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

November 17, 2020 updated by: Sara Morgan, University of Washington

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington, Amplifying Mobility and Performance Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Participant randomized to crossover foot as first condition, energy storing foot as second condition
Device: Crossover foot
A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.
Device: Energy Storing Foot
A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.
Experimental: Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
Participant randomized to energy storing foot as first condition, crossover foot as second condition
Device: Crossover foot
A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.
Device: Energy Storing Foot
A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
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
Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
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
Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)
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
Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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?").
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)
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.
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)
Self-reported measure of balance confidence, the ABC is a single measure, scores range from 0-4, higher scores represent better balance confidence.
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)
Self-reported measures of aesthetic prosthetic satisfaction, scores on items are averaged and range from 0-2, higher values represent more satisfaction (better outcome)
Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Morgan, PhD, CPO, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 3, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00007788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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