AmputationNCT05473065
A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
A study testing Multiaxial Prosthetic Foot Emulator and Commercially available prosthetic feet in people with Amputation, run by Seattle Institute for Biomedical and Clinical Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Amputation
- What is being tested?
- Multiaxial Prosthetic Foot Emulator and Commercially available prosthetic feet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: A Prosthetic Foot Test-Drive Strategy for Improving Stability and Falls-Related Outcomes in Veterans With Leg Amputations
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.
Read the detailed description
Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and people with limb loss suffer from a wide range of mobility limitations including balance and stability impairments. Selecting an optimal prosthetic foot is an important aspect of maximizing mobility, limiting falls, and the achievement of functional goals for people with lower leg amputation (LLA), however there is limited evidence to guide this process. The current prosthetic prescription process relies on clinician experience and typically does not allow people with a leg amputation to easily try out different prosthetic feet. The investigators have developed a customizable robotic prosthetic foot that can mimic the mechanical properties of commercially available prosthetic feet in the coronal and sagittal planes without physically changing feet. This multiaxial 'prosthetic foot emulator' (PFE) can be attached to the prescribed prosthetic socket and worn like a regular prosthetic foot within the laboratory or clinic, providing people with LLA the opportunity to quickly 'test-drive' many prosthetic foot designs within a single test session. Trial and error with actual commercial prosthetic feet can be inefficient given the time and expense required for the purchasing and fitting of prosthetic feet. The PFE could provide a means to explore a range of feet over uneven, incline, and cross sloped surfaces in a very short period of time. This study aims to optimize stability and balance-related outcomes, to minimize falls, and to optimize vocational and avocational participation and functional quality for life for Veterans with LLA. This study will determine the effects of coronal and sagittal plane commercially-available prosthetic foot stiffness on stability and falls related outcomes and will evaluate the use of a test-drive strategy using a PFE to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. Results from this study may contribute to increased understanding of how a patient-centered strategy for optimizing prosthetic prescription can improve patient satisfaction, functional outcomes, and balance confidence for Veterans and others with LLA.
- Conditions
- Amputation
- Being tested
- Multiaxial Prosthetic Foot Emulator, Commercially available prosthetic feet
- Keywords
- amputation, rehabilitation, balance, stability, falls, emulator, prosthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiaxial Prosthetic Foot EmulatorDevice
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 feetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Multiaxial Prosthetic Foot Emulator |
| Commercially available prosthetic feet | Active comparator | Participants will walk under different walking conditions using three different commercial prosthetic feet. Receives: Device: Commercially available prosthetic feet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Administered at follow up using the actual prosthetic feet (approximately two hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Mar 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Minneapolis Veterans Affairs Medical Center, University of Chicago
- Responsible party
- Sponsor
- Investigators
- David C Morgenroth, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473065
- Sponsor's protocol ID
- W81XWH-20-1-0291
- Other IDs
- MD15, CDMRP-OP190048
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 41124130
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prosthetic Foot Test-Drive Strategy for Improving Stability and Falls-Related Outcomes in Veterans With Leg Amputations
- ClinicalTrials.gov ID
- NCT05473065
- Acronym / sponsor ID
- W81XWH-20-1-0291
- Conditions
- Amputation
- Keywords
- amputation, rehabilitation, balance, stability, falls, emulator, prosthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seattle Institute for Biomedical and Clinical ResearchUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, Minneapolis Veterans Affairs Medical Center, University of Chicago
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and people with limb loss suffer from a wide range of mobility limitations including balance and stability impairments. Selecting an optimal prosthetic foot is an important aspect of maximizing mobility, limiting falls, and the achievement of functional goals for people with lower leg amputation (LLA), however there is limited evidence to guide this process. The current prosthetic prescription process relies on clinician experience and typically does not allow people with a leg amputation to easily try out different prosthetic feet. The investigators have developed a customizable robotic prosthetic foot that can mimic the mechanical properties of commercially available prosthetic feet in the coronal and sagittal planes without physically changing feet. This multiaxial 'prosthetic foot emulator' (PFE) can be attached to the prescribed prosthetic socket and worn like a regular prosthetic foot within the laboratory or clinic, providing people with LLA the opportunity to quickly 'test-drive' many prosthetic foot designs within a single test session. Trial and error with actual commercial prosthetic feet can be inefficient given the