The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces. Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Visual feedback of foot loading during gait.
University of Iowa
Iowa City, Iowa, United States
ACTIVE_NOT_RECRUITINGCornerstone Prosthetics and Orthotics
Everett, Washington, United States
RECRUITINGPeak Plantar Force (Forefoot)
Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.
Time frame: Baseline
Plantar Force Impulse (Forefoot)
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Time frame: Baseline
Peak Plantar Force (Midfoot)
Maximum force (N) collected from the midfoot (middle 30% of sensor) during gait.
Time frame: Baseline
Plantar Force Impulse (Midfoot)
Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Time frame: Baseline
Peak Plantar Force (Hindfoot)
Maximum force (N) collected from the hindfoot (proximal 30% of sensor) during gait.
Time frame: Baseline
Plantar Force Impulse (Hindfoot)
Plantar force impulse (Ns) across the hindfoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Time frame: Baseline
Peak Plantar Force (Total Foot)
Maximum force (N) collected from the total foot (100% of sensor) during gait.
Time frame: Baseline
Plantar Force Impulse (Total Foot)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Plantar force impulse (Ns) across the total foot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Time frame: Baseline