Status:
RECRUITING
The Effects of AFO Heel Height and Stiffness on Gait
Lead Sponsor:
University of Iowa
Conditions:
Musculoskeletal Injury
Musculoskeletal Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 d...
Detailed Description
In this study the investigators to evaluate 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 u...
Eligibility Criteria
Inclusion
- 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of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study.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.
Exclusion
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04800484
Start Date
November 7 2019
End Date
January 1 2027
Last Update
December 31 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242