From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
ConditionFoot Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJason Wilken
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 18 and 65
2 or more years from a traumatic injury below the knee
Ability to be fit with an orthosis
Weakness of ankle plantarflexors (<4/5 on manual muscle test)
Disqualifiers
Pain greater than 8/10 at rest
Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
Use of an orthosis including the knee
Non-ambulatory
Trial design
Design model
Crossover
Treatments tested in this trial
Modular Carbon Fiber Custom Dynamic Orthosis (CDO)
DeviceThe CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
Mono Carbon Fiber Custom Dynamic Orthosis (CDO)
DeviceThe CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.
Treatment groups
35 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: NoCDO, A, B, CExperimental treatment 2 interventions
Group B: NoCDO, A, C, BExperimental treatment 2 interventions
Group C: NoCDO, B, A, CExperimental treatment 2 interventions
Group D: NoCDO, B, C, AExperimental treatment 2 interventions
Group E: NoCDO, C, A, BExperimental treatment 2 interventions
Group F: NoCDO, C, B, AExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
PROMIS Physical Function
The Patient Reported Outcome Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) is a computerized assessment measuring physical function. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater physical function than the population average. Larger scores are better.
Time frame
Baseline2
PROMIS Pain Interference
The Patient Reported Outcome Information System (PROMIS) Pain Interference Computer Adaptive Test (CAT) is a computerized assessment measuring pain interference. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater pain interference than the population average. Lower scores are better.
Time frame
Baseline3
OPUS Satisfaction with Device and Services
Satisfaction with device and services will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device and Services Score (11-55). Lower scores indicate a better outcome and more satisfaction with the CDO and accompanying services.
Time frame
Baseline4
Modified Socket Comfort Score - Comfort
Participants were asked to rate the comfort of each CDO configuration on a scale from 0-10 with 0 = most uncomfortable to 10 = most comfortable. Higher scores indicate more comfortable conditions, and are considered better.
Time frame
BaselineSecondary outcomes
1
PROMIS Satisfaction with Participation in Social Activities
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater participation in social activities than the population average, larger scores are considered better.
Time frame
Baseline2
PROMIS Satisfaction with Participation in Discretionary Social Activities
The Patient Reported Outcome Information System (PROMIS) satisfaction with participation in social activities Computer Adaptive Test (CAT) is a computerized assessment measuring satisfaction with participation in social activities. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater participation in discretionary social activities than the population average, larger scores are considered better.
Time frame
Baseline3
PROMIS Depression
The Patient Reported Outcome Information System (PROMIS) depression Computer Adaptive Test (CAT) is a computerized assessment measuring depression. It is scored using a T-score in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. In a given PROMIS domain, a T-score above 50 represents greater levels of depression than the population average, lower scores are considered better.
Time frame
BaselineOther outcomes
1
Ankle Range of Motion (degrees)
Participants completed a biomechanical gait analysis session. Sagittal plane ankle range of motion (degrees) was measured throughout the gait cycle. Smaller range of motion is expected with each CDO.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jason Wilken
Lead sponsor
University of Iowa
Sponsor institution
Mayo Clinic
Collaborator
Vanderbilt University Medical Center
Collaborator
Navy Medical Center San Diego
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov