Recruiting

Prosthetic Foot

Sponsor:

Seattle Institute for Biomedical and Clinical Research

Code:

NCT05473065

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Multiaxial Prosthetic Foot Emulator

Commercially available prosthetic feet

Study Details

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

Study ID

NCT05473065

Start date

Mar 1, 2024

Status verified date

Sep, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Multiaxial Prosthetic Foot Emulator (PFE)

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.

active comparator: Commercially available prosthetic feet

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

Interventions

Multiaxial Prosthetic Foot Emulator

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.

Commercially available prosthetic feet

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.

Primary outcome measure

  • Self-report: perceived stability [ Time Frame: Administered at baseline and during follow up testing with the commercial feet (approximately 2 hours) ]
  • Biomechanical measures: Medial/Lateral Margin of Stability (MOS) [ Time Frame: Administered during follow up testing with the commercial feet (approximately 2 hours) ]
  • Performance-based outcomes: Narrowing Beam Walking Test [ Time Frame: Administered at baseline with the commercial feet (approximately 2 hours) ]
  • Performance-based outcomes: Narrowing Beam Walking Test [ Time Frame: Administered during follow up testing with the commercial feet (approximately 2 hours) ]
  • Performance-based outcomes: Four Square Step Test [ Time Frame: Administered at baseline with the commercial feet (approximately 2 hours) ]
  • Performance-based outcomes: Four Square Step Test [ Time Frame: Administered during follow up testing with the commercial feet (approximately 2 hours) ]
  • Self-report: balance confidence Activities-specific Balance Confidence [ Time Frame: Administered at baseline with the commercial feet (approximately 2 hours) ]
  • Self-report: Activity Restriction PROMIS Ability to Participate in Social Roles and Activities (APSRA) [ Time Frame: Administered at baseline with the commercial feet (approximately 2 hours) ]
  • Self-report: Activity Restriction PROMIS Ability to Participate in Social Roles and Activities (APSRA) [ Time Frame: Administered during follow up testing with the commercial feet (approximately 2 hours) ]
  • Self-report: perceived stability with emulated feet and commercial feet [ Time Frame: 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 [ Time Frame: Administered during initial testing with emulated feet (approximately two hours) ]
  • Self-report: perceived stability with emulated feet and balance confidence using corresponding commercial feet [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Administered at follow up using the actual prosthetic feet (approximately two hours) ]
  • Self-report: initial perceived stability and follow-up perceived stability [ Time Frame: Administered during initial testing with the actual feet (approximately two hours) ]
  • Self-report: initial perceived stability and follow-up perceived stability [ Time Frame: 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 [ Time Frame: Administered during initial testing with actual feet (approximately two hours) ]
  • Self-report: initial perceived stability and follow-up performance-based based measures of stability [ Time Frame: Administered at follow up using the actual prosthetic feet (approximately two hours) ]

Central Contacts and Locations

Central contacts

David C Morgenroth, MD

206-277-1982dmorgen@uw.edu

Elizabeth G Halsne, PhD, CPO

206-277-1217bhalsne@uw.edu

Locations

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

David C Morgenroth, MD

206-277-1982dmorgen@uw.edu

More Information

Sponsor

Seattle Institute for Biomedical and Clinical Research

Last update posted

Sep 8, 2025

Last verified

Sep, 2025

Keywords

  • amputation
  • rehabilitation
  • balance
  • stability
  • falls
  • emulator
  • prosthetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research on 2025-09-08.