N/A
N=5
Comparison of Prosthetic Feet for People With Syme's Amputation (XF Symes Study)
Amputation · Artificial Limb
Bottom Line
View on ClinicalTrials.gov: NCT04086641 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Ratio Between Sound and Prosthetic Side Step Lengths — 0.88; 0.87; 1.02; 0.91 Sound step length / Pros. step length
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Crossover foot (Device); Energy Storing Foot (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio Between Sound and Prosthetic Side Step Lengths |
0.88; 0.87; 1.02; 0.91; 0.93; 0.91 | — |
| PRIMARY Total Prosthetic Ankle Range of Motion |
14.04; 14.20; 7.94; 9.03; 17.91; 16.24 | — |
| PRIMARY Prosthetic-side Energy Return |
0.86; 1.27; 0.32; 0.36; 2.18; 2.32 | — |
| PRIMARY Peak Sound-side Limb Loading |
1.06; 1.04; 1.06; 1.16; 1.07; 1.17 | — |
| SECONDARY Preference Questionnaire |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Change in Prosthetic Limb Users Survey of Mobility (PLUS-M) 12-item Short Form Version 1.2 |
64.5; 71.4; 64.5; 62.5 | — |
| SECONDARY Change in Activities-Specific Balance Confidence Scale (ABC) |
3.53; 4; 3.63; 4 | — |
| SECONDARY Change in Trinity Amputation and Prosthesis Experience Scales- Revised Aesthetic Satisfaction |
0.33; 2; 1; 1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04086641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.