ClinicalTrials.gov identifier: NCT02440711
Purpose: The goal of this study is to evaluate endurance, walking performance, mobility and perceived exertion of transtibial prosthesis users (ie, study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized crossover study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.
Study type: Interventional
Study design: Safety/efficacy study, single group assessment, open label
Estimated enrollment: 30
Eligibility criteria: Both genders eligible; ages 18 years and older. Patients must have unilateral or bilateral transtibial amputation from non-dysvascular causes; must be K-3 or higher; must be a prosthesis user for at least 1 year; must be scheduled to receive a mRSF prosthesis; must be able and willing to participate in study protocol, including treadmill walking, overground walking, answering survey questions and able to read and write in English. The study excludes patients who have contralateral lower or upper limb involvement or have any health condition that would limit participation in the study procedure.
Study start date: May 2015
Estimated study completion date: August 2017
Estimated primary completion date: The final collection date for primary outcome measures will be August 2017.
Primary outcome measures: Metabolic oxygen consumption, 6-minute walk test and Borg rating of perceived exertion are tested after using each foot in their prosthesis for 1 month.
Secondary outcome measures: Prosthetic Limb Users Survey of Mobility; Patient-Reported Outcome Measurement Information System – Fatigue; Activities-Specific Balance Confidence Scale; and Trinity Amputation Prosthesis Experience Scales, Revised. All are evaluated after using each foot in the prosthesis for 1 month.
Sponsors and collaborators: University of Washington
Contact: Brian Hafner, PhD, 206-685-4048, bhafner@uw.edu; Cody McDonald, CPO, 206-221-6347, codym@uw.edu
Information acquired from: Brian Hafner, PhD, via clinicaltrials.gov
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