Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05163418
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2021-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005413', 'term': 'Flatfoot'}, {'id': 'D000070589', 'term': 'Talipes Cavus'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061826', 'term': 'Foot Orthoses'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emartin@topmed.ca', 'phone': '418 683-2104', 'title': 'Edith Martin', 'phoneExt': '1302', 'organization': 'Topmed'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Target number of participants needed to achieve target power was not reached for all groups. Drop outs were not evenly distributed in between groups.'}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Flat Feet', 'description': 'People with flat feet according to foot posture index (validated by clinical assessment)\n\nFoot 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.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 4, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Arches Feet', 'description': 'People with high arches feet according to foot posture index (validated by clinical assessment)\n\nFoot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Foot pain', 'notes': 'Foot pain directly associated with the foot orthoses during treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Flat Feet', 'description': 'People with flat feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG001', 'title': 'Experimental: High Arches Feet', 'description': 'People with high arches feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.031', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.061', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 months', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Flat Feet', 'description': 'People with flat feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG001', 'title': 'Experimental: High Arches Feet', 'description': 'People with high arches feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.020', 'spread': '0.070', 'groupId': 'OG000'}, {'value': '-0.016', 'spread': '0.076', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months", 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Flat Feet', 'description': 'People with flat feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG001', 'title': 'Experimental: High Arches Feet', 'description': 'People with high arches feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.041', 'spread': '0.079', 'groupId': 'OG000'}, {'value': '0.006', 'spread': '0.057', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months', 'description': "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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The normal arches control group only completed the baseline visit, therefore change from baseline outcome measures are not reported.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Flat Feet', 'description': 'People with flat feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG001', 'title': 'Experimental: High Arches Feet', 'description': 'People with high arches feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}], 'classes': [{'title': 'Hip asymmetry', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Knee asymmetry', 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Ankle asymmetry', 'categories': [{'measurements': [{'value': '0.20', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '1.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between directly after 2 months of intervention and baseline values', 'description': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the overall study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Flat Feet', 'description': 'People with flat feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG001', 'title': 'Experimental: High Arches Feet', 'description': 'People with high arches feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}], 'classes': [{'title': 'Hip asymmetry', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Knee asymmetry', 'categories': [{'measurements': [{'value': '0.27', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Ankle asymmetry', 'categories': [{'measurements': [{'value': '0.79', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between directly after 6 months of intervention and baseline values', 'description': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the overall study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Flat Feet', 'description': 'People with flat feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG001', 'title': 'Experimental: High Arches Feet', 'description': 'People with high arches feet according to foot posture index 6 (validated by clinical assessment)'}, {'id': 'OG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}], 'classes': [{'title': 'Hip asymmetry', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Knee asymmetry', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Ankle asymmetry', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change between directly after 12 months of intervention and baseline values', 'description': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the overall study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flat Feet', 'description': 'People with flat feet according to foot posture index (validated by clinical assessment)\n\nFoot 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.'}, {'id': 'FG001', 'title': 'High Arches Feet', 'description': 'People with high arches feet according to foot posture index (validated by clinical assessment)\n\nFoot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.'}, {'id': 'FG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Flat Feet', 'description': 'People with flat feet according to foot posture index (validated by clinical assessment)\n\nFoot 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.'