Functional Assessment of High-profile Crossover Feet in People With Syme's Amputation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Ratio Between Sound and Prosthetic Side Step Lengths
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Participant randomized to crossover foot as first condition, energy storing foot as second condition
Intervention: Crossover foot (Device)
Foot 1: Crossover Foot, Foot 2: Energy Storing Foot
Participant randomized to crossover foot as first condition, energy storing foot as second condition
Intervention: Energy Storing Foot (Device)
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
Participant randomized to energy storing foot as first condition, crossover foot as second condition
Intervention: Crossover foot (Device)
Foot 1: Energy Storing Foot, Foot 2: Crossover Foot
Participant randomized to energy storing foot as first condition, crossover foot as second condition
Intervention: Energy Storing Foot (Device)
Outcomes
Primary Outcomes
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.
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
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
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
Secondary Outcomes
- Preference Questionnaire(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(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)(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(Sessions 3 (after 2 weeks of prosthesis 1 wear) and 4 (after 2 weeks of prosthesis 2 wear))
Investigators
Sara Morgan
Assistant Professor
University of Washington