Foot Injuries and DisordersNCT04032041

SCANREP: Reliability of 3D Lower Limb Scanning

An observational study of Foot Injuries and Disorders, run by University of Iowa at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Foot Injuries and Disorders
What is being tested?: Structure Sensor and Caliper
Type of treatment: Medical device
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 27 Sep 2019to 5 Jul 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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).

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

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 the repeatability and validity of systems currently in use. In this study the investigators seek to evaluate the repeatability and validity of multiple lower limb measurements obtained using low-cost 3D limb scanning technology.

Read the 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 (ankle foot orthosis) for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).

The investigators 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 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 investigators will evaluate concurrent validity by directly comparing software-based measurements from limb scans, with direct measurements on the same individual collected using digital calipers. The investigators will determine repeatability of each technique by conducting three identical limb scans and actual physical measurements at two time points on the same day in each individual, and then comparing the results between time points. The interior of the AFO worn by participants in Group 2 will also be scanned to obtain its geometry for comparison with measurements obtained from each individual's limb.

Validity and repeatability will be assessed using measurements at multiple locations on the lower leg. 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.

Concurrent validity will be determined using the intra-class correlation coefficient and absolute error (root mean square error) for comparisons between measurements from limb scanning and the calipers. Reliability will be determined using the intra-class correlation coefficient and the minimal detectable change value for comparisons over time.

Conditions: Foot Injuries and Disorders
Being tested: Structure Sensor, Caliper
Keywords: Ankle Foot Orthosis, Adult, 3D Limb Scanning, Limb Geometry
Medical subject headings: Foot Injuries, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Structure SensorDevice
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 user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
CaliperDevice
Caliper: An OriginCal IP54 digital caliper (Anytime Inc, Granada Hills, CA) was used to take three consecutive physical measurements in millimeters at each identified measurement location. For measurements outside of the caliper's scope a tape measure was used in place of the caliper. Physical measuring devices were reset to zero between each measure.

Study groups in NCT04032041
Study group	Role	What they receive
Group 1: Healthy Able-bodied Individuals		Healthy able-bodied individuals with no history of lower extremity trauma. Receives: Device: Structure Sensor; Device: Caliper
Group 2: Individuals Requiring AFO Use		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). Receives: Device: Structure Sensor; Device: Caliper

What is being measured

The primary outcome is the main question the study is designed to answer.

