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Ankle-Foot Orthosis (AFO) Heel Height and Stiffness Study

This study is looking at how different heel heights and stiffnesses in ankle-foot orthoses (AFOs) affect how people walk. Researchers will test four types of heel wedges: Tall Soft, Tall Firm, Short Soft, and Short Firm. You might be able to join if you are between 18 and 70 years old, use an AFO daily because of a leg injury or muscle/nerve disease, and can walk 50 feet without help. The study aims to understand how these different heel wedges impact the forces and movements in your lower leg while walking. Success will be measured by changes in how your foot pushes off the ground (center of pressure velocity) and your comfort with the AFO. The study is currently unclear about its status and plans to enroll 40 participants.

Study design
This is an interventional study planning to enroll 40 participants. It is not specified if it is randomized or blinded.
What's involved
You will walk with your AFO using different heel cushions, and possibly without your AFO. Researchers will use reflective markers on your skin and force plates to measure your walking.
Compensation
Not stated in the trial record.
Follow-up
Follow-up is not specified beyond measurements taken at baseline.

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NCT04800484

The Effects of AFO Heel Height and Stiffness on Gait

Recruiting
NAAges 18–70Interventional
University of Iowa
~40 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:Tall SoftTall FirmShort SoftShort Firm

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Center of pressure velocity timing
Measured over Baseline
+5 more outcomes measured

Conditions

Musculoskeletal Injury
Musculoskeletal Diseases
Peripheral Nervous System Diseases

Explore related trials

Musculoskeletal DisorderMusculoskeletal InjuryPeripheral Nervous System Disorder

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Jason M Wilken, PT, PhD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Jason M Wilken, PT, PhD
[email protected]
319-335-6857
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ages: 18-70
Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and/or nerve injury, ankle arthritis)
Greater than 2 weeks using their current AFO
Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
Ability to walk at a slow to moderate pace
AFO fits into traditional footwear
Able to read and write in English and provide written informed consent
Ages: 18-70
Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes)
Greater than 2 weeks using their current AFO (unilateral or bilateral)
Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.)
AFO fits into traditional footwear
Ability to walk at a slow to moderate pace
Able to read and write in English and provide written informed consent

Exclusion

Pain \> 6/10 while walking during testing or an increase in pain during testing of \> 2/10.
Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity).
Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth).
Limited contralateral lower limb function due to injury or neurological/musculoskeletal disorder.
Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
Use of an AFO that crosses the knee (Knee brace)
Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing
Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.
Body Mass index \> 40.
Pain \> 6/10 while walking or an increase in pain during testing of \> 2/10
Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity)
Limited function due to limb injury (e.g. fracture, muscle and/or nerve injury)
Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot.
Use of an AFO that crosses the knee (Knee brace)
Insufficient space in shoe to accommodate the tallest heel wedge and their AFO
Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study
Body Mass index \> 40.

What this trial measures

  • Center of pressure velocity timingBaseline

    Timing of peak center of pressure velocity (percent stance) during gait.

  • Center of pressure velocity magnitudeBaseline

    Magnitude of peak center of pressure velocity (m/s) during gait.

  • Modified Socket Comfort Score (Comfort)Baseline

    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.

  • Modified Socket Comfort Score (Smoothness)Baseline

    Smoothness scores range from 0 = least smooth to 10 = most smooth.

  • Numerical Pain Rating ScaleBaseline

    Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.

  • Participant wedge preferenceBaseline

    The participant will rank order their preference for their Clinical AFO, Tall Soft, Tall Firm, Short Soft, or Short Firm wedge on a questionnaire.