Iterative Design of Custom Dynamic Orthoses (PRMRP-Norms)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Adult ALL
• Intervention / Treatment: Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

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

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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
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
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
Peak Ankle Moment	Peak ankle moment (Nm/kg) during gait.	Baseline
Peak Ankle Power	Peak ankle power (W/kg) during gait.	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
Ankle Range of Motion	Peak dorsiflexion angle (degrees) 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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medial Gastrocnemius Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.	Baseline
Rectus Femoris Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.	Baseline
Vastus Medialis Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.	Baseline
Semi-Structured Interview	Semi-structured interviews will also be used to fully capture the patients' perspectives, experience, and opinions associated with the device options they experienced as part of the study.	Baseline
Soleus Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Soleus during gait.	Baseline
Tibialis Anterior Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait.	Baseline
Participant Device Preference	The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.	Baseline
Center of Pressure Velocity Timing	Timing of peak center of pressure velocity (percent stance) during gait.	Baseline
Center of Pressure Velocity Magnitude	Magnitude of peak center of pressure velocity (m/s) during gait.	Baseline

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Jason M Wilken, PT, PhD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): June 25, 2022
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Biomechanics; Gait Analysis; Carbon Fiber; Ankle Foot Orthosis
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Anti-Infective Agents, Local; Anti-Infective Agents; Carbon Fiber
• Other Study ID Numbers: 202002131; CDMRP-PR172087 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No