NCT06214026 Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis
| NCT ID | NCT06214026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2023-09-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Murray Maitland, PT, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06214026 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06214026 currently recruiting?
Yes, NCT06214026 is actively recruiting participants. Contact the research team at msmersh@u.washington.edu for enrollment information.
Where is the NCT06214026 trial being conducted?
This trial is being conducted at Tampa, United States, Mount Sterling, United States, Seattle, United States.
Who is sponsoring the NCT06214026 clinical trial?
NCT06214026 is sponsored by University of Washington. The principal investigator is Murray Maitland, PT, PhD at University of Washington. The trial plans to enroll 96 participants.