Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

Recruiting now · Not applicable

Conditions studied: Amputation

In brief

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.

Key facts

Study ID

NCT06214026

Run by

University of Washington

People needed

96

Starts

2023-09-01

Expected to finish

2027-04-01

Last updated by the study team

2024-05-23

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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