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Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

The Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis for People With Above-Knee Amputations, Bilateral Amputations, or Limited Mobility

Who can join

Ages 16 and older · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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.

About the study

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 in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility.

The main study questions/goals are:

1a) To determine if frontal plane adaptation in a foot prosthesis impacts performance, comfort, activities of daily living, and community mobility in the study populations. To answer this question, we will compare a locked and unlocked version of the novel prosthesis.

1b) To determine how the unlocked investigational foot condition compares to the person's usual foot using the outcomes listed above.

2\) To examine the participants' lived experience during community activities. The study will use performance tests, questionnaires, logbooks, and interviews to monitor person-centered outcomes and perceptions of personal functioning during the use of the investigational foot (locked and unlocked) compared to the person's usual foot.

What is being tested

• META-Arc foot locked (device)
• META-Arc foot unlocked (device)

Sponsor: University of Washington · Participants: 96 · Started: Sep 1, 2023

Contact the study team

• Monica Smersh · Phone: 206-543-6995

Official record on ClinicalTrials.gov — NCT06214026

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.