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Ankle Foot Orthosis

Ankle Foot Orthoses for Foot Injuries (AFOCE Trial)

Q: Is this research project currently seeking participants?

<p>According to clinicaltrials.gov, the recruitment of applicants for this trial is ongoing: it was initially announced on February 27th 2020 and most recently modified on January 12th 2022.</p>

Q: For which individuals has enrollment in this experiment been approved?

<p>This study requires 71 individuals, aged between 18 and 65, with a diagnosis of turf toe to participate. These participants must display signs of ankle plantarflexor weakness (under 4/5 on MMT), limited <a href="https://www.withpower.com/clinical-trials/pain">pain</a>-free ankle motion (DF &#x3C; 10° or PF &#x3C; 20°) as well as mechanical pain upon loading onto the hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale). Further criteria include prior lower leg injury sustained over two years ago, ability to walk 50 feet without using a cane or crutch at slow to moderate pace, knowledge of English language and written informed consent.</p>

N/A

Waitlist Available

Led By Jason M. Wilken, PT, PhD

Research Sponsored by Jason Wilken

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages: 18-65

Limited pain free ankle motion (DF<10deg or PF<20deg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

AFOCE Trial Summary

This trial will compare two types of custom-fit carbon fiber braces to see which is more effective in aiding patients with lower leg injuries.

Who is the study for?

This trial is for adults aged 18-65 who have had a severe lower leg injury below the knee over two years ago, can walk at least 50 feet without support, and are experiencing mechanical pain. They must not be pregnant, require a knee stabilizing device for daily activities, or have conditions that would interfere with testing like severe brain injuries or heart conditions.Check my eligibility

What is being tested?

The study compares two custom-fit carbon fiber braces: Reaktiv AFO and PhatBrace AFO. It aims to determine which brace better improves function after serious lower leg injuries by assessing their form, fit, and function in participants' outcomes.See study design

What are the potential side effects?

While specific side effects aren't listed for wearing these orthoses (braces), potential issues could include skin irritation from the brace material, discomfort during use, or an adjustment period to walking with the new device.

AFOCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have limited movement in my ankle without pain.

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I am considered for amputation due to severe ankle/foot problems.

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I have weakness in my ankle when trying to point my toes down.

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I can walk 50 feet without needing a cane or crutch.

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I experience significant pain in my foot when putting weight on it.

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I have had or am a candidate for ankle or hindfoot fusion surgery.

AFOCE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

10 meter shuttle run (10M Shuttle - Timed)

Activities-Specific Balance Confidence (ABC)

Ankle joint power

+11 more

Secondary outcome measures

Ankle joint moment

PROMIS Patient reported outcomes for satisfaction with participation in social activities

Paffenbarger Physical Activity Questionnaire

Other outcome measures

PROMIS Patient reported outcomes for depression

PROMIS Patient reported outcomes for pain behavior

PROMIS Patient reported outcomes for satisfaction with participation in social roles

+3 more

AFOCE Trial Design

2Treatment groups

Experimental Treatment

Group I: BAExperimental Treatment2 Interventions

Participants in this arm will receive the PhatBrace AFO by Bio-Mechanical Composites Inc. first, then the Reaktiv AFO made by FabTech Systems LLC second.

Group II: ABExperimental Treatment2 Interventions

Participants in this arm will receive the Reaktiv AFO made by FabTech Systems LLC first, then the PhatBrace AFO by Bio-Mechanical Composites Inc. second.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Reaktiv AFO

2020

N/A

~60

PhatBrace AFO

2020

N/A

~60

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jason WilkenLead Sponsor

1 Previous Clinical Trials

35 Total Patients Enrolled

Minneapolis Veterans Affairs Medical CenterFED

72 Previous Clinical Trials

14,866 Total Patients Enrolled

Walter Reed National Military Medical CenterFED

137 Previous Clinical Trials

34,443 Total Patients Enrolled

Media Library

PhatBrace AFO (Ankle Foot Orthosis) Clinical Trial Eligibility Overview. Trial Name: NCT03901053 — N/A

Foot Injuries and Disorders Research Study Groups: AB, BA

Foot Injuries and Disorders Clinical Trial 2023: PhatBrace AFO Highlights & Side Effects. Trial Name: NCT03901053 — N/A

PhatBrace AFO (Ankle Foot Orthosis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03901053 — N/A

Frequently Asked Questions

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

Is this research project currently seeking participants?

"According to clinicaltrials.gov, the recruitment of applicants for this trial is ongoing: it was initially announced on February 27th 2020 and most recently modified on January 12th 2022."

Answered by AI

For which individuals has enrollment in this experiment been approved?

"This study requires 71 individuals, aged between 18 and 65, with a diagnosis of turf toe to participate. These participants must display signs of ankle plantarflexor weakness (under 4/5 on MMT), limited pain-free ankle motion (DF < 10° or PF < 20°) as well as mechanical pain upon loading onto the hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale). Further criteria include prior lower leg injury sustained over two years ago, ability to walk 50 feet without using a cane or crutch at slow to moderate pace, knowledge of English language and written informed consent."

Answered by AI

Are participants of this trial required to meet a certain age criterion?

"This medical research is accepting patients aged 18 to 65 as potential participants."

Answered by AI

How many participants are in this research project?

"To commence this clinical trial, 71 willing patients that meet the criteria must enrol. Participants can join at Walter Reed National Military Medical Center in Bethesda, Maryland and University of Iowa in Iowa City, Iowa amongst other medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ankle Foot Orthosis Comparative Effect

Jason Wilken 2020. "Ankle Foot Orthosis Comparative Effect". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03901053.