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

Not Applicable

Completed

• Conditions: Artificial Limb; Amputation
• Interventions: Device: Crossover foot; Device: Energy Storing Foot

• Registration Number: NCT04086641
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-09-09
• Study First Posted: 2019-09-11
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Results First Submitted: 2020-10-19
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-17
• Last Update Submitted: 2020-11-17
• Results First Posted: 2020-12-14
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot	Crossover foot	Participant randomized to crossover foot as first condition, energy storing foot as second condition
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot	Crossover foot	Participant randomized to energy storing foot as first condition, crossover foot as second condition
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot	Energy Storing Foot	Participant randomized to energy storing foot as first condition, crossover foot as second condition
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot	Energy Storing Foot	Participant randomized to crossover foot as first condition, energy storing foot as second condition

Primary Outcome Measures

Name	Time	Method
Ratio Between Sound and Prosthetic Side Step Lengths	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.
Total Prosthetic Ankle Range of Motion	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
Prosthetic-side Energy Return	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
Peak Sound-side Limb Loading	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

Name	Time	Method
Preference Questionnaire	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?").
Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2	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.
Change in Activities-Specific Balance Confidence Scale (ABC)	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.
Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction	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)

Trial Locations

Locations (1)

University of Washington, Amplifying Mobility and Performance Laboratory; 🇺🇸 Seattle, Washington, United States