N/A
N=6
No Power Bionic Lower Extremity Prosthesis
Amputation · Amputation, Traumatic · Amputation; Traumatic, Leg, Lower
Bottom Line
View on ClinicalTrials.gov: NCT04070105 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking — .175; .166; .166 Body-weights
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Compliant Adaptive Energy Storage and Return Foot (Device); AllPro (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Propulsive Ground Reaction Force on the Prosthetic Side During Walking |
.175; .166; .166 | — |
| PRIMARY Participants Perceived Comfort When Using Different Prosthetic Feet During Walking |
84.8; 80.6; 77.4 | — |
| PRIMARY Peak Propulsive Ground Reaction Force on the Prosthetic Side During Running |
0.093; 0.079; .154 | — |
| PRIMARY Participants Perceived Comfort When Using Different Prosthetic Feet During Running |
51.8; 59.6; 66.4 | — |
| SECONDARY Net V02 (Metabolic Cost) During Running |
25.66; 26.86; 27.68 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04070105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.