Skip to main content
OpenTrials
Completed

NCT Number: NCT04086641

Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amputation Artificial Limb

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington, Amplifying Mobility and Performance Laboratory

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Have other amputations
  • Have a health condition that would limit completion of the study protocol (e.g., skin breakdown, heart disease)

Treatment and study plan

Crossover foot

Device

A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.

Energy Storing Foot

Device

A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Preference Questionnaire

    Time frame: Session 4 (after 4 weeks of prosthesis wear, 2 weeks of prosthesis 1 and 2 weeks of prosthesis 2)

    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?").

  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)

    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.

  3. 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)

    Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence.

  4. 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)

    Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2019
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.