A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations

NCT05473065 | Recruiting FDA Device

• 3 other identifiers: W81XWH-20-1-0291MD15CDMRP-OP190048
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6.

Conditions

Amputation

Keywords

amputation; rehabilitation; balance; stability; falls; emulator; prosthetics

Outcome Measures

Primary Outcomes (18)

• Self-report: perceived stability

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and perceived stability during walking on uneven ground and cross-slopes

  Administered at baseline and during follow up testing with the commercial feet (approximately 2 hours)

• Biomechanical measures: Medial/Lateral Margin of Stability (MOS)

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Medial/Lateral Margin of Stability (MOS) during walking on uneven ground and cross-slopes

  Administered during follow up testing with the commercial feet (approximately 2 hours)

• Performance-based outcomes: Narrowing Beam Walking Test

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Narrowing Beam Walking Test score.

  Administered at baseline with the commercial feet (approximately 2 hours)

• Performance-based outcomes: Narrowing Beam Walking Test

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Narrowing Beam Walking Test score.

  Administered during follow up testing with the commercial feet (approximately 2 hours)

• Performance-based outcomes: Four Square Step Test

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Four Square Step Test score.

  Administered at baseline with the commercial feet (approximately 2 hours)

• Performance-based outcomes: Four Square Step Test

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Four Square Step Test score.

  Administered during follow up testing with the commercial feet (approximately 2 hours)

• Self-report: balance confidence Activities-specific Balance Confidence

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Activities-specific Balance Confidence (ABC) score

  Administered at baseline with the commercial feet (approximately 2 hours)

• Self-report: Activity Restriction PROMIS Ability to Participate in Social Roles and Activities (APSRA)

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and PROMIS Ability to Participate in Social Roles and Activities (APSRA)

  Administered at baseline with the commercial feet (approximately 2 hours)

• Self-report: Activity Restriction PROMIS Ability to Participate in Social Roles and Activities (APSRA)

  Correlation between prosthetic foot sagittal and coronal plane stiffness properties and PROMIS Ability to Participate in Social Roles and Activities (APSRA)

  Administered during follow up testing with the commercial feet (approximately 2 hours)

• Self-report: perceived stability with emulated feet and commercial feet

  Correlation between participants self-report perceived stability using the multiaxial prosthetic foot emulator and the commercial prosthetic study feet

  Administered during initial testing with emulated and actual prosthetic feet (approximately two hours)

• Self-report: perceived stability with emulated feet and balance confidence using corresponding commercial feet

  Correlation between participants self-report perceived stability using the multiaxial prosthetic foot emulator during initial testing and their balance confidence using the Activities-specific Balance Confidence during follow up with the corresponding commercial prosthetic foot

  Administered during initial testing with emulated feet (approximately two hours)

• Self-report: perceived stability with emulated feet and balance confidence using corresponding commercial feet

  Correlation between participants self-report perceived stability using the multiaxial prosthetic foot emulator during initial testing and their balance confidence using the Activities-specific Balance Confidence during follow up with the corresponding commercial prosthetic foot

  Administered at follow up using the actual prosthetic feet (approximately two hours)

• Self-report: perceived stability with emulated feet and performance-based measures of stability (NBWT and FSST) using corresponding commercial feet

  Correlation between participants self-report perceived stability using the multiaxial prosthetic foot emulator during initial testing and their performance-based stability using the Narrowing Beam Walking Test (NBWT) and Four Square Step Test (FSST) during follow up with the corresponding commercial prosthetic foot

  Administered during initial testing with emulated feet (approximately two hours)

• Self-report: perceived stability with emulated feet and performance-based measures of stability (NBWT and FSST) using corresponding commercial feet

  Correlation between participants self-report perceived stability using the multiaxial prosthetic foot emulator during initial testing and their performance-based stability using the Narrowing Beam Walking Test (NBWT) and Four Square Step Test (FSST) during follow up with the corresponding commercial prosthetic foot

  Administered at follow up using the actual prosthetic feet (approximately two hours)

• Self-report: initial perceived stability and follow-up perceived stability

  Correlation between initial perceived stability with each actual foot (relative to other feet) and perceived stability with the corresponding foot at follow-up

  Administered during initial testing with the actual feet (approximately two hours)

• Self-report: initial perceived stability and follow-up perceived stability

  Correlation between initial perceived stability with each actual foot (relative to other feet) and perceived stability with the corresponding foot at follow-up

  Administered at follow up using the actual prosthetic feet (approximately two hours)

• Self-report: initial perceived stability and follow-up performance-based based measures of stability

  Correlation between initial perceived stability with each actual foot (relative to other feet) and performance-based stability using the Narrowing Beam Walking Test (NBWT) and Four Square Step Test (FSST) during follow up with the corresponding commercial prosthetic foot

  Administered during initial testing with actual feet (approximately two hours)

• Self-report: initial perceived stability and follow-up performance-based based measures of stability

  Correlation between initial perceived stability with each actual foot (relative to other feet) and performance-based stability using the Narrowing Beam Walking Test (NBWT) and Four Square Step Test (FSST) during follow up with the corresponding commercial prosthetic foot

  Administered at follow up using the actual prosthetic feet (approximately two hours)

Study Arms (2)

Multiaxial Prosthetic Foot Emulator (PFE)

EXPERIMENTAL

The multiaxial Prosthetic Foot Emulator (PFE) is a customizable robotic prosthetic foot that can mimic commercial feet to predict how prosthesis users will respond to candidate feet. Participants will walk with the PFE using three different modes (emulating three commercial feet) under different walking conditions.

Device: Multiaxial Prosthetic Foot Emulator

Commercially available prosthetic feet

ACTIVE COMPARATOR

Participants will walk under different walking conditions using three different commercial prosthetic feet.

Device: Commercially available prosthetic feet

Interventions

Multiaxial Prosthetic Foot Emulator DEVICE

Participants will walk in the laboratory with the multiaxial Prosthetic Foot Emulator (PFE) in three foot modes corresponding to commercial prosthetic study feet. Walking conditions will include self-selected comfortable, slow, and fast speeds, inclines, cross slopes, and uneven terrain.

Multiaxial Prosthetic Foot Emulator (PFE)

Commercially available prosthetic feet DEVICE

Participants will walk in the laboratory with the commercial prosthetic study feet in three foot modes corresponding to commercial prosthetic study feet. Walking conditions will include self-selected comfortable, slow, and fast speeds, inclines, cross slopes, and uneven terrain. Additionally, participants will be fit with one of the commercial prosthetic study feet and wear it at home and in the community for approximately one week. Participants will return to the laboratory to follow-up testing, and will complete the community trial with each of the three commercial prosthetic study feet.

Commercially available prosthetic feet

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has a unilateral (one leg) transtibial (below-knee) amputation
• has used a prosthetic limb for walking for at least six months
• has a comfortably fitting prosthetic socket
• has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet
• be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials

You may not qualify if:

• contralateral limb or upper limb amputation that would interfere with completion of study activities
• are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet)
• unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress
• current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness)
• weight greater than 263lbs.
• inadequate cognitive or language function to consent to participate
• currently incarcerated
• impaired decision-making ability or the use of a legally authorized representative

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• VA Puget Sound Health Care System: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• University of Chicago: collaborator

Study Sites (2)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

NOT YET RECRUITING

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

Related Publications (1)

• Ho TK, Halsne EG, Koehler-McNicholas SR, Hansen AH, Sawers A, Caputo JM, Curran CS, Lloyd A, Cave J, Morgenroth DC. Assessing the effects of prosthetic foot stiffness and foot preference on stability, balance confidence, and satisfaction in transtibial prosthesis users: Protocol for a randomized, participant-masked crossover trial using a 'test-drive' strategy. PLoS One. 2025 Oct 22;20(10):e0334497. doi: 10.1371/journal.pone.0334497. eCollection 2025.

  PMID: 41124130 DERIVED

Study Officials

• David C Morgenroth, MD

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David C Morgenroth, MD

CONTACT

206-277-1982; dmorgen@uw.edu

Elizabeth G Halsne, PhD, CPO

CONTACT

206-277-1217; bhalsne@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the commercial prosthetic foot type and to the emulated foot condition
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 25, 2022
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (2)