Custom Orthoses for Lower Extremity Injuries

(LoadsolCP Trial)

Recruiting at 1 trial location

Overseen By Kirsten M Anderson, BSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Severe pain, Spinal injury, Heart condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

60 Participants Needed

Trial Summary

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the use of custom orthoses for lower extremity injuries safe for humans?

The research does not provide specific safety data for custom orthoses, but patient satisfaction surveys indicate some dissatisfaction, suggesting a need for more detailed research to ensure safety and effectiveness. ^{1 2 3 4 5}

How is the treatment of custom orthoses for lower extremity injuries different from other treatments?

Custom orthoses for lower extremity injuries are unique because they are tailored specifically to the individual's anatomy using advanced computer-aided design (CAD) and manufacturing techniques, such as selective laser sintering, which ensures a precise fit and potentially better performance compared to premanufactured options. ^{3 4 6 7 8}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Accommodation

Participants walk without the CDO, then with the CDO following initial prescription

2 weeks

1 visit (in-person)

Training

Participants receive training with or without visual feedback of foot loading forces

4 weeks

2 visits (in-person)

Take-home Use

Participants use the CDO at home to further reduce forces

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Visual Feedback

Trial Overview 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.

Participant Groups

Group I: Provided Visual Feedback Active Control 1 Intervention

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

Group II: No Visual Feedback Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Cornerstone Clinics, Everett, WA

Collaborator

Trials

1

Recruited

60+

Findings from Research

The study developed a novel framework for creating customized passive-dynamic ankle-foot orthoses (PD-AFOs) using computer-aided design and rapid manufacturing techniques, achieving high dimensional accuracy within a 2 mm tolerance.

Subjective evaluations from two nondisabled participants indicated positive experiences with the customized PD-AFOs during gait, suggesting their potential effectiveness and comfort for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dimensional accuracy of ankle-foot orthoses constructed by rapid customization and manufacturing framework. Schrank, ES., Stanhope, SJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development and initial validation of the Orthotic Patient-Reported Outcomes-Mobility (OPRO-M): An item bank for evaluating mobility of people who use lower-limb orthoses. [2023]

2. Scotland pubmed.ncbi.nlm.nih.gov

Standardised classification system for bespoke thermoplastic ankle foot orthoses. [2022]

3. Sweden pubmed.ncbi.nlm.nih.gov

Use and Usability Of Custom-Made Knee-Ankle-Foot Orthoses In Polio Survivors with Knee Instability: A Cross-Sectional Survey. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dimensional accuracy of ankle-foot orthoses constructed by rapid customization and manufacturing framework. [2022]

5. France pubmed.ncbi.nlm.nih.gov

Questionnaire assessment of patient satisfaction with lower limb orthoses from a district hospital. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Combined effects of a valgus knee brace and lateral wedge foot orthotic on the external knee adduction moment in patients with varus gonarthrosis. [2013]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of foot orthoses on children with lower extremity growing pains. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Custom-fit versus premanufactured braces. [2021]