Status:
TERMINATED
SCANREP: Reliability of 3D Lower Limb Scanning
Lead Sponsor:
University of Iowa
Conditions:
Foot Injuries and Disorders
Eligibility:
All Genders
18-75 years
Brief Summary
3D limb scanning systems have recently been implemented for the clinical fitting of prosthetic and orthotic devices due to substantial decreases in costs. However, little data is available regarding t...
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)...
Eligibility Criteria
Inclusion
- 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.
- BMI greater than 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
- BMI greater than 35
- Diagnoses of a moderate to severe brain injury
Exclusion
Key Trial Info
Start Date :
September 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04032041
Start Date
September 27 2019
End Date
July 5 2022
Last Update
January 10 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242