Effects of AFO heel height and stiffness on walking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how different heel heights and stiffness of ankle foot orthoses (AFO) affect the forces and motion of the lower limb during walking in individuals who use AFOs daily. Participants will walk with their AFOs and with heel cushions of varying heights and stiffness, while their movements will be analyzed using motion capture technology and force plates. The goal is to provide evidence that helps clinicians optimize AFO configurations for improved walking function.

Why it matters

Who can join: the full rules

GROUP 1 Patient 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of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.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 it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Jason M Wilken, PT, PhD — University of Iowa
• Study coordinator: Jason M Wilken, PT, PhD
• Email: jason-wilken@uiowa.edu
• Phone: 319-335-6857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.