AmputationNCT04086641
Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)
A study testing Crossover foot and Energy Storing Foot in people with Amputation and Artificial Limb, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Artificial Limb
- What is being tested?
- Crossover foot and Energy Storing Foot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have a unilateral Syme's amputation that occurred >1 year prior
- Owns a crossover foot modified for Syme's use
- Able to walk in the community without assistance
- Able to read and write in English
Who cannot join
- Have other amputations
- Have a health condition that would limit completion of the study protocol (e.g., skin breakdown, heart disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Amplifying Mobility and Performance Laboratory
Seattle, Washington, 98195
About this study
Official title: Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation
The purpose of this study is to compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the prosthetic socket, rather than the distal end. The hypothesis is that the high-profile foot (i.e., the crossover foot) will lead to functional and biomechanical improvements compared to low-profile feet.
Read the detailed description
Syme's prostheses are typically limited to low-profile prosthetic feet due to clearance restrictions below the prosthetic socket. As a result, the functional benefits provided by the long residual limb are mitigated by prosthetic design limitations. Recently, high-profile, posteriorly-attaching crossover feet have been modified for use with people who have Syme's amputation. Crossover feet theoretically improve motion and energy storage-and-return compared to traditional foot options for the Syme's level. Crossover feet also have the potential to broaden the range of high-impact activities that can be performed with a single prosthesis. However, to date there is no empirical evidence that compares functional differences when walking with high-profile crossover feet compared to low-profile feet for people with Syme's amputation. This mixed-method pilot research will use a randomized, controlled within-participants design. Investigators will assess gait biomechanics, self-reported health outcomes, and qualitative interviews to compare relative advantages and disadvantages of traditional low-profile Syme's feet and high-profile crossover feet. This proposed work will create a foundation for future research that examines the potential benefits of crossover feet in people with Syme's amputation. In addition, results from this research will be used clinically to inform prosthetic options for people with limited clearance for distally-attached prosthetic feet.
- Conditions
- Amputation, Artificial Limb
- Being tested
- Crossover foot, Energy Storing Foot
- Keywords
- Ankle disarticulation, Syme, Amputation, Prosthesis, Prosthetic foot, Crossover foot, Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crossover footDevice
A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.
Energy Storing FootDevice
A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.
| Study group | Role | What they receive |
|---|---|---|
| Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Experimental | Participant randomized to crossover foot as first condition, energy storing foot as second condition Receives: Device: Crossover foot; Device: Energy Storing Foot |
| Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Experimental | Participant randomized to energy storing foot as first condition, crossover foot as second condition Receives: Device: Crossover foot; Device: Energy Storing Foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio Between Sound and Prosthetic Side Step Lengths
The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot.
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Total Prosthetic Ankle Range of Motion
The change in total angular motion of the ankle in the sagittal plane (e.g., dorsiflexion \& plantarflexion) during stance phase between prosthetic feet, in degrees
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Prosthetic-side Energy Return
Intersegmental flow of power out of the prosthesis
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Peak Sound-side Limb Loading
Maximum vertical ground reaction force in early stance
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Secondary outcomes (4)
Preference Questionnaire
At the end of the study, participants will engage in a preference questionnaire with open-ended follow-up questions to elicit preferences and experiences with both feet. Questions will ask about overall preference, and preference for a range of mobility activities (e.g., "Which foot did you prefer overall, and why?" and "Which foot did you prefer for walking up stairs, and why?").
Measured: Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2)
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2
Self-reported measure of mobility, the PLUS-M 12-item Short Form is a single measure, scores range from 17.5-76.6, higher scores represent better mobility.
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Change in Activities-Specific Balance Confidence Scale (ABC)
Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence.
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction
Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)
Measured: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start22 Jul 2019
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Morgan, University of Washington
- Investigators
- Sara Morgan, PhD, CPO, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086641
- Sponsor's protocol ID
- STUDY00007788
- Status last verified
- Nov 2020
- First submitted
- 16 Aug 2019
- Last updated
- 14 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slater C, Hafner BJ, Morgan SJ. Effects of high-profile crossover feet on gait biomechanics in 2 individuals with Syme amputation. Prosthet Orthot Int. 2024 Oct 1;48(5):510-518. doi: 10.1097/PXR.0000000000000295. Epub 2023 Oct 20.
