SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry

NCT04600102 | Withdrawn FDA Device

• 1 other identifier: 201907735
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Injuries and Disorders

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

  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

Study Arms (2)

GROUP 1

Healthy able-bodied individuals with no history of lower extremity trauma.

Device: Structure Sensor

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).

Device: Structure Sensor

Interventions

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.

GROUP 1; GROUP 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Use of an AFO that crosses the knee (includes Knee brace or similar)
• Open/unhealed wounds on lower extremity

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Foot Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 27, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)