Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of Washington
Study ID
NCT06214026
Status
Recruiting
Apply to this trial

Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • META-Arc foot locked — DEVICE
    Participants are provided with the META-Arc from WIllowWood Global, and a locking mechanism prevents side-to-side motion.
  • META-Arc foot unlocked — DEVICE
    Participants are provided with the META-Arc from WIllowWood Global allowing side-to-side motion.

Study Details

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 Dates

Start date
Sep 1, 2023
Status verified
May 2024
Primary completion
Sep 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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). ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of South FloridaTampaFlorida333620
Stephanie Carey, PhD
[email protected]
813-974-5765
WillowWood GlobalMount SterlingOhio43143
Alex Arbury, CPO
[email protected]
740-869-3377
Jim Colvin
[email protected]
740-869-3377
University of WashingtonSeattleWashington98195
Monica Smersh
[email protected]
425-331-9737
Murray Maitland, PhD
[email protected]
4252865278

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By research site
University of South Florida· Tampa, FLWillowWood Global· Mount Sterling, OHUniversity of Washington· Seattle, WA

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