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

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ClinicalTrials.gov Identifier: NCT04086641
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Morgan, University of Washington

Brief 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 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.

Condition or disease Intervention/treatment Phase
Amputation Artificial Limb Device: Crossover foot Device: Energy Storing Foot Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Crossover foot
Prosthetic foot that attaches to the proximal posterior socket. Relatively long strut length.
Device: Crossover foot
A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.

Active Comparator: Energy Storing Foot
Prosthetic foot that attaches to the distal aspect of the socket. Relatively short strut length.
Device: Energy Storing Foot
A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.




Primary Outcome Measures :
  1. Change in step length asymmetry [ Time Frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) ]
    The difference between prosthetic and sound side step lengths

  2. Change in 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 total angular motion of the ankle in the sagittal plane during stance phase

  3. Change in 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. Change in 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 Outcome Measures :
  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 Functional 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 functional prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)

  5. 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)

  6. Change in Trinity Amputation and Prosthesis Experience Scales- Revised Activity Restrictions [ Time Frame: Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear) ]
    Self-reported measures of activity restrictions, scores on items are averaged and range from 0-2, higher values represent more activity restrictions (worse outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04086641


Contacts
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Contact: Sara Morgan, PhD, CPO 206-616-9997 sjmorgan@uw.edu
Contact: Conrad Slater, BS 540-931-8478 cs4qc@uw.edu

Locations
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United States, Washington
University of Washington, Amplifying Mobility and Performance Laboratory Recruiting
Seattle, Washington, United States, 98195
Contact: Sara Morgan, PhD, CPO    206-616-9997    sjmorgan@uw.edu   
Principal Investigator: Sara Morgan, PhD, CPO         
Sub-Investigator: Brian Hafner, PhD         
Sub-Investigator: Conrad Slater, BS         
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Sara Morgan, PhD, CPO University of Washington

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Responsible Party: Sara Morgan, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT04086641     History of Changes
Other Study ID Numbers: STUDY00007788
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Morgan, University of Washington:
Ankle disarticulation
Syme
Amputation
Prosthesis
Prosthetic foot
Crossover foot
Biomechanics