}, {'id': 'BG001', 'title': 'High Arches Feet', 'description': 'People with high arches feet according to foot posture index (validated by clinical assessment)\n\nFoot orthosis for flat feet: Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.'}, {'id': 'BG002', 'title': 'Normal Arches Feet (Control Group)', 'description': 'Control group. This group only completed the baseline visit, therefore no data is reported for the change from baseline outcome measures.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Body's postural symmetry index", 'classes': [{'categories': [{'measurements': [{'value': '0.348', 'spread': '0.037', 'groupId': 'BG000'}, {'value': '0.411', 'spread': '0.046', 'groupId': 'BG001'}, {'value': '0.358', 'spread': '0.039', 'groupId': 'BG002'}, {'value': '0.361', 'spread': '0.039', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Asymetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthothics', 'classes': [{'title': 'Hip asymmetry', 'categories': [{'measurements': [{'value': '1.84', 'spread': '0.94', 'groupId': 'BG000'}, {'value': '1.90', 'spread': '1.16', 'groupId': 'BG001'}, {'value': '1.95', 'spread': '0.98', 'groupId': 'BG002'}, {'value': '1.89', 'spread': '0.98', 'groupId': 'BG003'}]}]}, {'title': 'Knee asymmetry', 'categories': [{'measurements': [{'value': '2.97', 'spread': '1.27', 'groupId': 'BG000'}, {'value': '3.14', 'spread': '1.76', 'groupId': 'BG001'}, {'value': '3.09', 'spread': '1.62', 'groupId': 'BG002'}, {'value': '3.04', 'spread': '1.47', 'groupId': 'BG003'}]}]}, {'title': 'Ankle asymmetry', 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.43', 'groupId': 'BG000'}, {'value': '4.41', 'spread': '3.06', 'groupId': 'BG001'}, {'value': '3.77', 'spread': '3.11', 'groupId': 'BG002'}, {'value': '3.34', 'spread': '2.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2025-06-26', 'size': 422323, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-26T10:09', 'hasProtocol': True}, {'date': '2025-06-26', 'size': 383817, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-26T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2021-12-15', 'resultsFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2021-12-15', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-29', 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months", 'timeFrame': 'Baseline and 2 months', 'description': "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."}, {'measure': "Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months", 'timeFrame': 'Baseline and 6 months', 'description': "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."}, {'measure': "Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months", 'timeFrame': 'Baseline and 12 months', 'description': "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."}, {'measure': 'Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months', 'timeFrame': 'Change between directly after 2 months of intervention and baseline values', 'description': '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.'}, {'measure': 'Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months', 'timeFrame': 'Change between directly after 6 months of intervention and baseline values', 'description': '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.'}, {'measure': 'Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months', 'timeFrame': 'Change between directly after 12 months of intervention and baseline values', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flat Feet', 'High Arched Foot']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\<30\n* No pain\n* No musculoskeletal disorders\n* No balance disorders\n* No pathologies linked to the central nervous system\n* No use of drugs affecting the balance\n\nExclusion Criteria:\n\n* People with foot pathology other than the arch;\n* People with diabetes ;\n* People with severe obesity ;\n* People wearing high heel shoes regularly ;\n* People with degenerative disease ;\n* People with neuromuscular pathology ;\n* People with a circulatory disorder ;\n* People who have had major lower body surgery;\n* Inability to walk 30 minutes continuously.'}, 'identificationModule': {'nctId': 'NCT05163418', 'briefTitle': 'Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System', 'organization': {'class': 'OTHER', 'fullName': 'TOPMED'}, 'officialTitle': 'Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System', 'orgStudyIdInfo': {'id': 'RD-19-0241_CrA_Valg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flat feet', 'description': 'People with flat feet according to foot posture index (validated by clinical assessment)', 'interventionNames': ['Device: Foot orthoses for high arches feet']}, {'type': 'EXPERIMENTAL', 'label': 'High arches feet', 'description': 'People with high arches feet according to foot posture index (validated by clinical assessment)', 'interventionNames': ['Device: Foot orthosis for flat feet']}, {'type': 'NO_INTERVENTION', 'label': 'Normal arches feet (control group)', 'description': 'Control group'}], 'interventions': [{'name': 'Foot orthosis for flat feet', 'type': 'DEVICE', 'description': 'Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.', 'armGroupLabels': ['High arches feet']}, {'name': 'Foot orthoses for high arches feet', 'type': 'DEVICE', 'description': 'Plantar orthotics based on a unique process of footprinting, software design and orthotic printing to create custom 3D printed orthotics.', 'armGroupLabels': ['Flat feet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1S1C1', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'TOPMED', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Edith Martin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TOPMED'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TOPMED', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cryos Technologies Inc.', 'class': 'UNKNOWN'}, {'name': 'Natural Sciences and Engineering Research Council, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}