Clinical trial NCT04070105: No Power Bionic Lower Extremity Prosthesis
Official title: No Power Bionic Lower Extremity Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Amputation, Traumatic
Amputation; Traumatic, Leg, Lower
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will walk with their standard prosthesis, a commercial high activity foot, and then the new design of CAESAR foot
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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. Here we will test this device to determine how it affects the user's mechanics during running and walking. Participants will come to a research laboratory for three test sessions where they will run and walk in their current foot, a commercial high-activity foot, and the prototype CAESAR foot.

Eligibility criteria: Patient Population:

Inclusion Criteria:

* At least 18 years old
* Transtibial amputation of one or both legs
* Classified as K3 or K4 on the Medicare Functional Classification Level
* Use of a well-fitting prosthetic socket and prosthetic foot for at least 6 months
* Able to walk and run without assistance

Exclusion Criteria:

* Significant injury to intact limb
* History of balance impairments or neurologic disorders
* Significant cardiovascular or respiratory disease

Primary outcomes:
measure: Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking
timeFrame: All conditions were complete during 3 lab visits, approximately four hours long
measure: Participants Perceived Comfort When Using Different Prosthetic Feet During Walking
timeFrame: All conditions were complete during 3 lab visits, approximately four hours long
measure: Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running
timeFrame: All conditions were complete during 3 lab visits, approximately four hours long
measure: Participants Perceived Comfort When Using Different Prosthetic Feet During Running
timeFrame: All conditions were complete during 3 lab visits, approximately four hours long
Secondary outcomes:
measure: Net V02 (Metabolic Cost) During Running
timeFrame: All conditions were complete during 3 lab visits, approximately four hours long
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: