Trial Outcomes & Findings for SCANREP: Reliability of 3D Lower Limb Scanning (NCT NCT04032041)

NCT ID: NCT04032041

Last Updated: 2025-01-10

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 30 participants
• Primary outcome timeframe: Less than 2 days
• Results posted on: 2025-01-10

Participant Flow

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.

Participant milestones

Measure	Group 1: Healthy Able-Bodied Individuals Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.
Overall Study STARTED	30	0
Overall Study COMPLETED	30	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants	0 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	0 Participants	0 Participants n=30 Participants
Age, Continuous	34.9 years STANDARD_DEVIATION 16 • n=30 Participants	—	34.9 years STANDARD_DEVIATION 16 • n=30 Participants
Sex: Female, Male Female	17 Participants n=30 Participants	—	17 Participants n=30 Participants
Sex: Female, Male Male	13 Participants n=30 Participants	—	13 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Metatarsal Heads (Minimal Detectable Change [MDC]) Caliper intrarater intersession	1.1 mm	—	—	—
Width of the Metatarsal Heads (Minimal Detectable Change [MDC]) Scan intrarater intersession	2.8 mm	—	—	—
Width of the Metatarsal Heads (Minimal Detectable Change [MDC]) Scan interrater intrasession	2.2 mm	—	—	—
Width of the Metatarsal Heads (Minimal Detectable Change [MDC]) Scan interrater intersession	3.1 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Metatarsal Heads (Pearson's Correlation Coefficient)	0.93 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Metatarsal Heads (Mean Root Mean Square [RMS] Difference)	2.4 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Calcaneus (Minimal Detectable Change [MDC]) Caliper intrarater intersession	0.8 mm	—	—	—
Width of the Calcaneus (Minimal Detectable Change [MDC]) Scan intrarater intersession	2.8 mm	—	—	—
Width of the Calcaneus (Minimal Detectable Change [MDC]) Scan interrater intrasession	1.1 mm	—	—	—
Width of the Calcaneus (Minimal Detectable Change [MDC]) Scan interrater intersession	3.0 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Calcaneus (Pearson's Correlation Coefficient)	0.93 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Calcaneus (Mean Root Mean Square [RMS] Difference)	4.2 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Foot Length (Minimal Detectable Change [MDC]) Caliper intrarater intersession	1.5 mm	—	—	—
Foot Length (Minimal Detectable Change [MDC]) Scan interrater intrasession	2.3 mm	—	—	—
Foot Length (Minimal Detectable Change [MDC]) Scan interrater intersession	4.3 mm	—	—	—
Foot Length (Minimal Detectable Change [MDC]) Scan intrarater intersession	3.2 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Foot Length (Pearson's Correlation Coefficient)	.99 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Foot Length (Mean Root Mean Square [RMS] Difference)	3.0 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Foot Height (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	2.1 mm	—	—	—
Foot Height (Minimal Detectable Change [MDC]) Scan intrarater intersession	2.8 mm	—	—	—
Foot Height (Minimal Detectable Change [MDC]) Scan Interrater intrasession	4.9 mm	—	—	—
Foot Height (Minimal Detectable Change [MDC]) Scan Interrater intersession	5.9 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Foot Height (Pearson's Correlation Coefficient)	.8 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Foot Height (Mean Root Mean Square [RMS] Difference)	3.4 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Arch Height (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	2.3 mm	—	—	—
Arch Height (Minimal Detectable Change [MDC]) Scan intrarater intersession	3.6 mm	—	—	—
Arch Height (Minimal Detectable Change [MDC]) Scan Interrater intrasession	3.4 mm	—	—	—
Arch Height (Minimal Detectable Change [MDC]) Scan Interrater intersession	5.8 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Arch Height (Pearson's Correlation Coefficient)	.85 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Arch Height (Mean Root Mean Square [RMS] Difference)	3.2 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Medial-lateral Ankle Malleoli Width (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	1.0 mm	—	—	—
