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Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

NCT06214026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-05-23

No results posted yet for this 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

  • Amputation

Interventions

DEVICE

META-Arc foot locked

Participants are provided with the META-Arc from WIllowWood Global, and a locking mechanism prevents side-to-side motion.

DEVICE

META-Arc foot unlocked

Participants are provided with the META-Arc from WIllowWood Global allowing side-to-side motion.

Sponsors & Collaborators

Principal Investigators

  • Murray Maitland, PT, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-09-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214026 on ClinicalTrials.gov