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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of South Florida
RECRUITING
Tampa
Ohio
WillowWood Global
RECRUITING
Mount Sterling
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
Monica Smersh
msmersh@u.washington.edu
206-543-6995
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2027-04
Participants
Target number of participants: 96
Treatments
Experimental: Locked ankle articulation
The design is a randomized cross-over clinical trial following an A1-B1-B2-A2 design. In the locked condition, the 20 degree of frontal plane ankle motion is eliminated by a physical lock. The A conditions will be with the usual foot. The B conditions are randomized to the locked and unlocked investigational foot.
Experimental: Unlocked ankle articulation
The design is a randomized cross-over clinical trial following an A1-B1-B2-A2 design. In the unlocked condition, the 20 degree of frontal plane ankle motion is enabled. The A conditions will be with the usual foot. The B conditions are randomized to the locked and unlocked investigational foot.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: University of Washington

This content was sourced from clinicaltrials.gov