Evaluating a new adaptable foot prosthesis for amputees

The Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis for People With Above-Knee Amputations, Bilateral Amputations, or Limited Mobility

This study is testing a new foot prosthesis that can adjust to different movements to see if it helps people with lower limb amputations walk better and feel more comfortable compared to their usual prosthetic feet.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: University of Washington (other)
• Locations: 3 sites (Tampa, Florida and 2 other locations)
• Trial ID: NCT06214026 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a novel foot prosthesis designed with frontal plane adaptability for individuals with lower extremity amputations. Participants will be randomly assigned to use either a locked or unlocked version of the prosthesis, allowing researchers to assess its impact on mobility, comfort, and daily activities. The study aims to compare the performance of this new prosthesis against participants' usual prosthetic feet over a series of visits. The trial will include individuals with above-knee and bilateral amputations, focusing on improving their functional mobility and quality of life.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 and older with above-knee or bilateral lower extremity amputations who can walk more than 400 meters without increased pain.

Not a fit: Patients with fluctuating conditions affecting gait mechanics or those unable to use a prosthesis due to skin wounds will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mobility and quality of life for amputees using advanced prosthetic technology.

How similar studies have performed: Previous studies have shown promise in improving prosthetic design and functionality, but this specific approach is relatively novel.

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.

Where this trial is running

Tampa, Florida and 2 other locations

• University of South Florida — Tampa, Florida, United States (RECRUITING)
• WillowWood Global — Mount Sterling, Ohio, United States (RECRUITING)
• University of Washington — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Murray Maitland, PT, PhD — University of Washington
• Study coordinator: Monica Smersh

Conditions: Amputation, prosthesis, foot prosthesis, Above-knee amputation, Bilateral lower extremity amputation, mobility disability