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Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress (PRMRP-FPA2)

Primary Purpose

Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom Carbon Fiber Dynamic Orthosis (CDO)
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ankle Fractures focused on measuring Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

TIBIAL PILON FRACTURE PARTICIPANTS:

Inclusion Criteria:

  • Ages: 18-65
  • Sustained unilateral fracture of the tibial pilon within the preceding 5 years
  • The fracture has completely healed
  • Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.)
  • Ability to walk at a slow to moderate pace
  • Shoe size between women's 8 and 13.5 or men's 6.5 and 12
  • Ability to read and write in English and provide written informed consent
  • Individuals with elevated contact stress according to model generated using PedCAT standing CT images (will be answered after completing visit one)

Exclusion Criteria:

  • Pain > 6/10 while walking
  • Increase in pain during testing of 3/10 or greater
  • Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity
  • Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease)
  • Wounds to the calf that would prevent CDO fitting
  • Fractures secondary to neuropathy or severe osteopenia
  • Classification as non-ambulatory
  • Previous fractures near the tibial pilon on the involved limb
  • Surgery on involved limb anticipated in the next 6 months
  • Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • BMI greater than 40
  • 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of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study.

HEALTHY ABLE-BODIED PARTICIPANTS:

Patient Inclusion Criteria

  • Between the ages of 18 and 65
  • 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

Patient 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 40
  • 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

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

No Device

CDO-A

CDO-B

CDO-C

Arm Description

Participants will be evaluated without a CDO.

The first design variant will be designated CDO-A

The second design variant will be designated CDO-B

The third design variant will be designated CDO-C

Outcomes

Primary Outcome Measures

Joint Contact Stress Time Exposure (Model estimated)
Joint contact stress time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.

Secondary Outcome Measures

Peak Soleus Muscle Force (model estimated)
Peak soleus muscle force (N) during gait will be estimated using a participant specific musculoskeletal model.
Peak Gastrocnemius Muscle Force (model estimated)
Peak gastrocnemius muscle force (N) during gait will be estimated using a participant specific musculoskeletal model.
Ankle Range of Motion
Peak ankle dorsiflexion (degrees) during gait.
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Plantar Force (Total Foot)
Force data (N) collected from the total foot, measured between the foot and orthosis during gait.
Plantar Force (Forefoot)
Force data (N) collected from the forefoot, measured between the foot and orthosis during gait.
Plantar Force (Midfoot)
Force data (N) collected from the midfoot, measured between the foot and orthosis during gait.
Plantar Force (Hindfoot)
Force data (N) collected from the hindfoot, measured between the foot and orthosis during gait.
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility.
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.

Full Information

First Posted
August 31, 2020
Last Updated
August 4, 2023
Sponsor
University of Iowa
Collaborators
University of Delaware, Bio-Mechanical Composites
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1. Study Identification

Unique Protocol Identification Number
NCT04562896
Brief Title
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
Acronym
PRMRP-FPA2
Official Title
Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
University of Delaware, Bio-Mechanical Composites

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. Research suggests that ankle arthritis develops after ankle fracture, in part, due to elevated forces on the cartilage. It is expected that carbon fiber braces can be designed to reduce forces in the ankle joint and thereby reduce the risk of developing arthritis following traumatic injury. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The proposed study will provide evidence that can be used by clinicians and researchers to design braces that most effectively reduce forces on ankle cartilage.
Detailed Description
The primary purpose of this line of research is to investigate the effects of carbon fiber custom dynamic orthosis (CDO) design on the forces and contact stress at the ankle, with the goal of reducing the development of post traumatic osteoarthritis (PTOA) in the ankle. Research suggests that ankle arthritis develops, in part, due to increased contact stresses within the ankle joint following fracture. It is expected that reducing articular contact stress at the ankle has the potential to delay or prevent the development of PTOA. CDOs have been shown to significantly improve function following extremity injury, and show promise for offloading the injured limb after severe lower extremity injuries. Therefore, the proposed effort is designed to evaluate how different CDO design factors influence offloading and therefore the reduction of forces and articular contact stress at the ankle. Adult participants will be evaluated while wearing carbon fiber braces of varied geometry. The primary dependent measure is ankle joint contact stress. Following consent and enrollment computerized tomography (CT) images will be used to determine the geometry of the joint articular surfaces. Ankle contact stress will be calculated using discrete element analysis and biomechanical data collected in subsequent data collection. Participants will be cast and fit for three CDOs with varied geometry. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Post-traumatic Osteoarthritis, Osteoarthritis Ankle
Keywords
Carbon Fiber, Gait Analysis, Ankle Foot Orthosis, Arthritis, Biomechanics, Ankle, Adult