Width of the Metatarsal Heads (Minimal Detectable Change [MDC])
The width of the metatarsal heads was measured as the distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intrarater-intersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Metatarsal Heads (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the width of the metatarsal heads. The width of the metatarsal heads is the distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Metatarsal Heads (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the width of the metatarsal heads. The width of the metatarsal heads is the distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Calcaneus (Minimal Detectable Change [MDC])
The width of the calcaneus was measured as the distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Calcaneus (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the width of the calcaneus. The width of the calcaneus is the distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Calcaneus (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the width of the calcaneus. The width of the calcaneus is the distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Foot Length (Minimal Detectable Change [MDC])
Foot length was measured as the distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd). Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Foot Length (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the foot length. The foot length is the distance from the the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Foot Length (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the foot length. The foot length is the distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Foot Height (Minimal Detectable Change [MDC])
Foot height was measured as the distance from the most superior point on the foot distal to the tibialis anterior insertion. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Foot Height (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the foot height. The foot height is the distance from the most superior point on the foot distal to the tibialis anterior insertion.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Foot Height (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the foot height. The foot height is the distance from the most superior point on the foot distal to the tibialis anterior insertion.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Arch Height (Minimal Detectable Change [MDC])
Arch height was measured as the dorsum height at 50% foot length. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Arch Height (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the arch height. The arch height is at 50% foot length.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Arch Height (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the arch height. The arch height is at 50% foot length.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Medial-lateral Ankle Malleoli Width (Minimal Detectable Change [MDC])
Medial-lateral ankle malleoli width was measured as the distance from the lateral malleolus to the medial malleolus. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Medial-lateral Ankle Malleoli Width (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the width of the medial-lateral ankle malleoli. The width of the medial-lateral ankle malleoli is the distance from the lateral malleolus to the medial malleolus.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Medial-lateral Ankle Malleoli Width (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the width of the medial-lateral ankle malleoli. The width of the medial-lateral ankle malleoli is the distance from the lateral malleolus to the medial malleolus.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Minimum Ankle Circumference (Minimal Detectable Change [MDC])
Minimum ankle circumference was measured as the minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Minimum Ankle Circumference (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the minimum ankle circumference. The minimum ankle circumference is the circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Minimum Ankle Circumference (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the minimum ankle circumference. The minimum ankle circumference is the circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Maximum Calf Circumference (Minimal Detectable Change [MDC])
Maximum calf circumference was measured as the maximum calf circumference greater that 5 cm distal to the knee condyles. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Maximum Calf Circumference (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the maximum calf circumference. The maximum calf circumference is the distance greater than 5 cm distal to the knee condyles.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Maximum Calf Circumference (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the maximum calf circumference. The maximum calf circumference is the distance greater than 5 cm distal to the knee condyles.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Knee Condyles (Minimal Detectable Change [MDC])
Width of the knee condyles was measured as the distance from the medial condyle to the lateral condyle. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Knee Condyles (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for the width of the knee condyles. The width of the knee condyles is the distance from the medial condyle to the lateral condyle.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Width of the Knee Condyles (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the width of the knee condyles. The width of the knee condyles is the distance from the medial condyle to the lateral condyle.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Anterior-posterior Width at Patella (Minimal Detectable Change [MDC])
Anterior-posterior width at patella was measured as the distance from mid patellar tendon to a parallel point most posterior on the back of the knee. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Anterior-posterior Width at Patella (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated for anterior-posterior width at patella. The anterior-posterior width at patella is the distance from mid patellar tendon to a parallel point most posterior on the back of the knee.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Anterior-posterior Width at Patella (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for anterior-posterior width at patella. The anterior-posterior width at patella is the distance from mid patellar tendon to a parallel point most posterior on the back of the knee.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Tibial Tubercle Height (Minimal Detectable Change [MDC])
Tibial tubercle height was measured as the distance from the floor to tibial tubercle. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession.
MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Tibial Tubercle Height (Pearson's Correlation Coefficient)
Pearson's correlation coefficient was calculated tibial tubercle height. The tibial tubercle height is the distance from the floor to tibial tubercle.
Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Tibial Tubercle Height (Mean Root Mean Square [RMS] Difference)
The mean Root Mean Square (RMS) difference was calculated for the tibial tubercle height. The tibial tubercle height is the distance from the floor to tibial tubercle.
RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)]
Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Measured: Less than 2 days
Bland-Altman Plots
Bland-Altman plot (difference plot) is a method of data plotting used in analyzing the agreement between scan and caliper measures for each identified measurements.
Measured: Less than 2 days
Intrarater-intersession ICC Values
Intrarater-intersession ICC values were calculated to determine the test-retest reliability of scanning and digital measurements, whereas inter-rater-intrasession and inter-rater-intersession ICC values were calculated to determine the reliability of digital measurements. Intrarater-intersession ICC values were calculated to determine the reliability of physical measures between sessions. ICC values generally range from 0-1 with higher values indicating better reliability
Measured: Less than 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 20195 Jul 2022

First posted25 Jul 2019
Study start27 Sep 2019
Primary completion31 Jul 2021
Study completion5 Jul 2022

Why it stopped: No participants were enrolled for group 2. Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Foot Injuries and DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04032041
Sponsor's protocol ID: 201905871
Status last verified: Nov 2024
First submitted: 22 Jul 2019
Last updated: 10 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SCANREP: Reliability of 3D Lower Limb Scanning
ClinicalTrials.gov ID: NCT04032041
Acronym / sponsor ID: 201905871
Conditions: Foot Injuries and Disorders
Keywords: Ankle Foot Orthosis, Adult, 3D Limb Scanning, Limb Geometry
Study type: Observational
Recruitment status: TerminatedReason stopped: No participants were enrolled for group 2. Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.
Enrolment: 30 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Study start: 27 Sep 2019 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 5 Jul 2022 (actual)
First posted: 25 Jul 2019 (actual)
Results: Posted 10 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Group 1: Healthy Able-bodied Individuals	–	Device: Structure Sensor, Device: CaliperHealthy able-bodied individuals with no history of lower extremity trauma.
Group 2: Individuals Requiring AFO Use	–	Device: Structure Sensor, Device: CaliperIndividuals 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Structure SensorA 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 user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.	Device	Group 1: Healthy Able-bodied Individuals, Group 2: Individuals Requiring AFO Use
CaliperCaliper: An OriginCal IP54 digital caliper (Anytime Inc, Granada Hills, CA) was used to take three consecutive physical measurements in millimeters at each identified measurement location. For measurements outside of the caliper's scope a tape measure was used in place of the caliper. Physical measuring devices were reset to zero between each measure.	Device	Group 1: Healthy Able-bodied Individuals, Group 2: Individuals Requiring AFO Use