Medial-lateral Ankle Malleoli Width (Minimal Detectable Change [MDC]) Scan intrarater intersession	2.6 mm	—	—	—
Medial-lateral Ankle Malleoli Width (Minimal Detectable Change [MDC]) Scan Interrater intrasession	1.2 mm	—	—	—
Medial-lateral Ankle Malleoli Width (Minimal Detectable Change [MDC]) Scan Interrater intersession	2.7 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Medial-lateral Ankle Malleoli Width (Pearson's Correlation Coefficient)	.87 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Medial-lateral Ankle Malleoli Width (Mean Root Mean Square [RMS] Difference)	2.8 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Minimum Ankle Circumference (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	1.4 mm	—	—	—
Minimum Ankle Circumference (Minimal Detectable Change [MDC]) Scan intrarater intersession MDC Scan intrarater intersession	7.5 mm	—	—	—
Minimum Ankle Circumference (Minimal Detectable Change [MDC]) Scan Interrater intrasession	1.6 mm	—	—	—
Minimum Ankle Circumference (Minimal Detectable Change [MDC]) Scan Interrater intersession	8.1 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Minimum Ankle Circumference (Pearson's Correlation Coefficient)	0.93 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Minimum Ankle Circumference (Mean Root Mean Square [RMS] Difference)	8.7 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Maximum Calf Circumference (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	4.3 mm	—	—	—
Maximum Calf Circumference (Minimal Detectable Change [MDC]) Scan intrarater intersession	5.4 mm	—	—	—
Maximum Calf Circumference (Minimal Detectable Change [MDC]) Scan Interrater intrasession	2.2 mm	—	—	—
Maximum Calf Circumference (Minimal Detectable Change [MDC]) Scan Interrater intersession	5.8 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Maximum Calf Circumference (Pearson's Correlation Coefficient)	.96 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Maximum Calf Circumference (Mean Root Mean Square [RMS] Difference)	7.2 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Knee Condyles (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	3.4 mm	—	—	—
Width of the Knee Condyles (Minimal Detectable Change [MDC]) Scan intrarater intersession	4.2 mm	—	—	—
Width of the Knee Condyles (Minimal Detectable Change [MDC]) Scan Interrater intrasession	1.4 mm	—	—	—
Width of the Knee Condyles (Minimal Detectable Change [MDC]) Scan Interrater intersession	4.2 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Knee Condyles (Pearson's Correlation Coefficient)	.98 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Width of the Knee Condyles (Mean Root Mean Square [RMS] Difference)	3.9 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Anterior-posterior Width at Patella (Minimal Detectable Change [MDC]) Scan Interrater intersession	3.7 mm	—	—	—
Anterior-posterior Width at Patella (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	4.8 mm	—	—	—
Anterior-posterior Width at Patella (Minimal Detectable Change [MDC]) Scan intrarater intersession	3.7 mm	—	—	—
Anterior-posterior Width at Patella (Minimal Detectable Change [MDC]) Scan Interrater intrasession	1.5 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Anterior-posterior Width at Patella (Pearson's Correlation Coefficient)	0.93 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Anterior-posterior Width at Patella (Mean Root Mean Square [RMS] Difference)	6.0 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Tibial Tubercle Height (Minimal Detectable Change [MDC]) Caliper Intrarater intersession	3.6 mm	—	—	—
Tibial Tubercle Height (Minimal Detectable Change [MDC]) Scan intrarater intersession	5.2 mm	—	—	—
Tibial Tubercle Height (Minimal Detectable Change [MDC]) Scan Interrater intrasession	6.3 mm	—	—	—
Tibial Tubercle Height (Minimal Detectable Change [MDC]) Scan Interrater intersession	7.9 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Tibial Tubercle Height (Pearson's Correlation Coefficient)	.97 correlation coefficient	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

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

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Tibial Tubercle Height (Mean Root Mean Square [RMS] Difference)	5.8 mm	—	—	—

PRIMARY outcome

Timeframe: Less than 2 days

Population: 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.

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.

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	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). 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. Scan: 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.	Scan Inter-rater-intrasession Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession Healthy able-bodied individuals with no history of lower extremity trauma.
Bland-Altman Plots Maximum calf circumference	-2.14 mm Standard Deviation 4.13	—	—	—
Bland-Altman Plots Width of metatarsal heads	-0.09 mm Standard Deviation 1.68	—	—	—
Bland-Altman Plots Width of calcaneus	-3.50 mm Standard Deviation 2.21	—	—	—
Bland-Altman Plots Foot height	1.16 mm Standard Deviation 2.49	—	—	—
Bland-Altman Plots Medial arch height	1.01 mm Standard Deviation 2.14	—	—	—
Bland-Altman Plots Medial-lateral width between ankle malleoli	-1.59 mm Standard Deviation 1.68	—	—	—
Bland-Altman Plots Foot length	-1.37 mm Standard Deviation 1.73	—	—	—
Bland-Altman Plots Minimum circumference above the ankle malleoli	-5.78 mm Standard Deviation 5.73	—	—	—
Bland-Altman Plots Medial-lateral width of the knee condyles	-2.99 mm Standard Deviation 2.27	—	—	—
Bland-Altman Plots Anterior-posterior width at mid patellar tendon	-4.46 mm Standard Deviation 3.23	—	—	—
Bland-Altman Plots Distance from bottom of foot to tibial tubercle	-1.41 mm Standard Deviation 3.99	—	—	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Group 1: Healthy Able-Bodied Individuals n=30 Participants Healthy able-bodied individuals with no history of traumatic lower limb injury. 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. Scan: 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.	Group 2: Individuals Requiring AFO Use n=30 Participants 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). 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. Scan: 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.	Scan Inter-rater-intrasession n=30 Participants Healthy able-bodied individuals with no history of lower extremity trauma.	Scan Inter-rater Intersession n=30 Participants Healthy able-bodied individuals with no history of lower extremity trauma.
Intrarater-intersession ICC Values Width of metatarsal heads	0.99 correlation coefficient Interval 0.99 to 0.99	0.98 correlation coefficient Interval 0.95 to 0.99	0.99 correlation coefficient Interval 0.97 to 0.99	0.97 correlation coefficient Interval 0.94 to 0.99
Intrarater-intersession ICC Values Width of calcaneus	0.99 correlation coefficient Interval 0.99 to 1.0	0.98 correlation coefficient Interval 0.95 to 0.99	0.99 correlation coefficient Interval 0.99 to 0.99	0.97 correlation coefficient Interval 0.94 to 0.99
Intrarater-intersession ICC Values Foot height	0.97 correlation coefficient Interval 0.94 to 0.99	0.97 correlation coefficient Interval 0.93 to 0.98	0.89 correlation coefficient Interval 0.77 to 0.95	0.84 correlation coefficient Interval 0.67 to 0.92
Intrarater-intersession ICC Values Arch height	0.98 correlation coefficient Interval 0.96 to 0.99	0.94 correlation coefficient Interval 0.88 to 0.97	0.95 correlation coefficient Interval 0.9 to 0.98	0.85 correlation coefficient Interval 0.68 to 0.93
Intrarater-intersession ICC Values Medial-lateral width between ankle malleoli	0.99 correlation coefficient Interval 0.99 to 1.0	0.96 correlation coefficient Interval 0.92 to 0.98	0.99 correlation coefficient Interval 0.98 to 0.99	0.96 correlation coefficient Interval 0.91 to 0.98
Intrarater-intersession ICC Values Foot length	0.99 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.98 to 0.99
Intrarater-intersession ICC Values Minimum circumference above the ankle malleoli	0.99 correlation coefficient Interval 0.99 to 1.0	0.98 correlation coefficient Interval 0.95 to 0.99	0.99 correlation coefficient Interval 0.99 to 1.0	0.97 correlation coefficient Interval 0.94 to 0.99
Intrarater-intersession ICC Values Maximum calf circumference	0.99 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.98 to 0.99	1.00 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.98 to 0.99
Intrarater-intersession ICC Values Medial-lateral width of the knee condyles	0.99 correlation coefficient Interval 0.97 to 0.99	0.98 correlation coefficient Interval 0.96 to 0.99	0.99 correlation coefficient Interval 0.99 to 1.0	0.98 correlation coefficient Interval 0.96 to 0.99
Intrarater-intersession ICC Values Anterior-posterior width at mid patellar tendon	0.96 correlation coefficient Interval 0.92 to 0.98	0.98 correlation coefficient Interval 0.96 to 0.99	0.99 correlation coefficient Interval 0.99 to 1.0	0.98 correlation coefficient Interval 0.96 to 0.99
Intrarater-intersession ICC Values Distance from bottom of foot to tibial tubercle	0.99 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.99 to 1.0	0.99 correlation coefficient Interval 0.98 to 0.99	0.99 correlation coefficient Interval 0.97 to 0.99

Adverse Events

Group 1: Healthy Able-bodied Individuals (Completed)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2: Individuals Requiring AFO Use (Completed)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason M Wilken, PT, PhD

University of Iowa

Phone: 319-335-9791

Email: jason-wilken@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place