An interventional study of Crossover foot and Energy Storing Foot in Amputation and Artificial Limb, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-14.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Participant randomized to crossover foot as first condition, energy storing foot as second condition
Device: Crossover foot · Device: Energy Storing Foot
Participant randomized to energy storing foot as first condition, crossover foot as second condition
Device: Crossover foot · Device: Energy Storing Foot
A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.
A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
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?").
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
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.
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)
Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence.
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
Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)
Time frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
| Milestone | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Started | 2 | 3 |
| Completed | 1 | 1 |
| Not completed | 1 | 2 |
| Withdrew: Covid-19 | 1 | 2 |
| Milestone | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
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.
| Sound step length / Pros. step length | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot, Slow Walking Speed | 0.88 | 0.87 |
| Energy Storing Foot, Slow Walking Speed | 1.02 | 0.91 |
| Crossover Foot, Comfortable Walking Speed | 0.93 | 0.91 |
| Energy Storing Foot, Comfortable Walking Speed | 0.96 | 0.92 |
| Crossover Foot, Fast Walking Speed | 0.93 | 0.94 |
| Energy Storing Foot, Fast Walking Speed | 0.97 | 0.97 |
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
| degrees | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot, Slow Walking Speed | 14.04 | 14.20 |
| Energy Storing Foot, Slow Walking Speed | 7.94 | 9.03 |
| Crossover Foot, Comfortable Walking Speed | 17.91 | 16.24 |
| Energy Storing Foot, Comfortable Walking Speed | 11.17 | 9.63 |
| Crossover Foot, Fast Walking Speed | 16.74 | 17.53 |
| Energy Storing Foot, Fast Walking Speed | 11.91 | 11.20 |
Intersegmental flow of power out of the prosthesis
| W/kg | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot, Slow Walking Speed | 0.86 | 1.27 |
| Energy Storing Foot, Slow Walking Speed | 0.32 | 0.36 |
| Crossover Foot, Comfortable Walking Speed | 2.18 | 2.32 |
| Energy Storing Foot, Comfortable Walking Speed | 0.90 | 0.53 |
| Crossover Foot, Fast Walking Speed | 2.82 | 4.22 |
| Energy Storing Foot, Fast Walking Speed | 1.53 | 0.75 |
Maximum vertical ground reaction force in early stance
| Ratio (Newtons/body weight) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot, Slow Walking Speed | 1.06 | 1.04 |
| Energy Storing Foot, Slow Walking Speed | 1.06 | 1.16 |
| Crossover Foot, Comfortable Walking Speed | 1.07 | 1.17 |
| Energy Storing Foot, Comfortable Walking Speed | 1.23 | 1.29 |
| Crossover Foot, Fast Walking Speed | 1.37 | 1.53 |
| Energy Storing Foot, Fast Walking Speed | 1.43 | 1.45 |
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?").
| Participants | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Walking on inclines — Prefers Crossover Foot | 1 | 1 |
| Walking on inclines — Prefers Energy Storing Foot | 0 | 0 |
| Walking on inclines — No preference | 0 | 0 |
| Walking on inclines — Not applicable | 0 | 0 |
| Walking on declines — Prefers Crossover Foot | 1 | 0 |
| Walking on declines — Prefers Energy Storing Foot | 0 | 0 |
| Walking on declines — No preference | 0 | 1 |
| Walking on declines — Not applicable | 0 | 0 |
| Ascending stairs — Prefers Crossover Foot | 1 | 1 |
| Ascending stairs — Prefers Energy Storing Foot | 0 | 0 |
| Ascending stairs — No preference | 0 | 0 |
| Ascending stairs — Not applicable | 0 | 0 |
| Descending stairs — Prefers Crossover Foot | 1 | 1 |
| Descending stairs — Prefers Energy Storing Foot | 0 | 0 |
| Descending stairs — No preference | 0 | 0 |
| Descending stairs — Not applicable | 0 | 0 |
| Walking slowly — Prefers Crossover Foot | 0 | 1 |
| Walking slowly — Prefers Energy Storing Foot | 0 | 0 |
| Walking slowly — No preference | 1 | 0 |
| Walking slowly — Not applicable | 0 | 0 |
| Walking quickly — Prefers Crossover Foot | 1 | 1 |
| Walking quickly — Prefers Energy Storing Foot | 0 | 0 |
| Walking quickly — No preference | 0 | 0 |
| Walking quickly — Not applicable | 0 | 0 |
