Custom Orthoses for Lower Extremity Injuries
(Loadsol CP Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Iowa

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-65 with lower extremity injuries who need a custom dynamic orthosis and can walk without crutches. Participants must have specific ankle or foot conditions, wear certain shoe sizes, and be able to follow instructions in English. Exclusions include severe pain, CNS pathologies, other braces involved, serious medical conditions that affect testing ability, high BMI (>40), sensory impairments affecting walking or instruction compliance, and pregnancy.

Inclusion Criteria

I can walk at a slow to moderate pace.

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

+4 more

Exclusion Criteria

Pregnancy

I experience severe pain, over 9 out of 10, when walking.

I have a condition that limits the use of my opposite limb.

+5 more

Participant Groups

The study tests how well a carbon fiber custom dynamic orthosis (CDO) reduces foot loading during initial use, after training with/without visual feedback of foot pressure, and following home usage. It aims to see if the CDO offloads pressure effectively and whether additional feedback or use improves outcomes.

2Treatment groups

Active Control

Group I: Provided Visual FeedbackActive Control1 Intervention

Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.

Group II: No Visual FeedbackActive Control1 Intervention

Participants will receive typical accommodation training after being prescribed the CDO.