Recruiting

Prosthesis Comparison

Sponsor:

University of Washington

Code:

NCT06214026

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

META-Arc foot locked

META-Arc foot unlocked

Study Details

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.

Conditions

Amputation

Study ID

NCT06214026

Start date

Sep 1, 2023

Status verified date

May, 2024

Completion date

Apr, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

META-Arc foot locked

Participants are provided with the META-Arc from WIllowWood Global, and a locking mechanism prevents side-to-side motion.

META-Arc foot unlocked

Participants are provided with the META-Arc from WIllowWood Global allowing side-to-side motion.

Primary outcome measure

  • 10-Meter Walk Test [ Time Frame: After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2). ]
  • Timed Up and Go Test [ Time Frame: After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2). ]
  • Figure-of-8 Walk Test [ Time Frame: After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2). ]
  • The Four-square Step Test (FSST) [ Time Frame: After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2). ]
  • The Prosthetic Limb Users Survey of Mobility (PLUS-M™) [ Time Frame: After 2-week trial of investigational foot Condition 1 (B1), after 2-week trial of investigational foot Condition 2 (B2) after return to usual foot for 2 weeks (A2). ]

Central Contacts and Locations

Central contacts

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 333620

Contacts

Stephanie Carey, PhD

813-974-5765scarey3@usf.edu

WillowWood Global

Recruiting

Mount Sterling, Ohio, United States, 43143

Contacts

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

More Information

Sponsor

University of Washington

Last update posted

May 23, 2024

Last verified

May, 2024

Keywords

  • prosthesis
  • foot prosthesis
  • Above-knee amputation
  • Bilateral lower extremity amputation
  • mobility disability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-05-23.