Primary outcome

Width of the Metatarsal Heads (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
The width of the metatarsal heads was measured as the distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intrarater-intersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Metatarsal Heads (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the width of the metatarsal heads. The width of the metatarsal heads is the distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Metatarsal Heads (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the width of the metatarsal heads. The width of the metatarsal heads is the distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Calcaneus (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
The width of the calcaneus was measured as the distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Calcaneus (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the width of the calcaneus. The width of the calcaneus is the distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Calcaneus (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the width of the calcaneus. The width of the calcaneus is the distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Foot Length (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Foot length was measured as the distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd). Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Foot Length (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the foot length. The foot length is the distance from the the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd). Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Foot Length (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the foot length. The foot length is the distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd). RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Foot Height (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Foot height was measured as the distance from the most superior point on the foot distal to the tibialis anterior insertion. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Foot Height (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the foot height. The foot height is the distance from the most superior point on the foot distal to the tibialis anterior insertion. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Foot Height (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the foot height. The foot height is the distance from the most superior point on the foot distal to the tibialis anterior insertion. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Arch Height (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Arch height was measured as the dorsum height at 50% foot length. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Arch Height (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the arch height. The arch height is at 50% foot length. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Arch Height (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the arch height. The arch height is at 50% foot length. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Medial-lateral Ankle Malleoli Width (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Medial-lateral ankle malleoli width was measured as the distance from the lateral malleolus to the medial malleolus. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Medial-lateral Ankle Malleoli Width (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the width of the medial-lateral ankle malleoli. The width of the medial-lateral ankle malleoli is the distance from the lateral malleolus to the medial malleolus. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Medial-lateral Ankle Malleoli Width (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the width of the medial-lateral ankle malleoli. The width of the medial-lateral ankle malleoli is the distance from the lateral malleolus to the medial malleolus. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Minimum Ankle Circumference (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Minimum ankle circumference was measured as the minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Minimum Ankle Circumference (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the minimum ankle circumference. The minimum ankle circumference is the circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Minimum Ankle Circumference (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the minimum ankle circumference. The minimum ankle circumference is the circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Maximum Calf Circumference (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Maximum calf circumference was measured as the maximum calf circumference greater that 5 cm distal to the knee condyles. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Maximum Calf Circumference (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the maximum calf circumference. The maximum calf circumference is the distance greater than 5 cm distal to the knee condyles. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Maximum Calf Circumference (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the maximum calf circumference. The maximum calf circumference is the distance greater than 5 cm distal to the knee condyles. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Knee Condyles (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Width of the knee condyles was measured as the distance from the medial condyle to the lateral condyle. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Knee Condyles (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for the width of the knee condyles. The width of the knee condyles is the distance from the medial condyle to the lateral condyle. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Width of the Knee Condyles (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the width of the knee condyles. The width of the knee condyles is the distance from the medial condyle to the lateral condyle. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Anterior-posterior Width at Patella (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Anterior-posterior width at patella was measured as the distance from mid patellar tendon to a parallel point most posterior on the back of the knee. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Anterior-posterior Width at Patella (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated for anterior-posterior width at patella. The anterior-posterior width at patella is the distance from mid patellar tendon to a parallel point most posterior on the back of the knee. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Anterior-posterior Width at Patella (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for anterior-posterior width at patella. The anterior-posterior width at patella is the distance from mid patellar tendon to a parallel point most posterior on the back of the knee. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Tibial Tubercle Height (Minimal Detectable Change [MDC])
Time frame: Less than 2 days
Tibial tubercle height was measured as the distance from the floor to tibial tubercle. Reliability of these measures was assessed using minimal detectable change (MDC) values. MDC values are in the same units as the original measure, and smaller values are better. Minimal Detectable Change (MDC) values are presented for: caliper intraraterintersession, scan intrarater-intersession, scan interrater-intrasession, and scan interrater-intersession. MDCs were calculated for all participants as a whole using the equation SEM x 1.96 x SQRT where SEM was calculated using the equation SD x SQRT (1-ICC), where SD is the pooled variance. ICC values were calculated using SPSS v.25 using model (2,k). [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Tibial Tubercle Height (Pearson's Correlation Coefficient)
Time frame: Less than 2 days
Pearson's correlation coefficient was calculated tibial tubercle height. The tibial tubercle height is the distance from the floor to tibial tubercle. Pearson product-moment correlations were calculated for all participants as a whole to compare between caliper and scan measurements using the function PEARSON (array1, array2) and categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation. [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Tibial Tubercle Height (Mean Root Mean Square [RMS] Difference)
Time frame: Less than 2 days
The mean Root Mean Square (RMS) difference was calculated for the tibial tubercle height. The tibial tubercle height is the distance from the floor to tibial tubercle. RMS was calculated by squaring the mean for all participants, adding up the squares (which are all positive) and dividing by the number of samples to find the average square or mean square, then taking the square root of that. And the root mean square difference was calculated by comparing caliper and scan measurements [Powers OA, et al. (2022), Prosthet Orthot Int. 46(1)] Data is only presented for group 1 as study activities related to group 2 were terminated due to the COVID pandemic.
Bland-Altman Plots
Time frame: Less than 2 days
Bland-Altman plot (difference plot) is a method of data plotting used in analyzing the agreement between scan and caliper measures for each identified measurements.
Intrarater-intersession ICC Values
Time frame: Less than 2 days
Intrarater-intersession ICC values were calculated to determine the test-retest reliability of scanning and digital measurements, whereas inter-rater-intrasession and inter-rater-intersession ICC values were calculated to determine the reliability of digital measurements. Intrarater-intersession ICC values were calculated to determine the reliability of physical measures between sessions. ICC values generally range from 0-1 with higher values indicating better reliability

