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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
No Placebo-Only Group

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.
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.
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.

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 70 years old.
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My ankle-foot orthosis fits in regular shoes.
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I use an ankle-foot orthosis daily due to a leg injury or condition below my knee.
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I can walk 50 feet on my own without help from devices.

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
Center of pressure velocity magnitude
Center of pressure velocity timing
Modified Socket Comfort Score (Comfort)
+3 more
Secondary study objectives
Ankle Range of Motion
Peak Ankle Moment
Peak Ankle Power
Other study objectives
Activities-Specific Balance Confidence (ABC)
PROMIS Patient reported outcomes for physical function

Awards & Highlights

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

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
468 Previous Clinical Trials
893,451 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
~7 spots leftby Dec 2025
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