Limb Health and Socket Pressure in Response to Powered Ankle Prostheses
S
Sashwati Roy
Primary Investigator
Administratively Closed
18 years - 100 years
All
Phase
N/A
2 Locations
Brief description of study
The study involves participants with transtibial amputations, offering for a potential increase performance in mobility and quality of life. The study hopes to find that the impact on the muscle and skeletal systems improve with the use of the PROPRIO Foot of the Empower Ankle. Subjects will participate in 6 study visits which consist of various questionnaires related to the devices, assessments of fit and the use of the device itself as well as physical tasks while using either foot A or foot B. Each subject will receive foot A or foot B, but will be randomized to the order in which they receive them. Each device will be worn for 4 weeks.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: amputation,prosthetic
-
Age: 18 years - 100 years
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Gender: All
1.1 Inclusion Criteria
· Ages 18 and above
· Weight ≤ 280 lb
· Ambulate at a K3 level or higher-level determined from patient EHR
· At least 3 months post-amputation per physician discretion
· Residual limb length greater than 4.5 inches
· Use of a passive prosthesis
· Unilateral transtibial amputees
· Must be able to ambulate without any assistive devices
· Subjects must be able to follow directions and give informed consent on their own
Updated on
13 Nov 2025.
Study ID: SURG-IIR-OPORP, 12143, TX11394
