NCT04800484 · University of Iowa
The Effects of AFO Heel Height and Stiffness on Gait
(AFOHeel)
What this study is about
The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited.
View original scientific description
The proposed study evaluates the effect of ankle foot orthosis (AFO) heel height and stiffness on the forces and motion of the lower limb during over-ground walking in individuals who use an AFO for daily walking. Previous studies suggest that heel height and stiffness effect limb loading, but these data and the analysis techniques applied are limited. In this study, heel cushions with different height and stiffness's (4 conditions) will be placed in participants shoes and they will walk at controlled and self-selected speeds. Participants will also walk with their AFO as configured prior to enrollment, and with no AFO if possible. The proposed study will provide evidence that can be used by clinicians and researchers to align braces that most effectively improve function during every-day walking.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 GROUP 1 Patient
Exclusion criteria
- 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. GROUP 2 Patient Inclusion Criteria
- 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 GROUP 2 Patient Exclusion Criteria
- 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.
Where
- Iowa City, Iowa
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 31, 2025 · Source of record for eligibility and locations