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Orthotics

Custom Orthotics for Flatfoot (ODRS Trial)

N/A
Waitlist Available
Led By William R. Ledoux, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediate
Awards & highlights

ODRS Trial Summary

This trial will study the effects of different orthotics on ankle osteoarthritis and adult-onset flat feet. A custom X-ray system will be used to measure foot bone motion. The goal is to find which orthotic design is most effective in improving function.

Who is the study for?
This trial is for adults aged 18-80 with ankle osteoarthritis or adult onset flat feet, who are not candidates for surgery but can walk at least 15 meters. It's not open to those with rheumatoid arthritis, cognitive/language issues preventing consent, no stable contact info, foot ulcers/amputations, or recent severe lower limb problems.Check my eligibility
What is being tested?
The study tests custom orthoses designed to help with ankle osteoarthritis and flat feet. Using a special X-ray system developed by the researchers, they'll see which orthotic designs best improve walking and reduce pain.See study design
What are the potential side effects?
While the study does not involve drugs and thus has fewer side effects risks than medication trials, participants may experience discomfort or skin irritation from wearing the custom orthoses.

ODRS Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
peak hindfoot eversion
peak tibial rotation in degrees

ODRS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: flat footExperimental Treatment1 Intervention
inclusion criteria: 1) diagnosis of flat foot, 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m)
Group II: ankle OAExperimental Treatment1 Intervention
inclusion criteria: 1) diagnosis of ankle OA or PTTD [non-control subjects only], 2) undergoing conservative care (i.e., prescribed a foot orthosis) and deemed not to be a surgical candidate, 3) between 18 and 80 years of age, and 4) ambulatory (able to walk at least 15 m) with the primary impediment to pain-free ambulation being ankle OA or PTTD
Group III: controlActive Control1 Intervention
inclusion criteria: 1) between 18 and 80 years of age, and 2) ambulatory (able to walk at least 15 m)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,394 Total Patients Enrolled
21 Trials studying Osteoarthritis
3,506 Patients Enrolled for Osteoarthritis
University of WashingtonOTHER
1,740 Previous Clinical Trials
1,847,903 Total Patients Enrolled
14 Trials studying Osteoarthritis
10,592 Patients Enrolled for Osteoarthritis
William R. Ledoux, PhDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA

Media Library

Custom Orthoses (Orthotics) Clinical Trial Eligibility Overview. Trial Name: NCT02629731 — N/A
Osteoarthritis Research Study Groups: ankle OA, flat foot, control
Osteoarthritis Clinical Trial 2023: Custom Orthoses Highlights & Side Effects. Trial Name: NCT02629731 — N/A
Custom Orthoses (Orthotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02629731 — N/A

Frequently Asked Questions

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

Are there still openings for participants in this experiment?

"As detailed on clinicaltrials.gov, this particular study is not presently seeking participants as it has been last edited on June 21st 2022. However, there are an abundance of other medical trials that have open recruitments at the moment with a total count of 625 active studies."

Answered by AI

May I be included in this research endeavor?

"For this clinical trial, 35 individuals aged 18 to 80 with flatfoot are being enrolled. To meet the eligibility requirements these patients must be receiving conservative care (i.e., prescribed a foot orthosis) and deemed unfit for surgery; additionally they should have either ankle OA or PTTD, ambulatory capabilities of at least 15m hindered by their condition and lastly within the age range of 18-80 years old."

Answered by AI

Are participants aged 50 or older able to partake in this research?

"The age range for participants of this trial is between 18 and 80. However, the research team has identified 36 studies specifically targeting those under 18, while 585 are available to individuals aged 65 or older."

Answered by AI

Who else is applying?

What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
University of Washington
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Orthotic Dose Response Study
2016. "Orthotic Dose Response Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02629731.
~4 spots leftby Apr 2025
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