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AFO Adjustments for Musculoskeletal Disorders (AFOHeel Trial)

N/A
Recruiting
Led By Jason M Wilken, PT, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages: 18-70
AFO fits into traditional footwear
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

AFOHeel Trial Summary

This trial will test different heel heights and stiffness's of ankle foot orthosis (AFO) to see how it affects the forces and motion of the lower limb during over-ground walking for people who use AFOs regularly.

Who is the study for?
This trial is for individuals aged 18-70 who use an ankle foot orthosis (AFO) daily due to lower limb issues from injuries or musculoskeletal diseases. They must be able to walk 50 feet without help, have used their current AFO for over two weeks, and fit the AFO into regular shoes.Check my eligibility
What is being tested?
The study tests how different heel heights and stiffness levels in AFOs affect walking. Participants will try out four types of heel cushions with varying properties during controlled walks, comparing these against their usual AFO setup and walking without an AFO if they can.See study design
What are the potential side effects?
While not explicitly mentioned, potential side effects may include discomfort or changes in gait that could lead to muscle strain or falls. The impact on participants' natural walking patterns will be closely monitored.

AFOHeel Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
My ankle-foot orthosis fits in regular shoes.
Select...
I use an ankle-foot orthosis daily due to a leg injury or condition below my knee.
Select...
I can walk 50 feet on my own without help from devices.

AFOHeel Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Center of pressure velocity magnitude
Center of pressure velocity timing
Modified Socket Comfort Score (Comfort)
+3 more
Secondary outcome measures
Ankle Range of Motion
Peak Ankle Moment
Peak Ankle Power
Other outcome measures
Activities-Specific Balance Confidence (ABC)
PROMIS Patient reported outcomes for physical function

AFOHeel Trial Design

24Treatment groups
Experimental Treatment
Group I: Arm 9:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Firm, Short Soft, Tall Soft, Short Firm, NoAFO
Group II: Arm 8:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Firm, Short Soft, NoAFO
Group III: Arm 7:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Firm, Tall Soft, Short Soft, Short Firm, NoAFO
Group IV: Arm 6:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Soft, Short Firm, Short Soft, Tall Firm, NoAFO
Group V: Arm 5:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Soft, Short Firm, Tall Firm, Short Soft, NoAFO
Group VI: Arm 4:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Soft, Short Soft, Short Firm, Tall Firm, NoAFO
Group VII: Arm 3:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Soft, Short Soft, Tall Firm, Short Firm, NoAFO
Group VIII: Arm 2:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Firm, Short Soft, NoAFO
Group IX: Arm 24:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Soft, Tall Firm, NoAFO
Group X: Arm 23:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Firm, Short Soft, Tall Firm, Tall Soft, NoAFO
Group XI: Arm 22:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Firm, Tall Firm, Tall Soft, Short Soft, NoAFO
Group XII: Arm 21:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Firm, Tall Firm, Short Soft, Tall Soft, NoAFO
Group XIII: Arm 20:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Firm, Tall Soft, Short Soft, Tall Firm, NoAFO
Group XIV: Arm 1:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Soft, Tall Firm, Short Soft, Short Firm, NoAFO
Group XV: Arm 19:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Firm, Tall Soft, Tall Firm, Short Soft, NoAFO
Group XVI: Arm 18:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Firm, Tall Soft, NoAFO
Group XVII: Arm 17:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Soft, Short Firm, Tall Soft, Tall Firm, NoAFO
Group XVIII: Arm 16:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Soft, Tall Firm, Tall Soft, Short Firm, NoAFO
Group XIX: Arm 15:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Soft, Tall Firm, Short Firm, Tall Soft, NoAFO
Group XX: Arm 14:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Soft, Tall Soft, Tall Firm, Short Firm, NoAFO
Group XXI: Arm 13:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Short Soft, Tall Soft, Short Firm, Tall Firm, NoAFO
Group XXII: Arm 12:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Firm, Short Firm, Short Soft, Tall Soft, NoAFO
Group XXIII: Arm 11:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Firm, Short Firm, Tall Soft, Short Soft, NoAFO
Group XXIV: Arm 10:Experimental Treatment4 Interventions
Testing Order: Clinical AFO, Tall Firm, Short Soft, Short Firm, Tall Soft, NoAFO

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
447 Previous Clinical Trials
879,682 Total Patients Enrolled
Jason M Wilken, PT, PhDPrincipal InvestigatorUniversity of Iowa
11 Previous Clinical Trials
308 Total Patients Enrolled

Media Library

Short Soft Clinical Trial Eligibility Overview. Trial Name: NCT04800484 — N/A
Musculoskeletal Injuries Research Study Groups: Arm 18:, Arm 23:, Arm 24:, Arm 21:, Arm 7:, Arm 9:, Arm 14:, Arm 15:, Arm 10:, Arm 17:, Arm 20:, Arm 22:, Arm 8:, Arm 11:, Arm 12:, Arm 13:, Arm 16:, Arm 19:, Arm 1:, Arm 2:, Arm 3:, Arm 4:, Arm 5:, Arm 6:
Musculoskeletal Injuries Clinical Trial 2023: Short Soft Highlights & Side Effects. Trial Name: NCT04800484 — N/A
Short Soft 2023 Treatment Timeline for Medical Study. Trial Name: NCT04800484 — 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 ultimate goal of this clinical study?

"The primary metric monitored in this trial is the Centre of Pressure Velocity Magnitude (CPVM). Secondary outcomes include Activities-Specific Balance Confidence (ABC), PROMIS Patient Reported Outcomes for Physical Function, and Numerical Pain Rating Scale. The ABC survey evaluates balance confidence across everyday activities while PROMIS presents physical function through a computerized T-score system. Lastly, pain levels are assessed using an 11 point numerical scale with 0 being no pain and 10 being worst imaginable agony."

Answered by AI

What criteria must one meet in order to be eligible for this experiment?

"Forty patients aged 18 to 70 with peripheral nervous system disorders may be eligible for this trial. To qualify, they must demonstrate the capacity to walk at least 50 feet without an aid and fit into traditional footwear, as well as meet GROUP 1 Inclusion criteria (e.g., having used their current AFO for more than two weeks and being able to move along slowly or moderately)."

Answered by AI

Is it currently possible to register for this clinical experiment?

"Information on clinicaltrials.gov attests that this trial is currently searching for suitable applicants, having been originally posted in November 2019 and revised as recently as January 12th 2022."

Answered by AI

To what extent do individuals aged eighty-five and up qualify for the experiment?

"The age requirement for this clinical trial is 18 to 70 years of age. There are an additional 39 studies offering their services to individuals below the established threshold and 314 investigations available for those beyond 65."

Answered by AI

How many candidates are being included in this trial?

"Affirmative. Clinicaltrials.gov records refer to this clinical trial being actively recruiting, with the first post date of November 7th 2019 and last edit on January 12th 2022. The study requires 40 patients at a single site for participation."

Answered by AI
~11 spots leftby Dec 2025