Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tall Soft
  • Tall Firm
  • Short Soft
  • Short Firm

Treatment groups

40 Participants
are divided into 24 treatment groups

24

Treatment groups

See each treatment group below.

Locations

1
University of Iowa52242, Iowa CityIowa, United States

Sponsors and collaborators

University of Iowa

Lead sponsor

Source ClinicalTrials.gov