Iterative Design of Custom Dynamic Orthoses

University of Iowa9 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Adult ALL Healthy

Interventions

Carbon Fiber Custom Dynamic Orthosis (CDO)DEVICE

The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

Ankle Range of Motion

Peak dorsiflexion angle (degrees) during gait.

Time frame: Baseline

Peak Ankle Moment

Peak ankle moment (Nm/kg) during gait.

Time frame: Baseline

Peak Ankle Power

Peak ankle power (W/kg) during gait.

Time frame: Baseline

Plantar Force (Total Foot)

Force data (N) collected across the total foot measured between the foot and orthosis during gait.

Time frame: Baseline

Plantar Force (Forefoot)

Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait.

Time frame: Baseline

Plantar Force (Midfoot)

Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait.

Time frame: Baseline

Plantar Force (Hindfoot)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.