Comparison of Various Prosthetic Foot-Ankle Mechanisms
NCT05964855 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-01-13
Summary
In summary, subjects will be asked to wear a number of sensors and use different ankle-foot prostheses in place of their customary prosthesis. Data will be collected from the wearable sensors, VICON motion capture system, video cameras, and force sensors in the ground as they walk on level-ground, on a treadmill, and on stairs. The controller of any powered prosthesis will be electronically adjusted between trials or while the subject walks to determine how their gait changes in response to these changes. Trials will also be conducted with a standard passive prosthesis that would be prescribed for a person of similar height and weight.
Conditions
- Transtibial Amputation - Unilateral
Interventions
- DEVICE
-
MIT Variable Stiffness Prosthesis
Proprietary electronically-controlled prosthesis that can vary its effective stiffness.
- DEVICE
-
MIT Variable Equilibrium Angle Prosthesis
Proprietary manually-controlled prosthesis that can vary its effective ankle equilibrium angle.
- DEVICE
-
MIT Sliding Beam Passive Prosthesis
Proprietary fixed-stiffness passive foot-ankle prosthesis.
- DEVICE
-
Ossur Pro-flex XC
Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.
- DEVICE
-
Blatchford Elan Variable-Dampening Prosthesis
Commercially-available electronically-controlled prosthesis that can vary its effective dampening.
Sponsors & Collaborators
-
Massachusetts Institute of Technology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-28
- Primary Completion
- 2025-09-01
- Completion
- 2025-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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