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Iterative Design of Custom Dynamic Orthoses (PRMRP-Norms)

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ClinicalTrials.gov Identifier: NCT04800510
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Wilken, 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.

Condition or disease Intervention/treatment Phase
Adult ALL Healthy Device: Carbon Fiber Custom Dynamic Orthosis (CDO) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will use three generic sized 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.
Masking: Single (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.
Primary Purpose: Other
Official Title: Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: NoCDO
Participants will be evaluated without a CDO.
Experimental: CDO-A
The first design variant will be designated CDO-A.
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 Name: Ankle Foot Orthosis

Experimental: CDO-B
The second design variant will be designated CDO-B.
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 Name: Ankle Foot Orthosis

Experimental: CDO-C
The third design variant will be designated CDO-C.
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 Name: Ankle Foot Orthosis




Primary Outcome Measures :
  1. Joint Contact Stress Exposure (Model estimated) [ Time Frame: Baseline ]
    Joint contact stress exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model.


Secondary Outcome Measures :
  1. Four Square Step Test (4SST) [ Time Frame: Baseline ]
    The 4SST (s) is a standardized timed test of balance and agility.

  2. Sit to Stand 5 Times (STS5) [ Time Frame: 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.

  3. Ankle Range of Motion [ Time Frame: Baseline ]
    Ankle range of motion (degrees) during gait.

  4. Peak Ankle Moment [ Time Frame: Baseline ]
    Peak ankle moment (Nm/kg) during gait.

  5. Peak Ankle Power [ Time Frame: Baseline ]
    Peak ankle power (W/kg) during gait.

  6. Center of pressure velocity timing [ Time Frame: Baseline ]
    Timing of peak center of pressure velocity (percent stance) during gait.

  7. Center of pressure velocity magnitude [ Time Frame: Baseline ]
    Magnitude of peak center of pressure velocity (m/s) during gait.

  8. Soleus Muscle Activity (Electromyography) [ Time Frame: Baseline ]
    Electromyography (EMG, % Maximum) of the Soleus during gait.

  9. Tibialis Anterior Muscle Activity (Electromyography) [ Time Frame: Baseline ]
    Electromyography (EMG, % Maximum) of the Tibialis Anterior during gait.

  10. Medial Gastrocnemius Muscle Activity (Electromyography) [ Time Frame: Baseline ]
    Electromyography (EMG, % Maximum) of the Medial Gastrocnemius during gait.

  11. Rectus Femoris Muscle Activity (Electromyography) [ Time Frame: Baseline ]
    Electromyography (EMG, % Maximum) of the Rectus Femoris during gait.

  12. Vastus Medialis Muscle Activity (Electromyography) [ Time Frame: Baseline ]
    Electromyography (EMG, % Maximum) of the Vastus Medialis during gait.

  13. Plantar Force [ Time Frame: Baseline ]
    Force data (N) collected from the hind foot, mid foot, and forefoot, measured between the foot and orthosis during gait.


Other Outcome Measures:
  1. The Orthotics Prosthetics Users' Survey (OPUS) [ Time Frame: Baseline ]
    Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.

  2. Modified Socket Comfort Score (Comfort and Smoothness) [ Time Frame: Baseline ]
    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.

  3. Numerical Pain Rating Scale [ Time Frame: Baseline ]
    Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.

  4. Participant Device Preference [ Time Frame: Baseline ]
    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.

  5. Semi-Structured Interview [ Time Frame: Baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800510


Contacts
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Contact: Jason M Wilken, PT, PhD 319-335-6857 jason-wilken@uiowa.edu
Contact: Kirsten M Anderson, BSE 319-353-0431 kirsten-m-anderson@uiowa.edu

Locations
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United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jason M Wilken, PT, PhD    319-335-6857    jason-wilken@uiowa.edu   
Contact: Kirsten M Anderson, BSE    319-353-0431    kirsten-m-anderson@uiowa.edu   
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Jason M Wilken, PT, PhD University of Iowa
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Responsible Party: Jason Wilken, Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04800510    
Other Study ID Numbers: 202002131
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Jason Wilken, University of Iowa:
Gait Analysis
Ankle Foot Orthosis
Carbon Fiber
Biomechanics
Additional relevant MeSH terms:
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Carbon Fiber
Anti-Infective Agents, Local
Anti-Infective Agents