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Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP 1 | Healthy able-bodied individuals with no history of lower extremity trauma. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structure Sensor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Width of the metatarsal heads | Distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head. | Less than 2 days |
| Width of the calcaneus | Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus. | Less than 2 days |
| Foot length | Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd). | Less than 2 days |
| Foot height | Distance from the most superior point on the foot distal to the tibialis anterior insertion. | Less than 2 days |
| Arch height | Dorsum height at 50% foot length. | Less than 2 days |
| Medial-lateral ankle malleoli width | Distance from the lateral malleolus to the medial malleolus. | Less than 2 days |
| Minimum ankle circumference | Minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli. | Less than 2 days |
| Maximum calf circumference | Maximum calf circumference greater that 5 cm distal to the knee condyles. |
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GROUP 1
Patient Inclusion criteria
Patient Exclusion criteria
GROUP 2
Patient Inclusion criteria
Patient Exclusion criteria
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Jason M Wilken, PT, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D018409 | Foot Injuries |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Less than 2 days |
| Width of the knee condyles | Distance from the medial condyle to the lateral condyle. | Less than 2 days |
| Anterior-posterior width at patella | Distance from mid patellar tendon to a parallel point most posterior on the back of the knee. | Less than 2 days |
| Tibial tubercle height | Distance from the floor to tibial tubercle. | Less than 2 days |