Iterative Design of Custom Dynamic Orthoses

Not Applicable

Completed

Conditions: Adult ALL
Healthy

Interventions: Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Registration Number: NCT04800510

Lead Sponsor: University of Iowa

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 9

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NoCDO, CDOA, CDOC, CDOB	Carbon Fiber Custom Dynamic Orthosis (CDO)	Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB.
NoCDO, CDOB, CDOA, CDOC	Carbon Fiber Custom Dynamic Orthosis (CDO)	Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC.
NoCDO, CDOA, CDOB, CDOC	Carbon Fiber Custom Dynamic Orthosis (CDO)	Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC.
NoCDO, CDOB, CDOC, CDOA	Carbon Fiber Custom Dynamic Orthosis (CDO)	Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA.
NoCDO, CDOC, CDOA, CDOB	Carbon Fiber Custom Dynamic Orthosis (CDO)	Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB.
NoCDO, CDOC, CDOB, CDOA	Carbon Fiber Custom Dynamic Orthosis (CDO)	Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA.

Primary Outcome Measures

Name	Time	Method
Joint Contact Stress-Time Exposure	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Peak Ankle Moment	Baseline	Peak ankle moment (Nm/kg) during gait.
Plantar Force (Hindfoot)	Baseline	Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait.
Ankle Range of Motion	Baseline	Peak dorsiflexion angle (degrees) during gait.
Plantar Force (Total Foot)	Baseline	Force data (N) collected across the total foot measured between the foot and orthosis during gait.
Modified Socket Comfort Score (Smoothness)	Baseline	Comfort scores range from 0 = least smooth to 10 = most smooth.
Peak Ankle Power	Baseline	Peak ankle power (W/kg) during gait.
Plantar Force (Forefoot)	Baseline	Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait.
Plantar Force (Midfoot)	Baseline	Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait.
Soleus Muscle Force (N)	Baseline	Peak Soleus muscle forces (N) will be estimated using an Opensim model
Gastrocnemius Muscle Force (N)	Baseline	Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model
Four Square Step Test (4SST)	Baseline	The 4SST (s) is a standardized timed test of balance and agility.
Numerical Pain Rating Scale	Baseline	Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Sit to Stand 5 Times (STS5)	Baseline	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.
The Orthotics Prosthetics Users' Survey (OPUS)	Baseline	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.
Modified Socket Comfort Score (Comfort)	Baseline	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.