SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry
- Conditions
- Foot Injuries and Disorders
- Interventions
- Device: Structure Sensor
- Registration Number
- NCT04600102
- Lead Sponsor
- University of Iowa
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description GROUP 2 Structure Sensor 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). GROUP 1 Structure Sensor Healthy able-bodied individuals with no history of lower extremity trauma.
- Primary Outcome Measures
Name Time Method Width of the metatarsal heads Less than 2 days Distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.
Foot height Less than 2 days Distance from the most superior point on the foot distal to the tibialis anterior insertion.
Arch height Less than 2 days Dorsum height at 50% foot length.
Medial-lateral ankle malleoli width Less than 2 days Distance from the lateral malleolus to the medial malleolus.
Minimum ankle circumference Less than 2 days Minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.
Width of the calcaneus Less than 2 days Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.
Foot length Less than 2 days Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).
Maximum calf circumference Less than 2 days Maximum calf circumference greater that 5 cm distal to the knee condyles.
Width of the knee condyles Less than 2 days Distance from the medial condyle to the lateral condyle.
Anterior-posterior width at patella Less than 2 days Distance from mid patellar tendon to a parallel point most posterior on the back of the knee.
Tibial tubercle height Less than 2 days Distance from the floor to tibial tubercle.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Iowa
🇺🇸Iowa City, Iowa, United States