Effect of Custom Dynamic Orthoses on Forefoot Loading (LoadsolCP)

University of Iowa

Status

Not yet enrolling

Conditions

Lower Extremity Injuries

Treatments

Other: Visual Feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT06710119

202207100

Details and patient eligibility

About

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.

Full description

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).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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