Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

NCT06214026 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY00017239OP220033
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 10-Meter Walk Test

  Forward walking for 10 meters at a self-selected speed.

  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

  The Timed Up and Go Test starts with participant sitting in a chair. On the command "go," the individual will get up and walk 3 meters, turn 180 degrees to walk back the way they came, return to the chair, and sit down. There is one practice and one test.

  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

  For the Figure-of-8 Walk Test the participant will walk at their own pace three times in a figure-of-8 pattern around two cones placed 5 feet apart. They will have the opportunity to practice, and then the test will be repeated three times.

  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)

  The Four-square Step Test (FSST) involves stepping sideways, backwards, and forward following a pattern.

  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™)

  The PLUS-M 12-item questionnaire examines typical everyday mobility activities on a 5-point Likert scale.

  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).

Secondary Outcomes (4)

• Spatiotemporal parameters of gait

  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).

• Spatiotemporal parameters of gait

  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).

• Spatiotemporal parameters of gait

  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).

• Daily Activity Logbook: Balance Confidence

  Average of daily logbook across the 2-week trial of each investigational foot condition.

Study Arms (2)

Locked ankle articulation

EXPERIMENTAL

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.

Device: META-Arc foot locked

Unlocked ankle articulation

EXPERIMENTAL

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.

Device: META-Arc foot unlocked

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.

Locked ankle articulation

META-Arc foot unlocked DEVICE

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

Unlocked ankle articulation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Washington: lead
• United States Department of Defense: collaborator

Study Sites (3)

University of South Florida

Tampa, Florida, 333620, United States

RECRUITING

WillowWood Global

Mount Sterling, Ohio, 43143, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Study Officials

• Murray Maitland, PT, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Smersh

CONTACT

206-543-6995; msmersh@u.washington.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Associate: Department of Rehabilitation Medicine

Model Details: A1, B1, B2, A2 crossover design

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: January 19, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

US (3)