Effect of Custom Dynamic Orthoses on Forefoot Loading

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).

Patient Inclusion criteria

• Ages: 18-65
• Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
• Shoe size between women's 8 and 13.5 or men's 6.5 and 13
• Any of the following: weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
• Ability to walk 25 feet without using a cane or crutch
• Ability to walk at a slow to moderate pace
• Able to read and write in English and provide written informed consent

Patient Exclusion criteria

• Pain > 9/10 while walking
• Ankle weakness as a result of spinal cord injury or central nervous system pathology
• AFO or CDO prescription that includes a knee brace or goes up to thigh
• Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
• Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
• BMI greater than 40
• Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
• Pregnancy