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

NCT ID: NCT04086641

Last Updated: 2020-12-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2019-12-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amputation Artificial Limb

Keywords

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Ankle disarticulation Syme Amputation Prosthesis Prosthetic foot Crossover foot Biomechanics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Foot 1: Crossover Foot, Foot 2: Energy Storing Foot

Participant randomized to crossover foot as first condition, energy storing foot as second condition

Group Type EXPERIMENTAL

Crossover foot

Intervention Type DEVICE

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

Energy Storing Foot

Intervention Type DEVICE

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

Foot 1: Energy Storing Foot, Foot 2: Crossover Foot

Participant randomized to energy storing foot as first condition, crossover foot as second condition

Group Type EXPERIMENTAL

Crossover foot

Intervention Type DEVICE

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

Energy Storing Foot

Intervention Type DEVICE

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

Interventions

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Crossover foot

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

Intervention Type DEVICE

Energy Storing Foot

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Sara Morgan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara Morgan, PhD, CPO

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington, Amplifying Mobility and Performance Laboratory

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Slater C, Hafner BJ, Morgan SJ. Effects of high-profile crossover feet on gait biomechanics in 2 individuals with Syme amputation. Prosthet Orthot Int. 2024 Oct 1;48(5):510-518. doi: 10.1097/PXR.0000000000000295. Epub 2023 Oct 20.

Reference Type DERIVED
PMID: 37870369 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00007788

Identifier Type: -

Identifier Source: org_study_id