Prosthesis UserNCT03505983
Criteria for Advanced Prosthetic Foot Prescription
A study testing ESR Prosthetic Foot First, Articulating ESR Prosthetic Foot First and Powered Prosthetic Foot First in people with Prosthesis User and Amputation; Traumatic, Limb, Lower, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthesis User, Amputation; Traumatic, Limb, Lower
- What is being tested?
- ESR Prosthetic Foot First, Articulating ESR Prosthetic Foot First and Powered Prosthetic Foot First
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
- Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
- Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items
- Has a minimum clearance of 8 ¾ inches to accommodate all feet
Who cannot join
- Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
- Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
- Weighs more than 275 pounds, the maximum product weight load
- Is unable or unwilling to comply with all research visits
- Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
- Women who are pregnant or plan to become pregnant during study activities. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
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- Poorly fitting socket
- Vision loss that requires use of an assistive device for gait
- Upper Limb Amputation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA New York Harbor Healthcare System
New York, New York, 10010
About this study
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.
- Being tested
- ESR Prosthetic Foot First, Articulating ESR Prosthetic Foot First, Powered Prosthetic Foot First
- Keywords
- Prosthetic Limb Design, Prosthesis Fitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESR Prosthetic Foot FirstDevice
Subjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Articulating ESR Prosthetic Foot FirstDevice
Also called Odyssey (College Park), Elan (Endolite), MotionFoot (Fillauer), Proflex (Ossur)
Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Powered Prosthetic Foot FirstDevice
Also called emPOWER (Otto Bock)
Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
| Study group | Role | What they receive |
|---|---|---|
| Articulating ESR Prosthetic Foot First | Active comparator | Subjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities. Receives: Device: Articulating ESR Prosthetic Foot First |
| Powered Prosthetic Foot First | Active comparator | Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities. Receives: Device: Powered Prosthetic Foot First |
| ESR Prosthetic Foot First | Active comparator | Subject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use. Receives: Device: ESR Prosthetic Foot First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-min walk distance for each prosthetic foot type
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in TUG times for each prosthetic foot type
The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in 4SST times for each prosthetic foot type
The four-square step test is a higher order complex task assessing dynamic balance.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in AmpPRO for each prosthetic foot type
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Stair Assessment Index (SAI) for each prosthetic foot type
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Hill Assessment Index (HAI) for each prosthetic foot type
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Gait Evaluation for each prosthetic foot type
Biomechanical evaluation of gait.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Secondary outcomes (5)
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
The PEQ is a self-report Visual Analog Scale questionnaires for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Short Form (SF)-12 for each prosthetic foot type
The SF-12 is a questionnaire used to measure the relationship between physical and mental health functioning and the social determinants of health. It is a self-reported questionnaire, on a rating scale, called a Likert Scale. The participant taking this questionnaire will check one response box per question. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Age-specific mean difference score (difference score) is calculated and is the amount by which a person's score differs from their age group's mean score. By looking at difference scores, it is clear whether a person is more or less healthy than other persons in his or her comparison group.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in OPUS for each prosthetic foot type
OPUS is a set of self-report instruments that assess functional status, quality of life, and satisfaction with devices and services that can be used in an orthotics and prosthetics clinic. The OPUS Health Quality of Life Score is the sum of the scores for the 23 items (0 - 92). The OPUS lower extremity total score is the sum of the scores for the 20 items (0 - 80). OPUS Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50). A higher score indicates a better outcome for all measures.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Final Visit Guided Interview
Final Visit questionnaire to evaluate subjective preferences. This is a free response questionnaire, in which the participant can answer in open-ended format.
Measured: Administered one time at Final Visit, which will occur 7 weeks after enrollment.
Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type
The PEQ-A is a free response 2-question questionnaire, in which the participant is asked whether and how many times they had experienced a fall or near-fall in the previous week using the particular prosthetic foot.
