Trial Outcomes & Findings for Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System (NCT NCT05163418)

Last Updated: 2025-07-30

Results Overview

Change in body's postural symmetry index(SSIM gray) at 2 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

Baseline and 2 months

Results posted on

2025-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Flat Feet People with flat feet according to foot posture index (validated by clinical assessment) Foot orthoses for high arches feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	High Arches Feet People with high arches feet according to foot posture index (validated by clinical assessment) Foot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	Normal Arches Feet (Control Group) Control group
Overall Study STARTED	34	11	20
Overall Study COMPLETED	23	7	20
Overall Study NOT COMPLETED	11	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flat Feet n=34 Participants People with flat feet according to foot posture index (validated by clinical assessment) Foot orthoses for high arches feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	High Arches Feet n=11 Participants People with high arches feet according to foot posture index (validated by clinical assessment) Foot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	Normal Arches Feet (Control Group) n=20 Participants Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants	65 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants	46 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants	65 Participants n=4 Participants
Region of Enrollment Canada	34 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants	65 participants n=4 Participants
Body's postural symmetry index	0.348 units on a scale STANDARD_DEVIATION 0.037 • n=5 Participants	0.411 units on a scale STANDARD_DEVIATION 0.046 • n=7 Participants	0.358 units on a scale STANDARD_DEVIATION 0.039 • n=5 Participants	0.361 units on a scale STANDARD_DEVIATION 0.039 • n=4 Participants
Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics Hip asymmetry	1.84 degrees STANDARD_DEVIATION 0.94 • n=5 Participants	1.90 degrees STANDARD_DEVIATION 1.16 • n=7 Participants	1.95 degrees STANDARD_DEVIATION 0.98 • n=5 Participants	1.89 degrees STANDARD_DEVIATION 0.98 • n=4 Participants
Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics Knee asymmetry	2.97 degrees STANDARD_DEVIATION 1.27 • n=5 Participants	3.14 degrees STANDARD_DEVIATION 1.76 • n=7 Participants	3.09 degrees STANDARD_DEVIATION 1.62 • n=5 Participants	3.04 degrees STANDARD_DEVIATION 1.47 • n=4 Participants
Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics Ankle asymmetry	2.72 degrees STANDARD_DEVIATION 1.43 • n=5 Participants	4.41 degrees STANDARD_DEVIATION 3.06 • n=7 Participants	3.77 degrees STANDARD_DEVIATION 3.11 • n=5 Participants	3.34 degrees STANDARD_DEVIATION 2.46 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 2 months

Population: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.

Outcome measures

Outcome measures
Measure	Experimental: Flat Feet n=22 Participants People with flat feet according to foot posture index 6 (validated by clinical assessment)	Experimental: High Arches Feet n=7 Participants People with high arches feet according to foot posture index 6 (validated by clinical assessment)	Normal Arches Feet (Control Group) Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months	-0.031 score on a scale Standard Deviation 0.054	0.010 score on a scale Standard Deviation 0.061	—

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.

Change in body's postural symmetry index(SSIM gray) at 6 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.

Outcome measures

Outcome measures
Measure	Experimental: Flat Feet n=22 Participants People with flat feet according to foot posture index 6 (validated by clinical assessment)	Experimental: High Arches Feet n=7 Participants People with high arches feet according to foot posture index 6 (validated by clinical assessment)	Normal Arches Feet (Control Group) Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months	0.020 score on a scale Standard Deviation 0.070	-0.016 score on a scale Standard Deviation 0.076	—

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.

Change in body's postural symmetry index(SSIM gray) at 12 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.

Outcome measures

Outcome measures
Measure	Experimental: Flat Feet n=22 Participants People with flat feet according to foot posture index 6 (validated by clinical assessment)	Experimental: High Arches Feet n=7 Participants People with high arches feet according to foot posture index 6 (validated by clinical assessment)	Normal Arches Feet (Control Group) Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months	0.041 score on a scale Standard Deviation 0.079	0.006 score on a scale Standard Deviation 0.057	—

PRIMARY outcome

Timeframe: Change between directly after 2 months of intervention and baseline values

Population: Participants who completed the overall study.

Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 2 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Outcome measures

Outcome measures
Measure	Experimental: Flat Feet n=23 Participants People with flat feet according to foot posture index 6 (validated by clinical assessment)	Experimental: High Arches Feet n=7 Participants People with high arches feet according to foot posture index 6 (validated by clinical assessment)	Normal Arches Feet (Control Group) Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months Hip asymmetry	0.04 degrees Standard Deviation 0.97	0.41 degrees Standard Deviation 0.33	—
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months Knee asymmetry	0.14 degrees Standard Deviation 1.67	0.33 degrees Standard Deviation 0.81	—
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months Ankle asymmetry	0.20 degrees Standard Deviation 1.72	0.28 degrees Standard Deviation 1.85	—

PRIMARY outcome

Timeframe: Change between directly after 6 months of intervention and baseline values

Population: Participants who completed the overall study.

Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 6 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Outcome measures

Outcome measures
Measure	Experimental: Flat Feet n=23 Participants People with flat feet according to foot posture index 6 (validated by clinical assessment)	Experimental: High Arches Feet n=7 Participants People with high arches feet according to foot posture index 6 (validated by clinical assessment)	Normal Arches Feet (Control Group) Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months Hip asymmetry	0.09 degrees Standard Deviation 0.91	0.43 degrees Standard Deviation 0.51	—
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months Knee asymmetry	0.27 degrees Standard Deviation 1.68	0.37 degrees Standard Deviation 1.59	—
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months Ankle asymmetry	0.79 degrees Standard Deviation 1.81	0.18 degrees Standard Deviation 1.00	—

PRIMARY outcome

Timeframe: Change between directly after 12 months of intervention and baseline values

Population: Participants who completed the overall study.

Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 12 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.

Outcome measures

Outcome measures
Measure	Experimental: Flat Feet n=23 Participants People with flat feet according to foot posture index 6 (validated by clinical assessment)	Experimental: High Arches Feet n=7 Participants People with high arches feet according to foot posture index 6 (validated by clinical assessment)	Normal Arches Feet (Control Group) Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months Hip asymmetry	-0.02 degrees Standard Deviation 1.10	0.28 degrees Standard Deviation 0.60	—
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months Knee asymmetry	0.10 degrees Standard Deviation 0.94	0.47 degrees Standard Deviation 1.05	—
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months Ankle asymmetry	-0.14 degrees Standard Deviation 1.16	0.92 degrees Standard Deviation 1.87	—

Adverse Events

Flat Feet

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

High Arches Feet

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Normal Arches Feet (Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flat Feet n=34 participants at risk People with flat feet according to foot posture index (validated by clinical assessment) Foot orthoses for high arches feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	High Arches Feet n=11 participants at risk People with high arches feet according to foot posture index (validated by clinical assessment) Foot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.	Normal Arches Feet (Control Group) n=20 participants at risk Control group
Musculoskeletal and connective tissue disorders Foot pain	11.8% 4/34 • Number of events 5 • Adverse event data was collected from baseline to 12 months visit for the groups with treatment(flat and high arches feet). No follow-up was done with the normal feet group therefore adverse event data was only collected for baseline visit.	36.4% 4/11 • Number of events 4 • Adverse event data was collected from baseline to 12 months visit for the groups with treatment(flat and high arches feet). No follow-up was done with the normal feet group therefore adverse event data was only collected for baseline visit.	0.00% 0/20 • Adverse event data was collected from baseline to 12 months visit for the groups with treatment(flat and high arches feet). No follow-up was done with the normal feet group therefore adverse event data was only collected for baseline visit.

Additional Information

Edith Martin

Topmed

Phone: 418 683-2104

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is 1 year from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER