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SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry

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ClinicalTrials.gov Identifier: NCT04600102
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Jason Wilken, University of Iowa

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Orthotists currently use a range of weight bearing conditions when casting or scanning a patient's limb during the Ankle foot orthosis (AFO) fitting process. This variability in clinical practice is the result of differing opinions regarding the best method for fitting, and a limited understanding of how weight bearing affects the resulting geometry. Few studies have been performed to determine the effect of weight bearing on resulting geometry, or the consistency of the geometry obtained. In this study we seek to evaluate the effect of foot loading on lower limb geometry and the consistency of measurements using low-cost 3D scanning technology, with implications for fitting AFOs.

Condition or disease Intervention/treatment
Foot Injuries and Disorders Device: Structure Sensor

Detailed Description:

Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).

We will obtain a brief medical history to identify major medical conditions or prior injuries that could influence limb geometry and lead to reliance on an AFO for Group 2 participants.

A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.), which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the scanner, the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed. Measurements will be evaluated using digital imaging analysis software (Standard Cyborg, Inc.). The different conditions being tested are full weight bearing, partial weight bearing, and non-weight bearing. The effect of limb loading on multiple measures of limb geometry will be evaluated. Limb measurements will include 1) width of the metatarsal heads, 2) width of the calcaneus, 3) foot length, 4) foot height, 5) arch height, 6) medial-lateral width between ankle malleoli, 7) minimum circumference above the ankle malleoli, 8) maximum calf circumference , 9) medial-lateral width of the knee condyles 10) anterior-posterior width at mid patellar tendon, 11) distance from bottom of foot to tibial tubercle.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Days
Official Title: SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry
Actual Study Start Date : October 27, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
GROUP 1
Healthy able-bodied individuals with no history of lower extremity trauma.
 Device: Structure Sensor
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Sensor scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
GROUP 2
Individuals with unilateral, below knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
 Device: Structure Sensor
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Sensor scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.


Outcome Measures
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Primary Outcome Measures :
  1. Width of the metatarsal heads [ Time Frame: Less than 2 days ]
    Distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.

  2. Width of the calcaneus [ Time Frame: Less than 2 days ]
    Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.

  3. Foot length [ Time Frame: Less than 2 days ]
    Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).

  4. Foot height [ Time Frame: Less than 2 days ]
    Distance from the most superior point on the foot distal to the tibialis anterior insertion.

  5. Arch height [ Time Frame: Less than 2 days ]
    Dorsum height at 50% foot length.

  6. Medial-lateral ankle malleoli width [ Time Frame: Less than 2 days ]
    Distance from the lateral malleolus to the medial malleolus.

  7. Minimum ankle circumference [ Time Frame: Less than 2 days ]
    Minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.

  8. Maximum calf circumference [ Time Frame: Less than 2 days ]
    Maximum calf circumference greater that 5 cm distal to the knee condyles.

  9. Width of the knee condyles [ Time Frame: Less than 2 days ]
    Distance from the medial condyle to the lateral condyle.

  10. Anterior-posterior width at patella [ Time Frame: Less than 2 days ]
    Distance from mid patellar tendon to a parallel point most posterior on the back of the knee.

  11. Tibial tubercle height [ Time Frame: Less than 2 days ]
    Distance from the floor to tibial tubercle.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
Criteria

GROUP 1

Patient Inclusion criteria

  • Ages: 18-75
  • Healthy individuals without a current complaint of lower extremity pain, spine pain, active infections or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
  • Ability to perform a full squat without pain
  • Able to read and write in English and provide written informed consent

Patient Exclusion criteria

  • Diagnosed moderate or severe brain injury
  • Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
  • Current complaint of pain or numbness in the spine
  • Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing
  • Require an assistive device
  • Open/unhealed wounds on lower extremity.
  • Body mass index (BMI) above 35

GROUP 2

Patient Inclusion criteria

  • Ages: 18-75
  • Daily AFO use to address unilateral below knee functional deficits (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease)
  • Ability to stand independently without use of an assistive device (Cane, crutch, etc)
  • Ability to safely bear full body weight on affected limb without use of an AFO or other protection
  • Able to read and write in English and provide written informed consent

Patient Exclusion criteria

  • Use of an AFO that crosses the knee (includes Knee brace or similar)
  • Open/unhealed wounds on lower extremity
  • Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing
  • Body mass index (BMI) above 35
  • Diagnoses of a moderate to severe brain injury
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04600102


Contacts
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Contact: Jason M Wilken, PT, PhD 319-335-6857 jason-wilken@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jason M Wilken, PT, PhD    319-335-6857    jason-wilken@uiowa.edu   
Contact: Molly Pacha, MS, ATC, LAT    319-290-7596    molly-pacha@uiowa.edu   
Sub-Investigator: Jeff Palmer, CPO, LPO         
Sub-Investigator: Molly Pacha, MS, ATC, LAT         
Sub-Investigator: Natalie Glass, PhD         
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Jason M Wilken, PT, PhD University of Iowa
More Information
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Responsible Party: Jason Wilken, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT04600102    
Other Study ID Numbers: IRB# 201907735
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 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:
Ankle Foot Orthosis
Adult
3D Limb Scanning
Limb Geometry
Limb Loading
Additional relevant MeSH terms:
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Foot Injuries
Leg Injuries
Wounds and Injuries