Amputation Clinical Trial
Official title:
No Power Bionic Lower Extremity Prosthesis
Verified date | February 2024 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
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 |
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