Measured: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start7 Mar 2018
- Primary completion14 Sep 2023
- Study completion1 Sep 2026 (estimated)
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 Prosthesis UserStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed National Military Medical Center, James A. Haley Veterans Administration Hospital, VA Puget Sound Health Care System
- Responsible party
- Principal investigator, Jason Maikos, VA New York Harbor Healthcare System
- Investigators
- Jason Maikos, PhD, Principal investigator, Director, VISN 2 Gait and Motion Analysis Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505983
- Sponsor's protocol ID
- IRB #01603
- Other IDs
- CDMRP-OP150095
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2018
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maikos JT, Hendershot BD, Pruziner AL, Hyre MJ, Chomack JM, Phillips SL, Heckman JT, Sidiropoulos AN, Dearth CL, Nelson LM. Criteria for Advanced Prosthetic Foot Prescription: Rationale, Design, and Protocol for a Multisite, Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 4;12:e45612. doi: 10.2196/45612.
PubMed 37014672
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria for Advanced Prosthetic Foot Prescription
- ClinicalTrials.gov ID
- NCT03505983
- Acronym / sponsor ID
- IRB #01603
- Keywords
- Prosthetic Limb Design, Prosthesis Fitting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Collaborators
- Walter Reed National Military Medical Center, James A. Haley Veterans Administration Hospital, VA Puget Sound Health Care System
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Apr 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.
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Articulating ESR Prosthetic Foot First | Active comparator | Device: Articulating ESR Prosthetic Foot FirstSubjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities. |
| Powered Prosthetic Foot First | Active comparator | Device: Powered Prosthetic Foot FirstSubjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities. |
| ESR Prosthetic Foot First | Active comparator | Device: ESR Prosthetic Foot FirstSubject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
- Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
- Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items
- Has a minimum clearance of 8 ¾ inches to accommodate all feet
Key exclusion criteria (9 listed)
- Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
- Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
- Weighs more than 275 pounds, the maximum product weight load
- Is unable or unwilling to comply with all research visits
- Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
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 |
|---|---|---|
| ESR Prosthetic Foot FirstSubjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use. | Device | ESR Prosthetic Foot First |
| Articulating ESR Prosthetic Foot FirstAlso: Odyssey (College Park), Elan (Endolite), MotionFoot (Fillauer), Proflex (Ossur)Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use. | Device | Articulating ESR Prosthetic Foot First |
| Powered Prosthetic Foot FirstAlso: emPOWER (Otto Bock)Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use. | Device | Powered Prosthetic Foot First |
Primary outcome
Change in 6-min walk distance for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Change in TUG times for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down.
Change in 4SST times for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The four-square step test is a higher order complex task assessing dynamic balance.
Change in AmpPRO for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Change in Stair Assessment Index (SAI) for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.
Change in Hill Assessment Index (HAI) for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.
Change in Gait Evaluation for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Biomechanical evaluation of gait.
5 secondary outcomes
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Short Form (SF)-12 for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in OPUS for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Final Visit Guided Interview
Time frame: Administered one time at Final Visit, which will occur 7 weeks after enrollment.
Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type
Time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 37014672Maikos JT, Hendershot BD, Pruziner AL, Hyre MJ, Chomack JM, Phillips SL, Heckman JT, Sidiropoulos AN, Dearth CL, Nelson LM. Criteria for Advanced Prosthetic Foot Prescription: Rationale, Design, and Protocol for a Multisite, Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 4;12:e45612. doi: 10.2196/45612.
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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.
Jason Maikos, PhD principal investigator
Director, VISN 2 Gait and Motion Analysis Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESR Prosthetic Foot First, Articulating ESR Prosthetic Foot First and Powered Prosthetic Foot First in people with Prosthesis User and Amputation; Traumatic, Limb, Lower, run by VA New York Harbor Healthcare System at 1 site 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 4 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in 6-min walk distance for each prosthetic foot type (time frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment). The study lists 7 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 NCT03505983, 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 10 Mar 2026.