| Running — Prefers Crossover Foot | 1 | 1 |
| Running — Prefers Energy Storing Foot | 0 | 0 |
| Running — No preference | 0 | 0 |
| Running — Not applicable | 0 | 0 |
| Walking over uneven terrain — Prefers Crossover Foot | 0 | 1 |
| Walking over uneven terrain — Prefers Energy Storing Foot | 0 | 0 |
| Walking over uneven terrain — No preference | 1 | 0 |
| Walking over uneven terrain — Not applicable | 0 | 0 |
| Standing up from a chair — Prefers Crossover Foot | 1 | 0 |
| Standing up from a chair — Prefers Energy Storing Foot | 0 | 0 |
| Standing up from a chair — No preference | 0 | 1 |
| Standing up from a chair — Not applicable | 0 | 0 |
| Sitting down in a chair — Prefers Crossover Foot | 0 | 0 |
| Sitting down in a chair — Prefers Energy Storing Foot | 0 | 0 |
| Sitting down in a chair — No preference | 1 | 1 |
| Sitting down in a chair — Not applicable | 0 | 0 |
| Turning on the prosthetic side — Prefers Crossover Foot | 1 | 1 |
| Turning on the prosthetic side — Prefers Energy Storing Foot | 0 | 0 |
| Turning on the prosthetic side — No preference | 0 | 0 |
| Turning on the prosthetic side — Not applicable | 0 | 0 |
| Getting in and out of a car — Prefers Crossover Foot | 0 | 1 |
| Getting in and out of a car — Prefers Energy Storing Foot | 0 | 0 |
| Getting in and out of a car — No preference | 1 | 0 |
| Getting in and out of a car — Not applicable | 0 | 0 |
| Playing sports — Prefers Crossover Foot | 1 | 1 |
| Playing sports — Prefers Energy Storing Foot | 0 | 0 |
| Playing sports — No preference | 0 | 0 |
| Playing sports — Not applicable | 0 | 0 |
| Standing for long periods — Prefers Crossover Foot | 0 | 1 |
| Standing for long periods — Prefers Energy Storing Foot | 0 | 0 |
| Standing for long periods — No preference | 1 | 0 |
| Standing for long periods — Not applicable | 0 | 0 |
| Walking in sand — Prefers Crossover Foot | 0 | 0 |
| Walking in sand — Prefers Energy Storing Foot | 0 | 1 |
| Walking in sand — No preference | 0 | 0 |
| Walking in sand — Not applicable | 1 | 0 |
| Walking when you can't see your feet — Prefers Crossover Foot | 0 | 1 |
| Walking when you can't see your feet — Prefers Energy Storing Foot | 0 | 0 |
| Walking when you can't see your feet — No preference | 1 | 0 |
| Walking when you can't see your feet — Not applicable | 0 | 0 |
| Walking when carrying a heavy load — Prefers Crossover Foot | 0 | 1 |
| Walking when carrying a heavy load — Prefers Energy Storing Foot | 0 | 0 |
| Walking when carrying a heavy load — No preference | 1 | 0 |
| Walking when carrying a heavy load — Not applicable | 0 | 0 |
| Walking in small spaces — Prefers Crossover Foot | 0 | 1 |
| Walking in small spaces — Prefers Energy Storing Foot | 0 | 0 |
| Walking in small spaces — No preference | 1 | 0 |
| Walking in small spaces — Not applicable | 0 | 0 |
| Dancing — Prefers Crossover Foot | 1 | 1 |
| Dancing — Prefers Energy Storing Foot | 0 | 0 |
| Dancing — No preference | 0 | 0 |
| Dancing — Not applicable | 0 | 0 |
| Riding a bicycle — Prefers Crossover Foot | 0 | 1 |
| Riding a bicycle — Prefers Energy Storing Foot | 0 | 0 |
| Riding a bicycle — No preference | 1 | 0 |
| Riding a bicycle — Not applicable | 0 | 0 |
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.
| score on a scale | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot | 64.5 | 71.4 |
| Energy Storing Foot | 64.5 | 62.5 |
Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence.
| score on a scale | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot | 3.53 | 4 |
| Energy Storing Foot | 3.63 | 4 |
Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)
| score on a scale | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot |
|---|---|---|
| Crossover Foot | 0.33 | 2 |
| Energy Storing Foot | 1 | 1 |
Collected over Through study completion, an average of 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| Mean | 51 | 34 | 42.5 ± 8.5 |
| Sex: Female, Male(Participants) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 1 | 2 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| United States | 0 | 1 | 1 |
| Canada | 1 | 0 | 1 |
| Amputation Etiology(Participants) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| Trauma | 1 | 0 | 1 |
| Cancer | 0 | 1 | 1 |
| MFCL(Participants) | Foot 1: Crossover Foot, Foot 2: Energy Storing Foot | Foot 1: Energy Storing Foot, Foot 2: Crossover Foot | Total |
|---|---|---|---|
| K4 | 1 | 1 | 2 |
| K1-3 | 0 | 0 | 0 |
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