From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
- Conditions
- Foot Injury
- Registration Number
- NCT06352788
- Lead Sponsor
- Jason Wilken
- Brief Summary
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.
- Detailed Description
This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influence outcomes following traumatic lower extremity injury. In this study, adult participants who still experiencing deficits including weakness and/or immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO.
Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order: a proposed optimal benchmark configuration, a variation with the device in more dorsiflexion, and a variation with the device in greater plantarflexion. Multiple well-established tests will be used to compare outcomes between the different configurations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
-
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
-
Any of the following:
- Weakness of ankle plantarflexors (<4/5 on manual muscle test)
- Limited pain-free ankle motion (dorsiflexion (DF) <10° or plantarflexion (PF) <20°)
- Mechanical pain with loading to hindfoot/midfoot (>=4/10 Numerical pain rating scale)
- Fusion or candidate for fusion of the ankle or hindfoot
- Candidate for amputation secondary to ankle/foot injury and impairment
- 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
- Surgery on study limb anticipated in next 4 months
- Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
- Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
- Uncorrected visual or hearing impairments
- Pregnancy
- Non-English speaking
- BMI > 40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method PROMIS Physical Function Baseline 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.
Preference - Ranked Baseline 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.
OPUS Satisfaction with Device and Services Baseline 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.
PROMIS Pain Interference Baseline 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.
Modified Socket Comfort Score - Comfort Baseline 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 - Smoothness Baseline 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.
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.
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.
Numerical Pain Rating Scale Baseline 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 - CDO Configuration Baseline 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.
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.
- Secondary Outcome Measures
Name Time Method PROMIS Depression Baseline 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.
PROMIS Satisfaction with Participation in Discretionary Social Activities Baseline 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.
PROMIS Satisfaction with Participation in Social Activities Baseline 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.
Trial Locations
- Locations (5)
Naval Medical Center San Diego - Clinical Biomechanics Laboratory
🇺🇸San Diego, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Minneapolis VA Health Care System - Motion Analysis Laboratory
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic - Motion Analysis Lab
🇺🇸Rochester, Minnesota, United States
Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
🇺🇸Nashville, Tennessee, United States
Naval Medical Center San Diego - Clinical Biomechanics Laboratory🇺🇸San Diego, California, United StatesTrevor Kingsbury, PhDContacttrevor.d.kingsbury.civ@health.mil