Trial Outcomes & Findings for No Power Bionic Lower Extremity Prosthesis (NCT NCT04070105)

NCT ID: NCT04070105

Last Updated: 2024-03-27

Results Overview

Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: All conditions were complete during 3 lab visits, approximately four hours long
• Results posted on: 2024-03-27

Participant Flow

Participants enrolled in the study and tested a prototype foot to assess stiffness. A foot was then manufactured for them specifically. Due to COVID19 pauses in collection there was a significant gap between manufacturing the prosthetic feet and human subjects testing. One participant was no longer available to complete laboratory testing. The order of testing was randomized between participants, such that all participants completed testing in a different order.

Participant milestones

Measure	CAESAR, Then Prescribed, Then AllPro Participants will walk and run with three prostheses in random order	CAESAR, Then AllPro, Then Prescribed Participants will walk and run with three prostheses in random order	Prescribed, Then AllPro, Then CAESAR Participants will walk and run with three prostheses in random order	Prescribed, Then CAESAR, Then AllPro Participants will walk and run with three prostheses in random order	AllPro, Then CAESAR, Then Prescribed Participants will walk and run with three prostheses in random order	AllPro, Then Prescribed, Then CAESAR Participants will walk and run with three prostheses in random order
Overall Study STARTED	0	2	1	1	1	1
Overall Study COMPLETED	0	2	1	1	1	0
Overall Study NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Measure	CAESAR, Then Prescribed, Then AllPro Participants will walk and run with three prostheses in random order	CAESAR, Then AllPro, Then Prescribed Participants will walk and run with three prostheses in random order	Prescribed, Then AllPro, Then CAESAR Participants will walk and run with three prostheses in random order	Prescribed, Then CAESAR, Then AllPro Participants will walk and run with three prostheses in random order	AllPro, Then CAESAR, Then Prescribed Participants will walk and run with three prostheses in random order	AllPro, Then Prescribed, Then CAESAR Participants will walk and run with three prostheses in random order
Overall Study Lost to Follow-up	0	0	0	0	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Prosthetic Foot Intervention n=6 Participants Participants will walk and run with one of three different prostheses, their standard of care running and walking prostheses, a new prosthesis designed to switch orientation of the foot with a push of a button, and a high activity foot (AllPro, Fillauer, Chattanooga, TN) Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button Conventional Prosthetic Foot: This is a commercial prosthetic foot that has been prescribed to the individual Commercial High Activity Foot: This is a commercially available prosthetic foot designed for high-activity individuals
Age, Continuous	48.7 years STANDARD_DEVIATION 14.0 • n=6 Participants
Sex: Female, Male Female	1 Participants n=6 Participants
Sex: Female, Male Male	5 Participants n=6 Participants
Region of Enrollment United States	6 participants n=6 Participants
Height (m)	1.75 meters STANDARD_DEVIATION 0.10 • n=6 Participants
Weight (kg)	80.0 kg STANDARD_DEVIATION 8.3 • n=6 Participants

PRIMARY outcome

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Population: Participants walked with each of three feet: prescribed, CAESAR, and AllPro

Participants will walk over sensors that measure the force under their foot. Peak ground reaction force in the anterior direction is measured in Newtons and then divided by the individual's body weight (BW). The resultant force is measured in Body-weights.

Outcome measures

Measure	Prescribed n=5 Participants This is a commercial prosthetic foot that has been prescribed to the individual	AllPro n=5 Participants This is a commercially available prosthetic foot designed for high-activity individuals	CAESAR n=5 Participants Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking	.175 Body-weights Standard Deviation 0.043	.166 Body-weights Standard Deviation 0.022	.166 Body-weights Standard Deviation 0.013

PRIMARY outcome

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)

Outcome measures

Measure	Prescribed n=5 Participants This is a commercial prosthetic foot that has been prescribed to the individual	AllPro n=5 Participants This is a commercially available prosthetic foot designed for high-activity individuals	CAESAR n=5 Participants Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Participants Perceived Comfort When Using Different Prosthetic Feet During Walking	84.8 score on a scale Standard Deviation 11.1	80.6 score on a scale Standard Deviation 18.7	77.4 score on a scale Standard Deviation 23.9

PRIMARY outcome

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Population: Participants ran with each of three feet: prescribed, CAESAR, and AllPro

Participants will run on a treadmill with force sensors below the treadmill belt. Data will be measured in Newtons and then normalized by dividing by body weight.

Outcome measures

Measure	Prescribed n=3 Participants This is a commercial prosthetic foot that has been prescribed to the individual	AllPro n=2 Participants This is a commercially available prosthetic foot designed for high-activity individuals	CAESAR n=3 Participants Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running	0.093 Body-weights Standard Deviation 0.006178	0.079 Body-weights Standard Deviation 0.005169	.154 Body-weights Standard Deviation 0.004942

PRIMARY outcome

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Population: Participants who ran in the lab with each foot style. One participant did not complete the survey with his prescribed foot

Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)

Outcome measures

Measure	Prescribed n=4 Participants This is a commercial prosthetic foot that has been prescribed to the individual	AllPro n=5 Participants This is a commercially available prosthetic foot designed for high-activity individuals	CAESAR n=5 Participants Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Participants Perceived Comfort When Using Different Prosthetic Feet During Running	51.8 score on a scale Standard Deviation 27.2	59.6 score on a scale Standard Deviation 23.3	66.4 score on a scale Standard Deviation 36.5

SECONDARY outcome

Timeframe: All conditions were complete during 3 lab visits, approximately four hours long

Population: Participants who could run comfortably on the treadmill for 5 minutes with that foot

Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace

Outcome measures

Measure	Prescribed n=3 Participants This is a commercial prosthetic foot that has been prescribed to the individual	AllPro n=2 Participants This is a commercially available prosthetic foot designed for high-activity individuals	CAESAR n=3 Participants Compliant Adaptive Energy Storage and Return Foot: The primary concept of the CAESAR foot is to switch from a walking foot to a running foot with the push of a button
Net V02 (Metabolic Cost) During Running	25.66 mL/kg/min Standard Deviation 2.93	26.86 mL/kg/min Standard Deviation 2.99	27.68 mL/kg/min Standard Deviation 2.52

Adverse Events

Prosthetic Foot Intervention

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

Dr. Deanna Gates

University of Michigan

Phone: 7346472698

Email: gatesd@umich.edu

Results disclosure agreements

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