The Effects of AFO Heel Height and Stiffness on Gait

Launched by UNIVERSITY OF IOWA · Mar 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how different heel heights and stiffness levels in ankle foot orthoses (AFOs) affect walking. AFOs are devices that help people with certain leg or foot issues walk more easily. The researchers want to find out which combinations of heel height and stiffness work best for improving walking comfort and function in daily life. Participants will walk with their AFOs, as well as with specially designed heel cushions in their shoes, to see how these changes impact their movement.

To be eligible for the study, participants should be between 18 and 70 years old, use an AFO daily for walking, and be able to walk 50 feet without assistance. They should have been using their current AFO for at least two weeks and be able to walk at a slow to moderate pace. Participants can expect to take part in controlled walking sessions, and the study aims to gather helpful information for doctors and researchers to improve AFO designs in the future. Please note that individuals with certain medical conditions or those who experience significant pain while walking may not be able to participate.

Gender

ALL

Eligibility criteria

• • 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.