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Orthosis

Custom Dynamic Orthoses for Foot Injuries (AFOSVA Trial)

N/A
Recruiting
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
Ability to be fit with an orthosis
Weakness of ankle plantarflexors (<4/5 on manual muscle test)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how different types of carbon fiber leg braces affect the recovery of people with leg injuries.

Who is the study for?
This trial is for adults aged 18-65 who are at least two years post a traumatic injury below the knee, have weak ankle muscles, can be fitted with an orthosis, and experience pain or limited motion in their ankle. It's not suitable for those outside this age range or with conditions that would prevent them from using the orthosis.
What is being tested?
The study compares two types of carbon fiber custom dynamic orthoses (CDOs) - modular and mono designs - to see which one better improves outcomes after lower extremity injuries.
What are the potential side effects?
While specific side effects aren't listed, potential issues could include discomfort, skin irritation, or increased pain due to the fit and function of the different CDO configurations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can be fitted for a brace.
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I have weakness in my ankle when trying to push down.
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I experience significant pain in my foot when putting weight on it.
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I am a candidate for or have had ankle or hindfoot fusion surgery.
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I am considered for amputation due to a severe ankle/foot injury.
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I am between 18 and 65 years old.
Select...
I have very limited movement in my ankle.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ankle Zero Moment Crossing (%stance)
Center of Pressure Velocity Magnitude (m/s)
Center of Pressure Velocity Timing (%stance)
+13 more
Secondary study objectives
PROMIS Depression
PROMIS Satisfaction with Participation in Discretionary Social Activities
PROMIS Satisfaction with Participation in Social Activities
Other study objectives
Ankle Range of Motion (degrees)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: NoCDO, C, B, AExperimental Treatment2 Interventions
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A.
Group II: NoCDO, C, A, BExperimental Treatment2 Interventions
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B.
Group III: NoCDO, B, C, AExperimental Treatment2 Interventions
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A.
Group IV: NoCDO, B, A, CExperimental Treatment2 Interventions
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C.
Group V: NoCDO, A, C, BExperimental Treatment2 Interventions
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B.
Group VI: NoCDO, A, B, CExperimental Treatment2 Interventions
Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.

Find a Location

Who is running the clinical trial?

Jason WilkenLead Sponsor
1 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Foot Injuries
54 Patients Enrolled for Foot Injuries
Mayo ClinicOTHER
3,333 Previous Clinical Trials
3,060,140 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
901 Previous Clinical Trials
939,591 Total Patients Enrolled
~23 spots leftby Aug 2027
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