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

Amputation Clinical Trial

Official title:

Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086641
• Other study ID #: STUDY00007788
• Status: Completed
• Phase: N/A
• Start date: July 22, 2019
• Est. completion date: December 3, 2019

Study information

• Verified date: November 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Amputation
• Artificial Limb

Intervention

Device:
• Crossover foot
A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.
• Energy Storing Foot
A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.

Locations

Country	Name	City	State
United States	University of Washington, Amplifying Mobility and Performance Laboratory	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio Between Sound and Prosthetic Side Step Lengths	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)
Primary	Total Prosthetic Ankle Range of Motion	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)
Primary	Prosthetic-side Energy Return	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)
Primary	Peak Sound-side Limb Loading	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	Preference Questionnaire	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)
Secondary	Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2	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)
Secondary	Change in Activities-Specific Balance Confidence Scale (ABC)	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)
Secondary	Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction	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)