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will be cast and fit with three 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. Multiple rounds of evaluation (~5 rounds) with small groups of participants in each round (n=~6) will be used.
Masking
Participant
Masking Description
Participants will be blinded to the different design variations of each device, and will only be introduced to each device as CDO-A, CDO-B or CDO-C.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Device
Arm Type
No Intervention
Arm Description
Participants will be evaluated without a CDO.
Arm Title
CDO-A
Arm Type
Experimental
Arm Description
The first design variant will be designated CDO-A
Arm Title
CDO-B
Arm Type
Experimental
Arm Description
The second design variant will be designated CDO-B
Arm Title
CDO-C
Arm Type
Experimental
Arm Description
The third design variant will be designated CDO-C
Intervention Type
Device
Intervention Name(s)
Custom Carbon Fiber Dynamic Orthosis (CDO)
Other Intervention Name(s)
Ankle Foot Orthosis
Intervention Description
The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
Primary Outcome Measure Information:
Title
Joint Contact Stress Time Exposure (Model estimated)
Description
Joint contact stress time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Peak Soleus Muscle Force (model estimated)
Description
Peak soleus muscle force (N) during gait will be estimated using a participant specific musculoskeletal model.
Time Frame
Baseline
Title
Peak Gastrocnemius Muscle Force (model estimated)
Description
Peak gastrocnemius muscle force (N) during gait will be estimated using a participant specific musculoskeletal model.
Time Frame
Baseline
Title
Ankle Range of Motion
Description
Peak ankle dorsiflexion (degrees) during gait.
Time Frame
Baseline
Title
Peak Ankle Moment
Description
Peak ankle moment (Nm/kg) during gait.
Time Frame
Baseline
Title
Peak Ankle Power
Description
Peak ankle power (W/kg) during gait.
Time Frame
Baseline
Title
Plantar Force (Total Foot)
Description
Force data (N) collected from the total foot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Plantar Force (Forefoot)
Description
Force data (N) collected from the forefoot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Plantar Force (Midfoot)
Description
Force data (N) collected from the midfoot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Plantar Force (Hindfoot)
Description
Force data (N) collected from the hindfoot, measured between the foot and orthosis during gait.
Time Frame
Baseline
Title
Four Square Step Test (4SST)
Description
The 4SST (s) is a standardized timed test of balance and agility.
Time Frame
Baseline
Title
Sit to Stand 5 Times (STS5)
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
The Orthotics Prosthetics Users' Survey (OPUS)
Description
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Time Frame
Baseline
Title
Modified Socket Comfort Score (Comfort and Smoothness)
Description
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
Time Frame
Baseline
Title
Numerical Pain Rating Scale
Description
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Time Frame
Baseline
Title
Participant Device Preference
Description
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.
Time Frame
After completing other study activities
Title
Semi-Structured Interview
Description
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.
Time Frame
Baseline
Title
Center of pressure velocity timing
Description
Timing of peak center of pressure velocity (percent stance) during gait.
Time Frame
Baseline
Title
Center of pressure velocity magnitude
Description
Magnitude of peak center of pressure velocity (m/s) during gait.
Time Frame
Baseline
Title
Soleus Muscle Activity (Electromyography)
Description
Electromyography (EMG, % Maximum) of the soleus during gait.
Time Frame
Baseline
Title
Tibialis Anterior Muscle Activity (Electromyography)
Description
Electromyography (EMG, % Maximum) of theTibialis Anterior during gait.
Time Frame
Baseline
Title
Medial Gastrocnemius Muscle Activity (Electromyography)
Description
Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.
Time Frame
Baseline
Title
Rectus Femoris Muscle Activity (Electromyography)
Description
Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.
Time Frame
Baseline
Title
Vastus Medialis Muscle Activity (Electromyography)
Description
Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
TIBIAL PILON FRACTURE PARTICIPANTS: Inclusion Criteria: Ages: 18-65 Sustained unilateral fracture of the tibial pilon within the preceding 5 years The fracture has completely healed Ability to walk 50 feet without use of an assistive device (cane, crutch, etc.) Ability to walk at a slow to moderate pace Shoe size between women's 8 and 13.5 or men's 6.5 and 13 Ability to read and write in English and provide written informed consent Individuals with elevated contact stress according to model generated using PedCAT standing CT images (will be answered after completing visit one) Exclusion Criteria: Pain > 6/10 while walking Increase in pain during testing of 3/10 or greater Neurologic, musculoskeletal (including bilateral fractures) or other condition limiting function of the contralateral extremity Medical or psychological condition that would preclude functional testing (ex. moderate or severe brain injury, stroke, heart disease) Wounds to the calf that would prevent CDO fitting Fractures secondary to neuropathy or severe osteopenia Classification as non-ambulatory Previous fractures near the tibial pilon on the involved limb Surgery on involved limb anticipated in the next 6 months Requirement of a knee stabilizing device (i.e. KAFO, KO…) to perform daily activities Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing BMI greater than 40 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. HEALTHY ABLE-BODIED PARTICIPANTS: Patient Inclusion Criteria Between the ages of 18 and 65 Shoe size between women's 8 and 13.5 or men's 6.5 and 13 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 Patient 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 40 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason M Wilken, PT, PhD
Phone
319-335-6857
Email
jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsten Anderson, BSE
Phone
319-353-0431
Email
kirsten-m-anderson@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason M. Wilken, PT, PhD
Phone
319-335-6857
Email
jason-wilken@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Molly Pacha, MS, ATC, LAT
Phone
319-290-7596
Email
molly-pacha@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Molly Pacha, MS, ATC, LAT
First Name & Middle Initial & Last Name & Degree
Michael C Willey, MD
First Name & Middle Initial & Last Name & Degree
Jeff Palmer, CPO, LPO
First Name & Middle Initial & Last Name & Degree
Donald D Anderson, PhD
First Name & Middle Initial & Last Name & Degree
Jason M Wilken, PT, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

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