Iterative Design of Custom Dynamic Orthoses

Healthy Clinical Trial

— PRMRP-Norms  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800510
• Other study ID #: 202002131
• Status: Completed
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: June 25, 2022

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult ALL
• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Center of Pressure Velocity Timing	Timing of peak center of pressure velocity (percent stance) during gait.	Baseline
Other	Center of Pressure Velocity Magnitude	Magnitude of peak center of pressure velocity (m/s) during gait.	Baseline
Other	Soleus Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Soleus during gait.	Baseline
Other	Rectus Femoris Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.	Baseline
Other	Vastus Medialis Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.	Baseline
Other	Medial Gastrocnemius Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.	Baseline
Other	Tibialis Anterior Muscle Activity (Electromyography)	Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait.	Baseline
Primary	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	Ankle Range of Motion	Peak dorsiflexion angle (degrees) during gait.	Baseline
Secondary	Peak Ankle Moment	Peak ankle moment (Nm/kg) during gait.	Baseline
Secondary	Peak Ankle Power	Peak ankle power (W/kg) during gait.	Baseline
Secondary	Plantar Force (Total Foot)	Force data (N) collected across the total foot measured between the foot and orthosis during gait.	Baseline
Secondary	Plantar Force (Forefoot)	Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait.	Baseline
Secondary	Plantar Force (Midfoot)	Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait.	Baseline
Secondary	Plantar Force (Hindfoot)	Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait.	Baseline
Secondary	Four Square Step Test (4SST)	The 4SST (s) is a standardized timed test of balance and agility.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Soleus Muscle Force (N)	Peak Soleus muscle forces (N) will be estimated using an Opensim model	Baseline
Secondary	Gastrocnemius Muscle Force (N)	Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model	Baseline
Secondary	Modified Socket Comfort Score (Comfort)	Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.	Baseline
Secondary	Modified Socket Comfort Score (Smoothness)	Comfort scores range from 0 = least smooth to 10 = most smooth.	Baseline