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NCT06214026 · ClinicalTrials.gov registry record · NA
Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
A NA study of Amputation, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 96
- Enrollment target
- 3
- Study locations
NCT06214026: Recruiting NA study of Amputation, sponsored by University of Washington.
NCT06214026 is a NA study of Amputation that is actively recruiting participants, run by University of Washington. The registered enrollment target is 96 participants, below the 131-participant average among 65 other Amputation trials with a reported enrollment target (27% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06214026, a NA study of Amputation, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
- 3
- Study locations
Study 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 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.
Primary Outcome
Forward walking for 10 meters at a self-selected speed.
Conditions Studied
Interventions
- DEVICE META-Arc foot locked
- DEVICE META-Arc foot unlocked
Study Locations (3)
Florida
- University of South Florida - Tampa
Ohio
- WillowWood Global - Mount Sterling
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2027-04 |
| Phase | NA |
What NCT06214026 shows while recruiting
NCT06214026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 131-participant average among 65 other Amputation trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Amputation appearing as the primary indexed condition, and to 2 interventions - of which META-Arc foot locked is the first listed.
NCT06214026 reports a single indexed study location in Florida, Ohio, Washington.
Frequently Asked Questions
What is clinical trial NCT06214026 about?
NCT06214026 is a clinical study titled "Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis". 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 ...
What is the current status of trial NCT06214026?
This trial is currently recruiting. It is a NA study. The enrollment target is 96 participants. The study started on 2023-09-01. Estimated completion is 2027-04.
What conditions does trial NCT06214026 study?
This clinical trial studies the following conditions: Amputation.
What interventions are being tested in trial NCT06214026?
The interventions under investigation include: META-Arc foot locked (DEVICE), META-Arc foot unlocked (DEVICE).
Who is sponsoring clinical trial NCT06214026?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06214026 being conducted?
This trial has 3 study locations across Florida, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amputation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06214026's enrollment target sits among peer trials
96 12th of 65 higher than 54 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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