PubMed 37870369
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation
- ClinicalTrials.gov ID
- NCT04086641
- Acronym / sponsor ID
- STUDY00007788
- Conditions
- Amputation, Artificial Limb
- Keywords
- Ankle disarticulation, Syme, Amputation, Prosthesis, Prosthetic foot, Crossover foot, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Posted 14 Dec 2020
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 compare the functional differences between two types of foot prostheses for people with ankle disarticulation (Syme's) amputations. The two feet being tested are low- and high-profile feet, with the difference being the latter has an extended keel and attaches to the posterior of the prosthetic socket, rather than the distal end. The hypothesis is that the high-profile foot (i.e., the crossover foot) will lead to functional and biomechanical improvements compared to low-profile feet.
Detailed description
Syme's prostheses are typically limited to low-profile prosthetic feet due to clearance restrictions below the prosthetic socket. As a result, the functional benefits provided by the long residual limb are mitigated by prosthetic design limitations. Recently, high-profile, posteriorly-attaching crossover feet have been modified for use with people who have Syme's amputation. Crossover feet theoretically improve motion and energy storage-and-return compared to traditional foot options for the Syme's level. Crossover feet also have the potential to broaden the range of high-impact activities that can be performed with a single prosthesis. However, to date there is no empirical evidence that compares functional differences when walking with high-profile crossover feet compared to low-profile feet for people with Syme's amputation. This mixed-method pilot research will use a randomized, controlled within-participants design. Investigators will assess gait biomechanics, self-reported health outcomes, and qualitative interviews to compare relative advantages and disadvantages of traditional low-profile Syme's feet and high-profile crossover feet. This proposed work will create a foundation for future research that examines the potential benefits of crossover feet in people with Syme's amputation. In addition, results from this research will be used clinically to inform prosthetic options for people with limited clearance for distally-attached prosthetic feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Experimental | Device: Crossover foot, Device: Energy Storing FootParticipant randomized to crossover foot as first condition, energy storing foot as second condition |
| Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Experimental | Device: Crossover foot, Device: Energy Storing FootParticipant randomized to energy storing foot as first condition, crossover foot as second condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Have a unilateral Syme's amputation that occurred >1 year prior
- Owns a crossover foot modified for Syme's use
- Able to walk in the community without assistance
- Able to read and write in English
Key exclusion criteria (2 listed)
- Have other amputations
- Have a health condition that would limit completion of the study protocol (e.g., skin breakdown, heart disease)
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 |
|---|---|---|
| Crossover footA prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket. | Device | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot, Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
| Energy Storing FootA prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket. | Device | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot, Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
Primary outcome
Ratio Between Sound and Prosthetic Side Step Lengths
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
The symmetry between prosthetic and sound side step lengths. Step lengths were calculated as the distance between heels from heel strike of the contralateral foot to heel strike of the ipsilateral foot.
Total Prosthetic Ankle Range of Motion
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
The change in total angular motion of the ankle in the sagittal plane (e.g., dorsiflexion \& plantarflexion) during stance phase between prosthetic feet, in degrees
Prosthetic-side Energy Return
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Intersegmental flow of power out of the prosthesis
Peak Sound-side Limb Loading
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Maximum vertical ground reaction force in early stance
4 secondary outcomes
Preference Questionnaire
Time frame: Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2)
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Change in Activities-Specific Balance Confidence Scale (ABC)
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37870369Slater C, Hafner BJ, Morgan SJ. Effects of high-profile crossover feet on gait biomechanics in 2 individuals with Syme amputation. Prosthet Orthot Int. 2024 Oct 1;48(5):510-518. doi: 10.1097/PXR.0000000000000295. Epub 2023 Oct 20.
- 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.
Sara Morgan, PhD, CPO principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crossover foot and Energy Storing Foot in people with Amputation and Artificial Limb, run by University of Washington 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 5 inclusion and 2 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 14 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ratio Between Sound and Prosthetic Side Step Lengths (time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)). The study lists 4 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 NCT04086641, 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 14 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.