No Power Bionic Lower Extremity Prosthesis

Amputation Clinical Trial

Official title:

No Power Bionic Lower Extremity Prosthesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04070105
• Other study ID #: HUM00150407
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Amputation, Traumatic
• Amputation; Traumatic, Leg, Lower

Intervention

Device:
• 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
• AllPro
Participants will be fit with a high activity foot designed to be used for walking and running

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking	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.	All conditions were complete during 3 lab visits, approximately four hours long
Primary	Participants Perceived Comfort When Using Different Prosthetic Feet During Walking	Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)	All conditions were complete during 3 lab visits, approximately four hours long
Primary	Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running	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.	All conditions were complete during 3 lab visits, approximately four hours long
Primary	Participants Perceived Comfort When Using Different Prosthetic Feet During Running	Participants were asked their perceived comfort on a visual analog scale from 0 (most uncomfortable) to 100 (most comfortable)	All conditions were complete during 3 lab visits, approximately four hours long
Secondary	Net V02 (Metabolic Cost) During Running	Participants will wear a mask that measures their rate of oxygen consumption while they run for 5 minutes at a comfortable pace	All conditions were complete during 3 lab visits, approximately four hours long