protocolSection identificationModule nctId: NCT06352788, orgStudyIdInfo id: 202007224, briefTitle: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices, acronym: AFOSVA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Jason Wilken, class: OTHER, collaborators name: Mayo Clinic, collaborators name: Vanderbilt University Medical Center, collaborators name: Navy Medical Center San Diego, collaborators name: Minneapolis Veterans Affairs Medical Center, collaborators name: Johns Hopkins University, descriptionModule briefSummary: This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury., conditionsModule conditions: Foot Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Study participants, investigators, and outcome assessors will be blinded to the condition being tested and will only be introduced to each condition as A, B, or C. Only study coordinators, who will verify adherence with the study protocol (CDO configuration), will not be blinded., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), interventions name: Mono Carbon Fiber Custom Dynamic Orthosis (CDO), outcomesModule primaryOutcomes measure: PROMIS Physical Function, primaryOutcomes measure: PROMIS Pain Interference, primaryOutcomes measure: OPUS Satisfaction with Device and Services, primaryOutcomes measure: Modified Socket Comfort Score - Comfort, primaryOutcomes measure: Modified Socket Comfort Score - Smoothness, primaryOutcomes measure: Numerical Pain Rating Scale, primaryOutcomes measure: Preference - Ranked, primaryOutcomes measure: Preference - CDO Configuration, primaryOutcomes measure: Four Square Step Test (seconds), primaryOutcomes measure: Sit to Stand 5 Times (seconds), primaryOutcomes measure: Center of Pressure Velocity Magnitude (m/s), primaryOutcomes measure: Center of Pressure Velocity Timing (%stance), primaryOutcomes measure: Ankle Zero Moment Crossing (%stance), primaryOutcomes measure: Peak Ankle Dorsiflexion (degree), primaryOutcomes measure: Peak Ankle Plantarflexion Moment (Nm/kg), primaryOutcomes measure: Peak Ankle Push-Off Power (W/kg), secondaryOutcomes measure: PROMIS Satisfaction with Participation in Social Activities, secondaryOutcomes measure: PROMIS Satisfaction with Participation in Discretionary Social Activities, secondaryOutcomes measure: PROMIS Depression, otherOutcomes measure: 10 Meter Shuttle Run (seconds), otherOutcomes measure: Self Selected Walking Velocity (m/s), otherOutcomes measure: Ankle Range of Motion (degrees), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False