Results and safety

Results posted to the registry on 10 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Healthy Able-Bodied Individuals	30	30
Group 2: Individuals Requiring AFO Use	0	0

Primary outcome: Width of the Metatarsal Heads (Minimal Detectable Change [MDC])

Time frame: Less than 2 days. Number. Unit: mm

Measure	Group 1: Healthy Able-Bodied Individuals n = 30	Group 2: Individuals Requiring AFO Use n = 0
Caliper intrarater intersession	1.1	–
Scan intrarater intersession	2.8	–
Scan interrater intrasession	2.2	–
Scan interrater intersession	3.1	–

Population analysed: No participants were enrolled for group 2 (individuals requiring AFO use). Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.

Primary outcome: Width of the Metatarsal Heads (Pearson's Correlation Coefficient)

Time frame: Less than 2 days. Number. Unit: correlation coefficient

Measure	Group 1: Healthy Able-Bodied Individuals n = 30	Group 2: Individuals Requiring AFO Use n = 0
Value	0.93	–

Population analysed: Pearson's correlation coefficient values were calculated to compare between caliper and scan measurements. Pearson product-moment correlations were categorized based on the scale of negligible (0-0.30), low (0.30-0.50), moderate (0.50-0.70), high (0.70-0.90), and very high (0.90-1.0) correlation.

Primary outcome: Width of the Metatarsal Heads (Mean Root Mean Square [RMS] Difference)

Time frame: Less than 2 days. Number. Unit: mm

Measure	Group 1: Healthy Able-Bodied Individuals n = 30	Group 2: Individuals Requiring AFO Use n = 0
Value	2.4	–

Population analysed: RMS difference values were calculated to compare between caliper and scan measurements.

Primary outcome: Width of the Calcaneus (Minimal Detectable Change [MDC])

Time frame: Less than 2 days. Number. Unit: mm

Measure	Group 1: Healthy Able-Bodied Individuals n = 30	Group 2: Individuals Requiring AFO Use n = 0
Caliper intrarater intersession	0.8	–
Scan intrarater intersession	2.8	–
Scan interrater intrasession	1.1	–
Scan interrater intersession	3.0	–

Adverse events

Time frame: Adverse events were monitored/assessed before starting study activities and after each round of measurement (caliper/scan) during the study visit (~1 hour). Monitoring stopped at the end of the study visit but participants were instructed to contact the research team and report adverse events following the study visit, up to a maximum of 12 months post study completion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Healthy Able-bodied Individuals (Completed)	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Group 2: Individuals Requiring AFO Use (Completed)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): No participants were enrolled for group 2 (individuals requiring AFO use). Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason M Wilken, PT, PhD principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Foot Injuries and Disorders, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Width of the Metatarsal Heads (Minimal Detectable Change [MDC]) (time frame: Less than 2 days). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04032041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.