- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04086641
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
5
Phase
- 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
-
-
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
Ages Eligible for Study
16 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 |
Intervention / Treatment |
---|---|
Experimental: Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Participant randomized to crossover foot as first condition, energy storing foot as second condition
|
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.
|
Experimental: Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
Participant randomized to energy storing foot as first condition, crossover foot as second condition
|
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.
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
July 22, 2019
Primary Completion (Actual)
December 3, 2019
Study Completion (Actual)
December 3, 2019
Study Registration Dates
First Submitted
August 16, 2019
First Submitted That Met QC Criteria
September 9, 2019
First Posted (Actual)
September 11, 2019
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
November 17, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID 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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