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SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry

SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04600102
Enrollment
0
Registered
2020-10-23
Start date
2020-10-27
Completion date
2023-05-31
Last updated
2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Injuries and Disorders

Keywords

Ankle Foot Orthosis, Adult, 3D Limb Scanning, Limb Geometry, Limb Loading

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.

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.

Interventions

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.

Sponsors

University of Iowa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Foot lengthLess than 2 daysDistance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).
Width of the metatarsal headsLess than 2 daysDistance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.
Width of the calcaneusLess than 2 daysDistance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.
Foot heightLess than 2 daysDistance from the most superior point on the foot distal to the tibialis anterior insertion.
Arch heightLess than 2 daysDorsum height at 50% foot length.
Medial-lateral ankle malleoli widthLess than 2 daysDistance from the lateral malleolus to the medial malleolus.
Minimum ankle circumferenceLess than 2 daysMinimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.
Maximum calf circumferenceLess than 2 daysMaximum calf circumference greater that 5 cm distal to the knee condyles.
Width of the knee condylesLess than 2 daysDistance from the medial condyle to the lateral condyle.
Anterior-posterior width at patellaLess than 2 daysDistance from mid patellar tendon to a parallel point most posterior on the back of the knee.
Tibial tubercle heightLess than 2 daysDistance from the floor to tibial tubercle.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026