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Foot Orthosis

Imaging System Validation for Flatfoot and High-arched Feet

N/A
Waitlist Available
Led By Edith Martin, PhD
Research Sponsored by TOPMED
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No pathologies linked to the central nervous system
No musculoskeletal disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

Study Summary

This trial is testing a new imaging system to see if it's effective in detecting changes in posture for people with flat or high arch feet. If successful, the system could help assess the efficiency of plantar orthotics.

Who is the study for?
This trial is for individuals with a body mass index (BMI) under 30 who have either flat feet or high-arched feet, without musculoskeletal disorders, central nervous system pathologies, balance-affecting drugs use, pain, or balance disorders. It's not for those with circulatory issues, degenerative diseases, neuromuscular conditions, major lower body surgery history, diabetes, severe obesity or other foot pathologies.Check my eligibility
What is being tested?
The study aims to validate the Cryovizion imaging system's ability to accurately detect posture changes and assess how well plantar orthotics improve postural symmetry in people with abnormal arches. Participants will receive custom foot orthoses designed for either flatfoot or high-arched conditions.See study design
What are the potential side effects?
While the trial primarily involves non-invasive imaging and wearing of orthotics which typically have minimal risks; potential side effects may include discomfort from the new orthoses fitment and skin irritation where the device contacts the foot.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any brain or spinal cord diseases.
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I do not have any bone or muscle disorders.
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I am not taking any medication that affects my balance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in body's postural symmetry index at 12 months
Change from baseline in body's postural symmetry index at 2 months
Change from baseline in body's postural symmetry index at 6 months
Secondary outcome measures
Change from baseline in flexion-extension angles of lower body joints during gait at 12 months
Change from baseline in flexion-extension angles of lower body joints during gait at 2 months
Change from baseline in flexion-extension angles of lower body joints during gait at 6 months

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: High arches feetExperimental Treatment1 Intervention
People with high arches feet according to foot posture index (validated by clinical assessment)
Group II: Flat feetExperimental Treatment1 Intervention
People with flat feet according to foot posture index (validated by clinical assessment)
Group III: Normal arches feet (control group)Active Control1 Intervention
Control group

Find a Location

Who is running the clinical trial?

Natural Sciences and Engineering Research Council, CanadaOTHER
57 Previous Clinical Trials
3,031 Total Patients Enrolled
TOPMEDLead Sponsor
7 Previous Clinical Trials
470 Total Patients Enrolled
Cryos Technologies Inc.UNKNOWN

Media Library

Foot orthoses for high arches feet (Foot Orthosis) Clinical Trial Eligibility Overview. Trial Name: NCT05163418 — N/A
Flatfoot Research Study Groups: Flat feet, High arches feet, Normal arches feet (control group)
Flatfoot Clinical Trial 2023: Foot orthoses for high arches feet Highlights & Side Effects. Trial Name: NCT05163418 — N/A
Foot orthoses for high arches feet (Foot Orthosis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05163418 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intake capacity for this trial?

"Affirmative. According to the information on clinicaltrials.gov, this experiment is currently looking for participants after being first published on October 8th 2021 and last modified on December 15th 2021. 80 volunteers are needed at a single medical centre."

Answered by AI

Might I be eligible to participate in this clinical experiment?

"Candidates between eighteenth birthday and fiftieth year are eligible for this experimental protocol, provided that they suffer from foot pain. At the moment, approximately 80 individuals need to be recruited."

Answered by AI

Is there capacity for additional participants in this clinical research?

"Affirmative. Clinicaltrials.gov hosts information that confirms this medical trial is actively seeking participants since its release on October 8th, 2021 and most recent update on December 15th, 2021. Currently 80 individuals are required for the 1 clinical centre involved in the study."

Answered by AI

Does the protocol for this research include patients who are over 35 years of age?

"This medical experiment is seeking participants that are between the age of majority and fifty years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
2021. "Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05163418.
~2 spots leftby Jun 2024
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