Foot Injuries and Disorders Clinical Trial
Official title:
SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry
NCT number | NCT04600102 |
Other study ID # | 201907735 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | October 27, 2020 |
Est. completion date | May 2023 |
Verified date | July 2022 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Width of the calcaneus | Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus. | Less than 2 days | |
Primary | Foot length | Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd). | Less than 2 days | |
Primary | Foot height | Distance from the most superior point on the foot distal to the tibialis anterior insertion. | Less than 2 days | |
Primary | Arch height | Dorsum height at 50% foot length. | Less than 2 days | |
Primary | Medial-lateral ankle malleoli width | Distance from the lateral malleolus to the medial malleolus. | Less than 2 days | |
Primary | 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 | |
Primary | Maximum calf circumference | Maximum calf circumference greater that 5 cm distal to the knee condyles. | Less than 2 days | |
Primary | Width of the knee condyles | Distance from the medial condyle to the lateral condyle. | Less than 2 days | |
Primary | 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 | |
Primary | Tibial tubercle height | Distance from the floor to tibial tubercle. | Less than 2 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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