N/A N=10 Treatment

Comparative Performance of Dynamic Elastic Response Feet

Transtibial Amputation - Unilateral

Bottom Line

View on ClinicalTrials.gov: NCT02542761 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Peak Ankle Dorsiflexion During Stance — 18.871; 22.023; 18.657; 22.016 degrees

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fiberglass Composite foot (Device); Carbon Fiber Composite Foot (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Peak Ankle Dorsiflexion During Stance	18.871; 22.023; 18.657; 22.016; 17.09; 19.98	—
SECONDARY Peak Ankle Plantar Flexor Moment During Stance	1.3446; 1.4451; 1.3732; 1.4418; 1.0989; 1.1662	—
SECONDARY Peak Ankle Power Generation	1.130; 1.605; 1.080; 1.475; 0.979; 1.292	—
SECONDARY Peak Knee Flexion During Swing	69.61; 71.52; 67.38; 70.08; 72.42; 73.57	—
SECONDARY Time of Peak Knee Flexion During Swing	71.841; 72.077; 72.132; 72.293; 67.794; 67.194	—
SECONDARY Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)	79.64; 84.74; 77.89; 85.83; 78.25; 83.00	—

Summary

The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite.

Eligibility Criteria

Inclusion Criteria

Unilateral transtibial amputee
Currently using a carbon fiber prosthetic (DER) foot for at least the last 6 months
Stable stump volume over the past 6 months
Medicare Functional Classification Level K3 or K4

Exclusion Criteria

Neuromuscular problems such as previous stroke or contralateral amputation
Use of gait aids for ambulation
Undergoing dialysis
Poor prosthetic socket fit or stump problems (e.g., skin breakdown)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02542761). 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.