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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a custom-made foot brace aids individuals with lower leg injuries by reducing foot stress. Researchers are testing whether visual feedback, such as showing the weight placed on the foot, enhances the brace's effectiveness. Participants will either receive this visual feedback or not, to determine which approach is more effective. Ideal candidates for this trial have a lower leg injury that limits daily activities, can walk 25 feet without crutches, and require a custom foot brace. As an unphased trial, this study allows participants to contribute to innovative research that could improve recovery for others with similar injuries.

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.

What prior data suggests that this custom dynamic orthosis is safe for lower extremity injuries?

Research has shown that using visual feedback during training is safe and helpful. For example, a study on runners with lower-leg injuries found that real-time visual feedback reduced their risk of injury. This indicates the method is well-received and might help prevent problems. Another study examined older adults using visual feedback devices to improve balance and leg strength. The results were positive, showing that participants managed the visual feedback well without major issues.

In summary, research supports that visual feedback is generally safe for participants and can help reduce injury risks and improve physical function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using visual feedback in custom orthoses because it offers a new way to enhance rehabilitation for lower extremity injuries. Unlike standard treatments that rely solely on accommodation training, this approach integrates visual cues to help patients better understand and adjust their movements. This method could potentially speed up recovery by providing real-time information that helps patients correct their gait or posture more effectively. By offering immediate feedback, this technique aims to improve the overall effectiveness of orthotic interventions, making rehabilitation more efficient and personalized.

What evidence suggests that this trial's treatments could be effective for lower extremity injuries?

Studies have shown that custom-made carbon fiber braces can aid individuals with lower body injuries. Research indicates that these braces reduce pain, support the injured area, and redirect pressure away from it. They relieve pain more effectively than standard heel lifts. In this trial, some participants will receive visual feedback along with the custom braces, enhancing effectiveness by helping users see and adjust their weight distribution on their feet. Overall, these findings suggest that custom braces, particularly when combined with visual feedback, could be a promising option for managing lower limb injuries. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12400727/

The current state of 3D-printed orthoses clinical outcomes 3D-printed orthoses can enhance gait parameters, functional performance, comfort, fit, and effectiveness, compared to conventional methods.

2. cda-amc.ca cda-amc.ca/sites/default/files/pdf/htis/2022/RC1410%20Custom%20Foot%20Orthotics%20Final.pdf

Custom-Made Foot Orthotics for People With Lower Limb ... One RCT9 reported that pain relief was statistically significantly higher with custom-made foot orthoses compared to prefabricated heel lifts in children with ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0966636223013796

The clinical and biomechanical effects of customized foot ... This study aimed to determine the effects of heat moulded CFOs on foot and lower limb kinematics when compared with prefabricated foot orthoses (PFOs) and ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595390/

Custom-Made Foot Orthotics for People With Lower Limb ... One RCT reported that pain relief was statistically significantly higher with custom-made foot orthoses compared to prefabricated heel lifts in children with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05456295

Comparative Effect of Carbon Fiber Orthosis Cuff Design ... Carbon fiber custom dynamic orthoses (CDOs) can improve outcomes by reducing pain, supporting the limb, and transferring forces around the limb through the CDO.

6. mdpi.com mdpi.com/2673-1592/3/4/35

A Visual Feedback Tool for Quantitative Pressure ... A visual feedback tool for quantitative pressure monitoring in lower-limb prosthetic sockets. Prosthesis, 3(4), 394-405.

7. d-scholarship.pitt.edu d-scholarship.pitt.edu/38792/1/4_24_ETD_Krista%20L%20Kutina%20Final.pdf

Development and Efficacy of a Mobile Real Time Visual ... However notably, a recent study of runners with lower extremity injury demonstrated training with real time visual feedback reduced the risk ...

8. researchgate.net researchgate.net/publication/332175169_Effects_of_Training_with_a_Custom-Made_Visual_Feedback_Device_on_Balance_and_Functional_Lower-Extremity_Strength_in_Older_Adults_A_Randomized_Controlled_Trial

Effects of Training with a Custom-Made Visual Feedback ... This study aimed to investigate the effects of visual feedback training using the custom-made visual feedback device on balance and functional lower-extremity ...