Evaluating Custom Dynamic Orthoses for Foot Injuries
This study is looking at how two types of custom dynamic orthoses (CDOs) – the Modular Carbon Fiber Custom Dynamic Orthosis and the Mono Carbon Fiber Custom Dynamic Orthosis – help people who have had a traumatic foot or lower leg injury. You might be able to join if you are between 18 and 65, and it's been at least two years since your injury, but you still have issues like ankle weakness or pain. The study wants to see how different ways of setting up these devices affect your physical function, pain, and how satisfied you are with the device. The study aims to enroll 35 participants, but its current status is unclear.
- Study design
- This is an interventional study where participants will be randomly assigned to receive either a modular or monolithic CDO. Outcomes will be compared using various tests.
- What's involved
- Participants will be evaluated without a CDO and then with the CDO in three different configurations.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your physical function, pain, and satisfaction with the device will be measured at baseline (when you start the study).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
At a glance
Conditions
NCT06352788
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic - Motion Analysis Lab
Rochester, Minnesotastudy coordinator listed
Recruiting
Minneapolis VA Health Care System - Motion Analysis Laboratory
Minneapolis, Minnesotastudy coordinator listed
Recruiting
Naval Medical Center San Diego - Clinical Biomechanics Laboratory
San Diego, Californiastudy coordinator listed
Recruiting
University of Iowa
Iowa City, Iowastudy coordinator listed
Recruiting
Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
Nashville, Tennesseestudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jason M Wilken, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Iowa
Who to contact
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Exclusion
What this trial measures
- PROMIS Physical FunctionBaseline
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.
- PROMIS Pain InterferenceBaseline
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.
- OPUS Satisfaction with Device and ServicesBaseline
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.
- Modified Socket Comfort Score - ComfortBaseline
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.
- Modified Socket Comfort Score - SmoothnessBaseline
Participants were asked to rate the smoothness of each CDO configuration on a scale from 0-10 with 0 = most smooth to 10 = least smooth. Lower scores indicate smoother conditions, and are considered better.
- Numerical Pain Rating ScaleBaseline
Pain will be assessed using a standard 11-point numerical pain rating scale (NPRS), in which 0 = no pain and 10 = worst pain imaginable. Lower scores are considered better.
- Preference - RankedBaseline
The participant will be asked to rank order the conditions they have completed testing for at each visit: at the 3rd visit they will rank order their preference for using no orthosis or using the CDO in the first configuration, at the 4th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, and using the CDO in the second configuration, at the 5th visit they will rank order their preference for using no orthosis, using the CDO in the first configuration, using the CDO in the second configuration, and using the CDO in the third configuration.
- Preference - CDO ConfigurationBaseline
For each CDO configuration, participants will be asked to rank their preference on a scale from 0 (least preferred) to 10 (most preferred) for a number of questions concerning CDO use. Higher scores indicate higher preferences and are considered better.
- Four Square Step Test (seconds)Baseline
The 4SST (seconds) is a standardized timed test of balance and agility. Participants start in the lower left quadrant of a Maltese cross setting on the floor and are timed as they move counterclockwise (forward, right, backward, left) and then clockwise (right, forward, left, backward) around the cross. Participants are instructed to move as quickly as they safely can. Lower times indicate faster completion of the test and are considered better results.
- Sit to Stand 5 Times (seconds)Baseline
STS5 (seconds) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible. Lower scores indicate a faster time to complete the test and are considered better results.
- Center of Pressure Velocity Magnitude (m/s)Baseline
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The magnitude of the peak center of pressure velocity (m/s) is the fastest the CoP moves during gait.
- Center of Pressure Velocity Timing (%stance)Baseline
The center of pressure (CoP) is the centroid of the forces acting on the foot during gait. The timing of the peak center of pressure velocity, is the percent of the stance phase (%stance) where the CoP is moving fastest during gait.
- Ankle Zero Moment Crossing (%stance)Baseline
The ankle zero moment crossing is the point during the stance phase of gait (%stance) where the ankle moment transitions from a dorsiflexion to a plantarflexion moment.
- Peak Ankle Dorsiflexion (degree)Baseline
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint dorsiflexion angle (degree) that occurs late in the stance phase of gait.
- Peak Ankle Plantarflexion Moment (Nm/kg)Baseline
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint plantarflexion moment normalized to participant body weight (Nm/kg) that occurs late in the stance phase of gait.
- Peak Ankle Push-Off Power (W/kg)Baseline
Participants completed a biomechanical gait analysis session. Sagittal plane peak ankle joint power normalized to body weight (W/kg) occurs late in the stance phase of gait.