Clinical trial NCT04800510: Iterative Design of Custom Dynamic Orthoses
Official title: Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult ALL
Healthy
Keywords: Gait Analysis
Ankle Foot Orthosis
Carbon Fiber
Biomechanics
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will use three generic sized carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results.
Primary purpose: OTHER

Brief summary: The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.

Detailed description: The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.

Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.

The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 50
* Shoe size between women's 8 and 13.5 or men's 6.5 and 12
* Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
* Full active range of motion of the bilateral lower extremities and spine
* Ability to hop without pain
* Ability to perform a full squat without pain
* Ability to read and write in English and provide written informed consent

Exclusion Criteria:

* Diagnosed moderate or severe brain injury
* Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
* Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
* Visual or hearing impairment that would interfere with instructions given during testing
* Require an assistive device
* Wounds to the foot or calf that would prevent CDO use
* BMI greater than 35
* Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study

Primary outcomes:
measure: Joint Contact Stress-Time Exposure
timeFrame: Baseline
Secondary outcomes:
measure: Ankle Range of Motion
timeFrame: Baseline
measure: Peak Ankle Moment
timeFrame: Baseline
measure: Peak Ankle Power
timeFrame: Baseline
measure: Plantar Force (Total Foot)
timeFrame: Baseline
measure: Plantar Force (Forefoot)
timeFrame: Baseline
measure: Plantar Force (Midfoot)
timeFrame: Baseline
measure: Plantar Force (Hindfoot)
timeFrame: Baseline
measure: Four Square Step Test (4SST)
timeFrame: Baseline
measure: Sit to Stand 5 Times (STS5)
timeFrame: Baseline
measure: Numerical Pain Rating Scale
timeFrame: Baseline
measure: The Orthotics Prosthetics Users' Survey (OPUS)
timeFrame: Baseline
measure: Soleus Muscle Force (N)
timeFrame: Baseline
measure: Gastrocnemius Muscle Force (N)
timeFrame: Baseline
measure: Modified Socket Comfort Score (Comfort)
timeFrame: Baseline
measure: Modified Socket Comfort Score (Smoothness)
timeFrame: Baseline
Other outcomes:
measure: Participant Device Preference
timeFrame: Baseline
measure: Semi-Structured Interview
timeFrame: Baseline
measure: Center of Pressure Velocity Timing
timeFrame: Baseline
measure: Center of Pressure Velocity Magnitude
timeFrame: Baseline
measure: Soleus Muscle Activity (Electromyography)
timeFrame: Baseline
measure: Rectus Femoris Muscle Activity (Electromyography)
timeFrame: Baseline
measure: Vastus Medialis Muscle Activity (Electromyography)
timeFrame: Baseline
measure: Medial Gastrocnemius Muscle Activity (Electromyography)
timeFrame: Baseline
measure: Tibialis Anterior Muscle Activity (Electromyography)
timeFrame: Baseline
Locations:
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jason M Wilken, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: