Flat Feet, High Arched Foot
Conditions
Brief summary
The goal of this project is to validate a new non-invasive clinical imaging system to evaluate the efficacy of plantar orthotics and to assess the biomechanical efficiency of plantar orthotics for people with flat or high arch feet. The Cryovizion system should detect changes in participants' posture with an accuracy of 95%, while orthotics should improve the body's postural symmetry index.
Interventions
DEVICEFoot orthosis for flat feet
Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.
DEVICEFoot 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.
Sponsors
Cryos Technologies Inc.
Natural Sciences and Engineering Research Council, Canada
TOPMED
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI\<30 * No pain * No musculoskeletal disorders * No balance disorders * No pathologies linked to the central nervous system * No use of drugs affecting the balance
Exclusion criteria
* People with foot pathology other than the arch; * People with diabetes ; * People with severe obesity ; * People wearing high heel shoes regularly ; * People with degenerative disease ; * People with neuromuscular pathology ; * People with a circulatory disorder ; * People who have had major lower body surgery; * Inability to walk 30 minutes continuously.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months | Baseline and 2 months | 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. |
| Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months | Baseline and 6 months | 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. |
| Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months | Baseline and 12 months | 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. |
| Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months | Change between directly after 2 months of intervention and baseline values | 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. |
| Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months | Change between directly after 6 months of intervention and baseline values | 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. |
| Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months | Change between directly after 12 months of intervention and baseline values | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 11 |
| 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. | 20 |
| Total | 65 |
Baseline characteristics
| Characteristic | Flat Feet | High Arches Feet | Normal Arches Feet (Control Group) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 11 Participants | 20 Participants | 65 Participants |
| Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics Ankle asymmetry | 2.72 degrees STANDARD_DEVIATION 1.43 | 4.41 degrees STANDARD_DEVIATION 3.06 | 3.77 degrees STANDARD_DEVIATION 3.11 | 3.34 degrees STANDARD_DEVIATION 2.46 |
| Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics Hip asymmetry | 1.84 degrees STANDARD_DEVIATION 0.94 | 1.90 degrees STANDARD_DEVIATION 1.16 | 1.95 degrees STANDARD_DEVIATION 0.98 | 1.89 degrees STANDARD_DEVIATION 0.98 |
| Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics Knee asymmetry | 2.97 degrees STANDARD_DEVIATION 1.27 | 3.14 degrees STANDARD_DEVIATION 1.76 | 3.09 degrees STANDARD_DEVIATION 1.62 | 3.04 degrees STANDARD_DEVIATION 1.47 |
| Body's postural symmetry index | 0.348 units on a scale STANDARD_DEVIATION 0.037 | 0.411 units on a scale STANDARD_DEVIATION 0.046 | 0.358 units on a scale STANDARD_DEVIATION 0.039 | 0.361 units on a scale STANDARD_DEVIATION 0.039 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 11 Participants | 20 Participants | 65 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 34 participants | 11 participants | 20 participants | 65 participants |
| Sex: Female, Male Female | 26 Participants | 7 Participants | 13 Participants | 46 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 7 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 11 | 0 / 20 |
| other Total, other adverse events | 4 / 34 | 4 / 11 | 0 / 20 |
| serious Total, serious adverse events | 0 / 34 | 0 / 11 | 0 / 20 |
Outcome results
Primary
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months
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.
Time frame: Change between directly after 12 months of intervention and baseline values
Population: Participants who completed the overall study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Flat Feet | 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 1.1 |
| Experimental: Flat Feet | 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 |
| Experimental: Flat Feet | 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 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months | Hip asymmetry | 0.28 degrees | Standard Deviation 0.6 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months | Knee asymmetry | 0.47 degrees | Standard Deviation 1.05 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months | Ankle asymmetry | 0.92 degrees | Standard Deviation 1.87 |
Primary
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months
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.
Time frame: Change between directly after 2 months of intervention and baseline values
Population: Participants who completed the overall study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Flat Feet | 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 |
| Experimental: Flat Feet | 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 |
| Experimental: Flat Feet | 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 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months | Hip asymmetry | 0.41 degrees | Standard Deviation 0.33 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months | Knee asymmetry | 0.33 degrees | Standard Deviation 0.81 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months | Ankle asymmetry | 0.28 degrees | Standard Deviation 1.85 |
Primary
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months
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.
Time frame: Change between directly after 6 months of intervention and baseline values
Population: Participants who completed the overall study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental: Flat Feet | 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 |
| Experimental: Flat Feet | 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 |
| Experimental: Flat Feet | 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 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months | Hip asymmetry | 0.43 degrees | Standard Deviation 0.51 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months | Knee asymmetry | 0.37 degrees | Standard Deviation 1.59 |
| Experimental: High Arches Feet | Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months | Ankle asymmetry | 0.18 degrees | Standard Deviation 1 |
Primary
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months
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.
Time frame: Baseline and 12 months
Population: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Flat Feet | Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months | 0.041 score on a scale | Standard Deviation 0.079 |
| Experimental: High Arches Feet | Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months | 0.006 score on a scale | Standard Deviation 0.057 |
Primary
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months
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.
Time frame: Baseline and 2 months
Population: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Flat Feet | Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months | -0.031 score on a scale | Standard Deviation 0.054 |
| Experimental: High Arches Feet | Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months | 0.010 score on a scale | Standard Deviation 0.061 |
Primary
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months
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.
Time frame: Baseline and 6 months
Population: The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: Flat Feet | Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months | 0.020 score on a scale | Standard Deviation 0.07 |
| Experimental: High Arches Feet | Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months | -0.016 score on a scale | Standard Deviation 0.076 |