time and expense required for the purchasing and fitting of prosthetic feet. The PFE could provide a means to explore a range of feet over uneven, incline, and cross sloped surfaces in a very short period of time. This study aims to optimize stability and balance-related outcomes, to minimize falls, and to optimize vocational and avocational participation and functional quality for life for Veterans with LLA. This study will determine the effects of coronal and sagittal plane commercially-available prosthetic foot stiffness on stability and falls related outcomes and will evaluate the use of a test-drive strategy using a PFE to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. Results from this study may contribute to increased understanding of how a patient-centered strategy for optimizing prosthetic prescription can improve patient satisfaction, functional outcomes, and balance confidence for Veterans and others with LLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiaxial Prosthetic Foot Emulator (PFE) | Experimental | Device: Multiaxial Prosthetic Foot EmulatorThe 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. |
| Commercially available prosthetic feet | Active comparator | Device: Commercially available prosthetic feetParticipants will walk under different walking conditions using three different commercial prosthetic feet. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiaxial Prosthetic Foot EmulatorParticipants 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. | Device | Multiaxial Prosthetic Foot Emulator (PFE) |
| Commercially available prosthetic feetParticipants 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. | Device | Commercially available prosthetic feet |
Primary outcome
Self-report: perceived stability
Time frame: Administered at baseline and during follow up testing with the commercial feet (approximately 2 hours)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and perceived stability during walking on uneven ground and cross-slopes
Biomechanical measures: Medial/Lateral Margin of Stability (MOS)
Time frame: Administered during follow up testing with the commercial feet (approximately 2 hours)
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
Performance-based outcomes: Narrowing Beam Walking Test
Time frame: Administered at baseline with the commercial feet (approximately 2 hours)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Narrowing Beam Walking Test score.
Performance-based outcomes: Narrowing Beam Walking Test
Time frame: Administered during follow up testing with the commercial feet (approximately 2 hours)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Narrowing Beam Walking Test score.
Performance-based outcomes: Four Square Step Test
Time frame: Administered at baseline with the commercial feet (approximately 2 hours)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Four Square Step Test score.
Performance-based outcomes: Four Square Step Test
Time frame: Administered during follow up testing with the commercial feet (approximately 2 hours)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Four Square Step Test score.
Self-report: balance confidence Activities-specific Balance Confidence
Time frame: Administered at baseline with the commercial feet (approximately 2 hours)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and Activities-specific Balance Confidence (ABC) score
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)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and PROMIS Ability to Participate in Social Roles and Activities (APSRA)
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)
Correlation between prosthetic foot sagittal and coronal plane stiffness properties and PROMIS Ability to Participate in Social Roles and Activities (APSRA)
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)
Correlation between participants self-report perceived stability using the multiaxial prosthetic foot emulator and the commercial prosthetic study feet
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)
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
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)
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
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)
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
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)
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
Self-report: initial perceived stability and follow-up perceived stability
Time frame: Administered during initial testing with the actual feet (approximately two hours)
Correlation between initial perceived stability with each actual foot (relative to other feet) and perceived stability with the corresponding foot at follow-up
Self-report: initial perceived stability and follow-up perceived stability
Time frame: Administered at follow up using the actual prosthetic feet (approximately two hours)
Correlation between initial perceived stability with each actual foot (relative to other feet) and perceived stability with the corresponding foot at follow-up
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)
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 41124130Ho 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Morgenroth, MD principal investigator
VA Puget Sound Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiaxial Prosthetic Foot Emulator and Commercially available prosthetic feet in people with Amputation, run by Seattle Institute for Biomedical and Clinical Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report: perceived stability (time frame: Administered at baseline and during follow up testing with the commercial feet (approximately 2 hours)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05473065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.