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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06214026
The ClinicalTrials.gov registry entry for NCT06214026 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131-participant average among 65 other Amputation trials with a reported enrollment target (27% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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