Iterative Design of Custom Dynamic Orthoses

Study Overview
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Brief Summary
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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
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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

Official Title
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Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model

Conditions
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Adult ALL, Healthy

Intervention / Treatment
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* Device: Carbon Fiber Custom Dynamic Orthosis (CDO)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NoCDO, CDOA, CDOB, CDOC<br>Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)<br>* The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.<br>* Other names: Ankle Foot Orthosis;|
| Experimental: NoCDO, CDOA, CDOC, CDOB<br>Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)<br>* The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.<br>* Other names: Ankle Foot Orthosis;|
| Experimental: NoCDO, CDOB, CDOA, CDOC<br>Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)<br>* The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.<br>* Other names: Ankle Foot Orthosis;|
| Experimental: NoCDO, CDOB, CDOC, CDOA<br>Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)<br>* The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.<br>* Other names: Ankle Foot Orthosis;|
| Experimental: NoCDO, CDOC, CDOA, CDOB<br>Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)<br>* The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.<br>* Other names: Ankle Foot Orthosis;|
| Experimental: NoCDO, CDOC, CDOB, CDOA<br>Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)<br>* The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.<br>* Other names: Ankle Foot Orthosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Contact Stress-Time Exposure | Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle Range of Motion | Peak dorsiflexion angle (degrees) during gait. | Baseline | 
| Peak Ankle Moment | Peak ankle moment (Nm/kg) during gait. | Baseline | 
| Peak Ankle Power | Peak ankle power (W/kg) during gait. | Baseline | 
| Plantar Force (Total Foot) | Force data (N) collected across the total foot measured between the foot and orthosis during gait. | Baseline | 
| Plantar Force (Forefoot) | Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait. | Baseline | 
| Plantar Force (Midfoot) | Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait. | Baseline | 
| Plantar Force (Hindfoot) | Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait. | Baseline | 
| Four Square Step Test (4SST) | The 4SST (s) is a standardized timed test of balance and agility. | Baseline | 
| Sit to Stand 5 Times (STS5) | STS5 (s) 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. | Baseline | 
| Numerical Pain Rating Scale | Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. | Baseline | 
| The Orthotics Prosthetics Users' Survey (OPUS) | Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0. | Baseline | 
| Soleus Muscle Force (N) | Peak Soleus muscle forces (N) will be estimated using an Opensim model | Baseline | 
| Gastrocnemius Muscle Force (N) | Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model | Baseline | 
| Modified Socket Comfort Score (Comfort) | Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. | Baseline | 
| Modified Socket Comfort Score (Smoothness) | Comfort scores range from 0 = least smooth to 10 = most smooth. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics