AmputationNCT03651830
A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
A study testing Prosthetic Foot Emulator and Commercially available prosthetic feet in people with Amputation, run by Seattle Institute for Biomedical and Clinical Research at 3 sites in United States.
Trial summary
Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (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?
- 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
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Sep 2018to 14 Jun 2022
- 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
- be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials
- be age 18 to 89 years
Who cannot join
- contralateral limb or upper limb amputation
- are unable to use 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
- currently pregnant (determined via self-report during screening)
- current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness, lower extremity joint replacement)
- weight greater than 250lbs.
- inadequate cognitive or language function to consent to participate
- currently incarcerated
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
Center for the Intrepid
San Antonio, Texas, 78234
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: A Prosthetic Foot Emulator to Optimize Prescription of Prosthetic Feet in Veterans and Service Members With Leg Amputations
Objective/Hypotheses and Specific Aims: The primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet.
Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). 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 in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 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 two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 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. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE foot conditions to the respective actual prosthetic feet during walking. Additionally, a subset of participants may also be invited to participate in follow-up data collection comparing prosthetic foot conditions of different stiffness categories.
Read the detailed description
Objectives and Rationale: Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and a sub-optimal prosthesis can substantially restrict participation in desired activities. Selecting an optimal prosthetic foot is an important aspect of maximizing mobility and the achievement of functional goals for people with lower leg amputation, 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 mimics the mechanical properties of commercially available prosthetic feet without physically changing feet. This '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 leg amputations 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 in a very short period of time. This study will evaluate the ability of the emulator to accurately reproduce the experience of wearing several commercially available (actual) prosthetic feet. The investigators will test whether brief in-laboratory experiences with emulated or actual feet can accurately predict longer-term foot preference, satisfaction, and walking ability in the community. The investigators will also evaluate the experiences of prosthetic foot prescription practices using qualitative methods from follow-up phone interviews with participants. Finally, the investigators will evaluate biomechanical outcomes during walking between the PFE and actual prosthetic feet to examine the ability of the emulator to accurately reproduce the experience of walking with the actual feet. Results from this study may provide evidence to support a new approach to prosthesis prescription and could resolve longstanding uncertainty in the prescription process for prosthetic feet.
- Conditions
- Amputation
- Being tested
- Prosthetic Foot Emulator, Commercially available prosthetic feet
- Keywords
- Amputation, Rehabilitation, Prescriptions, Emulator, Prosthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic Foot EmulatorDevice
Participants will walk in the laboratory with the Prosthetic Foot Emulator (PFE) in three foot modes corresponding to actual study feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs.
Commercially available prosthetic feetDevice
Participants will walk in the laboratory with three different commercially available prosthetic feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs.
Additionally, participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. This will be followed by two-week periods in the community with each of the other two commercially available prosthetic feet.
| Study group | Role | What they receive |
|---|---|---|
| Prosthetic Foot Emulator | Experimental | The Prosthetic Foot Emulator (PFE) is a customizable robotic prosthetic foot that can mimic commercial feet to predict how individual patients 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: 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.
Foot Preference Survey
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Measured: Administered during initial testing with prosthetic foot emulator (approximately 2 hours).
Foot Preference Survey
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Measured: Administered during initial testing with actual prosthetic feet (approximately 2 hours).
Foot Preference Survey
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Measured: Administered at 2-week follow up for prosthetic foot A.
Foot Preference Survey
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Measured: Administered at 2-week follow up for prosthetic foot B.
Foot Preference Survey
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Measured: Administered at 2-week follow up for prosthetic foot C.
Secondary outcomes (9)
Two Minute Walk Test
Participants are asked to walk for 2 minutes at their fastest possible speed and distance walked is recorded.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Prosthetic Limb Users Survey of Mobility (PLUS-M), tailored short-form
Standardized self-report item bank.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Activities Specific Balance Confidence Scale (ABC)
This is a subjective measure of confidence in performing ambulatory activities without falling or feeling unsteady. The investigators are using a revised version of the ABC recommended to ease administration and improve scoring. Questions answered on 0-4 scale (0 = No Confidence; 4 = Complete Confidence). Scores for 16 questions combined and averaged.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Trinity Amputation and Prosthesis Experience Scales (TAPES)
Multidimensional health instrument that measures self-reported activity restrictions (TAPES-AR) and satisfaction with the function (TAPES-FUN) of a prosthesis. Other subscales of TAPES will not be used. Questions answered on 0-2 scale (0 = No, not limited; 2 = Yes, limited a lot for TAPES-AR, and 0= Not satisfied; 2 = Very satisfied for TAPES-FUN). Subscales will be scored separately. For TAPES-AR, scores of all items answered will be combined and averaged. For TAPES-FUN, scores for all items will be added together.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Four Square Step Test (FSST)
Participants are asked to step over canes in a specific sequence as quickly as possible and two trials are timed and recorded.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Timed Up and Go (TUG)
Participants are asked to start at sitting, stand and walk around a cone, and return to a seated position. Two trials are performed at both a comfortable pace and at a fast pace. All trials are timed and times are recorded.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Narrowing Beam Walking Test (NBWT)
Participants are asked to walk as far as possible along a narrowing beam without using arms or assistance for balance. Five trails are completed and distances are recorded.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Berg Balance Scale (BBS)
Participants are asked to perform a variety of tasks such as sitting, standing, turning, and transferring between chairs, in order to measure balance.
Measured: Administered at baseline and at 2-week follow up for each foot condition.
Kinematic and kinetic outcome analysis
Some participants are asked to complete biomechanical gait analysis while walking with the PFE and the corresponding actual prosthetic feet while wearing reflective markers in a motion capture laboratory (Vicon motion capture system). Ankle, knee, hip, trunk, and upper body motion data will be collected while participants walk at self-selected speeds on an instrumented treadmill. These kinematic and kinetic outcome data will be collected at follow-up study visits up to 100 weeks after enrollment and after participants complete previous study activities (note: only a subset of participants).
Measured: up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start24 Sep 2018
- Primary completion20 May 2021
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 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, Brooke Army Medical Center, Stanford University, University of Washington
- Responsible party
- Sponsor
- Investigators
- David Morgenroth, MD, Principal investigator, VA Puget Sound Health Care System and SIBCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651830
- Sponsor's protocol ID
- MD13
- Other IDs
- W81XWH-16-1-056
- Status last verified
- Feb 2024
- First submitted
- 15 Aug 2018
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prosthetic Foot Emulator to Optimize Prescription of Prosthetic Feet in Veterans and Service Members With Leg Amputations
- ClinicalTrials.gov ID
- NCT03651830
- Acronym / sponsor ID
- MD13
- Conditions
- Amputation
- Keywords
- Amputation, Rehabilitation, Prescriptions, Emulator, Prosthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 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, Brooke Army Medical Center, Stanford University, University of Washington
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 29 Aug 2018 (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 primary aim of this proposal is to determine whether a PFE can be used to predict foot preference and mobility outcomes with corresponding commercial prosthetic feet in people with a unilateral transtibial amputation (TTA). Secondarily, the investigators aim to determine whether a brief trial of commercial prosthetic feet would be able to similarly predict longer-term foot preference and mobility outcomes with those feet.
Study Design: The investigators will use a participant blinded cross-over study with repeated measurements. Participants with TTA will be enrolled at each of the three study sites: two VA sites (Puget Sound and Minneapolis), and one Department of Defense site (Center for the Intrepid). 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 in the laboratory. During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if Day 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 two weeks. At visit 4 participants will be fit with the next actual foot and repeat the 2 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. Participants' preference, satisfaction and perceived mobility, and functional mobility will be measured and compared across all foot conditions (emulated and actual). After participants complete the procedures detailed above, they may be eligible to be invited to participate in follow-up phone interviews. A subset of participants may also be invited to participate in follow-up biomechanical data collection comparing the PFE foot conditions to the respective actual prosthetic feet during walking. Additionally, a subset of participants may also be invited to participate in follow-up data collection comparing prosthetic foot conditions of different stiffness categories.
Detailed description
Objectives and Rationale: Using a prosthesis allows many who experience lower leg amputation to regain functional abilities, but walking may be more difficult, and a sub-optimal prosthesis can substantially restrict participation in desired activities. Selecting an optimal prosthetic foot is an important aspect of maximizing mobility and the achievement of functional goals for people with lower leg amputation, 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 mimics the mechanical properties of commercially available prosthetic feet without physically changing feet. This '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 leg amputations 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 in a very short period of time. This study will evaluate the ability of the emulator to accurately reproduce the experience of wearing several commercially available (actual) prosthetic feet. The investigators will test whether brief in-laboratory experiences with emulated or actual feet can accurately predict longer-term foot preference, satisfaction, and walking ability in the community. The investigators will also evaluate the experiences of prosthetic foot prescription practices using qualitative methods from follow-up phone interviews with participants. Finally, the investigators will evaluate biomechanical outcomes during walking between the PFE and actual prosthetic feet to examine the ability of the emulator to accurately reproduce the experience of walking with the actual feet. Results from this study may provide evidence to support a new approach to prosthesis prescription and could resolve longstanding uncertainty in the prescription process for prosthetic feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prosthetic Foot Emulator | Experimental | Device: Prosthetic Foot EmulatorThe Prosthetic Foot Emulator (PFE) is a customizable robotic prosthetic foot that can mimic commercial feet to predict how individual patients 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
- be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials
- be age 18 to 89 years
Key exclusion criteria (8 listed)
- contralateral limb or upper limb amputation
- are unable to use 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
- currently pregnant (determined via self-report during screening)
- current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness, lower extremity joint replacement)
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 |
|---|---|---|
| Prosthetic Foot EmulatorParticipants will walk in the laboratory with the Prosthetic Foot Emulator (PFE) in three foot modes corresponding to actual study feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs. | Device | Prosthetic Foot Emulator |
| Commercially available prosthetic feetParticipants will walk in the laboratory with three different commercially available prosthetic feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs. Additionally, participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. This will be followed by two-week periods in the community with each of the other two commercially available prosthetic feet. | Device | Commercially available prosthetic feet |
Primary outcome
Foot Preference Survey
Time frame: Administered during initial testing with prosthetic foot emulator (approximately 2 hours).
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Foot Preference Survey
Time frame: Administered during initial testing with actual prosthetic feet (approximately 2 hours).
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Foot Preference Survey
Time frame: Administered at 2-week follow up for prosthetic foot A.
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Foot Preference Survey
Time frame: Administered at 2-week follow up for prosthetic foot B.
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
Foot Preference Survey
Time frame: Administered at 2-week follow up for prosthetic foot C.
Self-report survey related to prosthetic foot preference, satisfaction, and perceived mobility, with questions answered on 0-10 scale.
9 secondary outcomes
Two Minute Walk Test
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Prosthetic Limb Users Survey of Mobility (PLUS-M), tailored short-form
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Activities Specific Balance Confidence Scale (ABC)
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Trinity Amputation and Prosthesis Experience Scales (TAPES)
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Four Square Step Test (FSST)
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Timed Up and Go (TUG)
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Narrowing Beam Walking Test (NBWT)
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Berg Balance Scale (BBS)
Time frame: Administered at baseline and at 2-week follow up for each foot condition.
Kinematic and kinetic outcome analysis
Time frame: up to 100 weeks
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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 Morgenroth, MD principal investigator
VA Puget Sound Health Care System and SIBCR
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic Foot Emulator and Commercially available prosthetic feet in people with Amputation, run by Seattle Institute for Biomedical and Clinical Research at 3 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Foot Preference Survey (time frame: Administered during initial testing with prosthetic foot emulator (approximately 2 hours).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.