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| Name | Class |
|---|---|
| Cryos Technologies Inc. | UNKNOWN |
| Natural Sciences and Engineering Research Council, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flat feet | Experimental | People with flat feet according to foot posture index (validated by clinical assessment) |
|
| High arches feet | Experimental | People with high arches feet according to foot posture index (validated by clinical assessment) |
|
| Normal arches feet (control group) | No Intervention | Control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot orthosis for flat feet | Device | Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 2 months |
| 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. | Baseline and 6 months |
| 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. | Baseline and 12 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edith Martin, PhD | TOPMED | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOPMED | Québec | Quebec | G1S1C1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Normal Arches Feet (Control Group) | Control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | High Arches Feet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 2 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Foot pain directly associated with the foot orthoses during treatment. |
Target number of participants needed to achieve target power was not reached for all groups. Drop outs were not evenly distributed in between groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edith Martin | Topmed | 418 683-2104 | 1302 | emartin@topmed.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 26, 2025 | Jun 26, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2025 | Jun 26, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| D000070589 | Talipes Cavus |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D061826 | Foot Orthoses |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Foot orthoses for high arches feet | Device | Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics. |
|
| Change between directly after 2 months of intervention and baseline values |
| 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. | Change between directly after 6 months of intervention and baseline values |
| 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. | Change between directly after 12 months of intervention and baseline values |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body's postural symmetry index | Body's postural symmetry index(SSIM gray) at baseline. 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. | Mean | Standard Deviation | units on a scale |
|
| Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics | Absolute asymmetry values of flexion/extension angle of lower body joints during gait without foot orthotics. 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. | Mean | Standard Deviation | degrees |
|
| Experimental: High Arches Feet |
People with high arches feet according to foot posture index 6 (validated by clinical assessment) |
| OG002 | 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. |
|
|
| 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. | The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
|
|
| 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. | The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 months |
|
|
|
| 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. | Participants who completed the overall study. | Posted | Mean | Standard Deviation | degrees | Change between directly after 2 months of intervention and baseline values |
|
|
|
| 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. | Participants who completed the overall study. | Posted | Mean | Standard Deviation | degrees | Change between directly after 6 months of intervention and baseline values |
|
|
|
| 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. | Participants who completed the overall study. | Posted | Mean | Standard Deviation | degrees | Change between directly after 12 months of intervention and baseline values |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 4 |
| 34 |
| EG001 | 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. | 0 | 11 | 0 | 11 | 4 | 11 |
| EG002 | Normal Arches Feet (Control Group) | Control group | 0 | 20 | 0 | 20 | 0 | 20 |
|
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.
| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Ankle asymmetry |
|
| Ankle asymmetry |
|
| Ankle asymmetry |
|