Back to search results

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

This study is looking at a new type of prosthetic foot called the META-Arc from WillowWood Global for people who have had a lower limb amputation. The goal is to see if allowing the foot to move side-to-side (unlocked) helps with balance, walking, and daily activities more than when this movement is prevented (locked). You would try both the META-Arc foot with and without side-to-side motion, as well as your usual prosthetic foot. Researchers will measure how well you walk using tests like the 10-Meter Walk Test, Timed Up and Go Test, and Figure-of-8 Walk Test. This study aims to understand how different prosthetic foot designs can improve life for people with amputations. Participants must be at least 16 years old, live independently, and meet certain weight and foot size requirements. The study status is currently unclear.

Study design
This is a randomized cross-over clinical trial involving 96 participants. It compares a META-Arc foot with a locked mechanism to one with an unlocked mechanism, and also to a participant's usual prosthetic foot.
What's involved
You would have an initial visit for data collection and fitting. You would then try each investigational foot condition for two weeks, and return to your usual foot for two weeks in between.
Compensation
Not stated in the trial record.
Follow-up
Your walking ability will be measured after each two-week trial period with the investigational feet, and again after returning to your usual foot for two weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06214026

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

Recruiting
NAAges 16+InterventionalTreatment
University of Washington
~96 participants
Updated 2024-05-23 on ClinicalTrials.gov
What's tested:META-Arc foot lockedMETA-Arc foot unlocked

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
10-Meter Walk Test
Measured over After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2).
+4 more outcomes measured

Conditions

Amputation

Explore related trials

Amputation

NCT06214026

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of South Florida

    Tampa, Floridastudy coordinator listed

    Recruiting

  • University of Washington

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • WillowWood Global

    Mount Sterling, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Murray Maitland, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Monica Smersh
[email protected]
206-543-6995
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.

What this trial measures

  • 10-Meter Walk TestAfter 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2).

    Forward walking for 10 meters at a self-selected speed.

  • Timed Up and Go TestAfter 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2).

    The Timed Up and Go Test starts with participant sitting in a chair. On the command "go," the individual will get up and walk 3 meters, turn 180 degrees to walk back the way they came, return to the chair, and sit down. There is one practice and one test.

  • Figure-of-8 Walk TestAfter 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2).

    For the Figure-of-8 Walk Test the participant will walk at their own pace three times in a figure-of-8 pattern around two cones placed 5 feet apart. They will have the opportunity to practice, and then the test will be repeated three times.

  • The Four-square Step Test (FSST)After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2).

    The Four-square Step Test (FSST) involves stepping sideways, backwards, and forward following a pattern.

  • The Prosthetic Limb Users Survey of Mobility (PLUS-M™)After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2).

    The PLUS-M 12-item questionnaire examines typical everyday mobility activities on a 5-point Likert scale.