Clinical trial NCT06710119: Effect of Custom Dynamic Orthoses on Forefoot Loading
Official title: Effect of Custom Dynamic Orthoses on Forefoot Loading
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Extremity Injuries
Keywords: Gait Analysis
Ankle Foot Orthosis
Carbon Fiber
Biomechanics
Visual Feedback
Foot Loading
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Cornerstone Clinics, Everett, WA
First posted: 2024-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will either receive training with or without visual feedback of foot loading during gait.
Primary purpose: OTHER

Brief summary: The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.

Detailed description: This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.

Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).

Eligibility criteria: Patient Inclusion criteria

* Ages: 18-65
* Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
* Shoe size between women's 8 and 13.5 or men's 6.5 and 13
* Any of the following: weakness of ankle plantarflexors (\<4/5 on MMT), limited pain free ankle motion (DF\<10deg or PF\<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (\>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
* Ability to walk 25 feet without using a cane or crutch
* Ability to walk at a slow to moderate pace
* Able to read and write in English and provide written informed consent

Patient Exclusion criteria

* Pain \> 9/10 while walking
* Ankle weakness as a result of spinal cord injury or central nervous system pathology
* AFO or CDO prescription that includes a knee brace or goes up to thigh
* Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
* Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
* BMI greater than 40
* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
* Pregnancy

Primary outcomes:
measure: Peak Plantar Force (Forefoot)
timeFrame: Baseline
measure: Plantar Force Impulse (Forefoot)
timeFrame: Baseline
Secondary outcomes:
measure: Peak Plantar Force (Midfoot)
timeFrame: Baseline
measure: Plantar Force Impulse (Midfoot)
timeFrame: Baseline
measure: Peak Plantar Force (Hindfoot)
timeFrame: Baseline
measure: Plantar Force Impulse (Hindfoot)
timeFrame: Baseline
measure: Peak Plantar Force (Total Foot)
timeFrame: Baseline
measure: Plantar Force Impulse (Total Foot)
timeFrame: Baseline
Other outcomes:
measure: Modified Socket Comfort Score (Comfort)
timeFrame: Baseline
measure: Modified Socket Comfort Score (Smoothness)
timeFrame: Baseline
measure: Numerical Pain Rating Scale
timeFrame: Baseline
measure: Patient Reported Outcome Measurement Information System (Physical Function)
timeFrame: Baseline
measure: Patient Reported Outcome Measurement Information System (Pain Interference)
timeFrame: Baseline
measure: Orthotics and Prosthetics User Survey - Satisfaction with Service
timeFrame: Baseline
measure: Orthotics and Prosthetics User Survey - Satisfaction with Device
timeFrame: Baseline
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Everett
country: United States
facility: Cornerstone Prosthetics and Orthotics
state: Washington
Study officials:
References: