Evaluating a new adaptable foot prosthesis for amputees

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: msmersh@u.washington.edu
• Phone: 206-543-6995

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding the impact of powered prosthetics on walking for transfemoral amputees

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• Evaluation of a new myoelectric prosthesis for transradial amputees

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• Hand prosthesis usability and performance evaluation for people with upper limb absence

  This study tests a new multi-articulating hand prosthesis to see if it performs better or differently than a participant’s own prosthesis.

  Recruiting Össur Iceland ehf · Dublin, Ohio · NCT07915700

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.