot (FPF) n=10 Participants The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
Time of Peak Knee Flexion During Swing Level ground, self-selected speed	72.132 percentage of gait cycle Standard Deviation 1.975	72.293 percentage of gait cycle Standard Deviation 2.087
Time of Peak Knee Flexion During Swing Level ground, controlled speed	71.841 percentage of gait cycle Standard Deviation 1.782	72.077 percentage of gait cycle Standard Deviation 2.018
Time of Peak Knee Flexion During Swing Ramp Down	67.794 percentage of gait cycle Standard Deviation 2.409	67.194 percentage of gait cycle Standard Deviation 1.773
Time of Peak Knee Flexion During Swing Ramp Up	75.883 percentage of gait cycle Standard Deviation 2.871	75.653 percentage of gait cycle Standard Deviation 2.481

SECONDARY outcome

Timeframe: After approximate 4 week acclimation period

Population: Some participants did not complete some of the scales in the questionnaire.

The PEQ is a self-administered questionnaire composed of nine scales computed from forty-two items (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Each question uses a visual analog scale format, scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the measured from the left (0-100). The 0 side of the scale is very negative (terrible) and the 100 side of the scale is very positive (excellent). Each scale is reported separately, with a higher score indicating more satisfaction with the prosthesis itself or quality of life.

Outcome measures

Measure	Carbon Fiber Prosthetic Foot (CFPF) n=10 Participants All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.	Fiberglass Prosthetic Foot (FPF) n=10 Participants The Rush87 foot is a fiberglass composite energy storage and return prosthetic foot.
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Ambulation	79.64 units on a scale Standard Deviation 16.49	84.74 units on a scale Standard Deviation 14.01
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Appearance	77.89 units on a scale Standard Deviation 17.51	85.83 units on a scale Standard Deviation 13.80
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Frustration	78.25 units on a scale Standard Deviation 14.94	83.00 units on a scale Standard Deviation 22.66
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Perceived Response	95.71 units on a scale Standard Deviation 7.18	93.71 units on a scale Standard Deviation 7.62
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Residual Limb Health	75.78 units on a scale Standard Deviation 14.99	77.10 units on a scale Standard Deviation 9.21
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Social Burden	91.18 units on a scale Standard Deviation 14.48	92.57 units on a scale Standard Deviation 14.59
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Sounds	66.45 units on a scale Standard Deviation 27.24	74.50 units on a scale Standard Deviation 24.57
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Utility	73.31 units on a scale Standard Deviation 20.93	83.97 units on a scale Standard Deviation 14.36
Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ) Well Being	84.15 units on a scale Standard Deviation 15.39	92.85 units on a scale Standard Deviation 8.95

Adverse Events

Carbon Fiber Prosthetic Foot (CFPF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fiberglass Prosthetic Foot (FPF)

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

Kenton Kaufman, Ph.D.

Mayo Clinic

Phone: 507-266-0136

Email: Kaufman.Kenton@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place