NCT04070105

No Power Bionic Lower Extremity Prosthesis

Completed NA Results posted Last updated 27 March 2024

What this trial tests

NA trial testing Compliant Adaptive Energy Storage and Return Foot in Amputation in 6 participants. Completed in 31 December 2022.

Timeline

1 September 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	1 September 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Compliant Adaptive Energy Storage and Return Foot
• AllPro

Conditions studied

• Amputation — all drugs for Amputation →
• Amputation, Traumatic — all drugs for Amputation, Traumatic →
• Amputation; Traumatic, Leg, Lower — all drugs for Amputation; Traumatic, Leg, Lower →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Amputation or Amputation, Traumatic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking Primary · All conditions were complete during 3 lab visits, approximately four hours long

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.

Group	Value	95% CI
Prescribed	.175	± 0.043
AllPro	.166	± 0.022
CAESAR	.166	± 0.013

Participants Perceived Comfort When Using Different Prosthetic Feet During Walking Primary · 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)

Group	Value	95% CI
Prescribed	84.8	± 11.1
AllPro	80.6	± 18.7
CAESAR	77.4	± 23.9

Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running Primary · All conditions were complete during 3 lab visits, approximately four hours long

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.

Group	Value	95% CI
Prescribed	0.093	± 0.006178
AllPro	0.079	± 0.005169
CAESAR	.154	± 0.004942

Net V02 (Metabolic Cost) During Running Secondary · All conditions were complete during 3 lab visits, approximately four hours long

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

Group	Value	95% CI
Prescribed	25.66	± 2.93
AllPro	26.86	± 2.99
CAESAR	27.68	± 2.52

Participants Perceived Comfort When Using Different Prosthetic Feet During Running Primary · 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)

Group	Value	95% CI
Prescribed	51.8	± 27.2
AllPro	59.6	± 23.3
CAESAR	66.4	± 36.5

Sponsor's own description

Typically people need separate prosthetic feet for running and walking. To bridge the gap, this study will test the Compliant Adaptive Energy Storage and Return (CAESAR) foot. This foot can change from a walk mode to a run mode with the push of a button. The investigators will test and improve this foot design mechanically, and then test this design on individuals with lower limb amputation in a lab setting. The goal of this project is to develop a passive prosthetic foot that can serve two purposes in someone's daily life: walking and running, to allow them to be more active.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.