Status:
RECRUITING
Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
Lead Sponsor:
University of Washington
Collaborating Sponsors:
United States Department of Defense
Conditions:
Amputation
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
People with lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation...
Detailed Description
The study design is a randomized cross-over clinical trial design (B1 and B2 phases) comparing a carbon fiber foot that includes a functional, unlocked frontal plane adaptable linkage compared to the ...
Eligibility Criteria
Inclusion
- Participants will be 16-years or older, regardless of gender, race, or ethnicity.
- Potential participants should reside in the community or an independent living environment.
- The upper weight limit is 165.6 kg (365 lbs.).
- Prosthetic foot sizes 22 cm (approximate US Men's shoe size 5) up to 30 cm (13 US Men's).
- Ability to walk more than 400 m on level ground without an increase in pain.
- At least one year post-amputation and using a prosthesis
- People must have the ability to read, write, and comprehend English.
Exclusion
- Participants must not have conditions such as skin wounds that preclude the use of a prosthesis.
- People will be excluded if they have fluctuating conditions that may significantly alter gait mechanics during the \~10-week study. Examples include Parkinson's disease, alcoholism, brain tumor, and hereditary cerebellar ataxias.
- Participants may use a walking aid but should not primarily rely on wheelchair mobility.
- People will be discontinued from the study if they become unable to use a prosthesis. Examples include major surgery and trauma. However, because of the potential for fluctuations in prosthesis use with this population, short-term issues will not disqualify people from continued participation when they resume prosthetic use.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06214026
Start Date
September 1 2023
End Date
April 1 2027
Last Update
May 23 2024
Active Locations (3)
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1
University of South Florida
Tampa, Florida, United States, 333620
2
WillowWood Global
Mount Sterling, Ohio, United States, 43143
3
University of Washington
Seattle, Washington, United States, 98195