Carbon Fiber Orthosis for Healthy Subjects

(CuffForce Trial)

Overseen By Kirsten M Anderson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Brain injury, Heart disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how forces operate inside carbon fiber orthoses (special braces) using sensors. The study could improve future designs and instructions for using these braces. It involves three groups: healthy adults, people using ankle-foot orthoses (AFOs) without nerve damage, and those using AFOs with nerve damage. Suitable candidates include healthy adults who can hop and squat without pain, AFO users who can walk 50 feet unaided, and those with or without peripheral neuropathy (nerve damage affecting feeling in the limbs). As an unphased study, this trial offers participants the chance to contribute to innovative research that could enhance brace design and usage.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on physical testing with orthoses, so it's unlikely that medication use is a concern, but please confirm with the study coordinators.

What prior data suggests that this carbon fiber orthosis is safe for use in healthy subjects?

Research shows that carbon fiber braces, like the ones being tested, are generally easy to use. These braces support and stabilize the ankle and foot. Made from carbon fiber, they are both strong and lightweight. This material stores and returns energy during movement, making walking or standing easier.

Studies indicate that people, including those in the military, have used these braces safely to aid recovery and improve movement. No significant evidence of serious harm has been found from using these braces. Most users report better performance and comfort when wearing them.

For those considering joining a trial with similar braces, evidence suggests they are safe and can be very helpful for those needing extra support in their lower legs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the carbon fiber orthosis because it explores how different proximities and tightness levels of the orthosis cuff might optimize support and comfort for users. Unlike traditional orthoses, which often have a one-size-fits-all approach, this study is investigating personalized adjustments to the orthosis, potentially offering more effective mobility assistance. By understanding these variations, the trial could lead to more tailored and efficient orthotic solutions, enhancing user experience and effectiveness.

What evidence suggests that this orthosis is effective for assessing forces within CDOs?

Research has shown that custom-made carbon fiber braces, known as carbon fiber custom dynamic orthoses (CDOs), can significantly improve mobility and reduce pain. One study found that 92% of patients reported better movement, and many experienced less pain. Other studies have found that these braces can help people walk faster and move more easily. The benefits stem from the CDO's design, which uses a carbon fiber piece to store and release energy, facilitating movement. In this trial, participants will be assigned to different groups to test the effects of wearing a CDO with varying proximal cuff tightness or without a CDO. Overall, CDOs have proven effective in enhancing mobility and comfort. ^{6 7 8 9 10}

Who Is on the Research Team?

Jason Wilken, PT,PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 with no lower extremity or spine pain, open wounds, infections, or disorders affecting work/exercise in the past 6 months. Participants must be able to hop and squat without pain and provide informed consent in English.

Inclusion Criteria

I can do a full squat without feeling pain.

Ability to read and write in English and provide written informed consent

I am healthy with no recent pain, wounds, infections, or conditions that limit my activity.

Exclusion Criteria

I do not have visual or hearing impairments that affect my walking or understanding instructions.

I had surgery or couldn't use my leg properly for more than 6 weeks due to an injury.

My BMI is over 35.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants complete baseline testing including comfort and pain assessments, and force measurements while sitting, standing, and walking with and without CDOs.

1 week

1 visit (in-person)

Experimental Testing

Participants complete study activities with CDOs fastened at different tightness levels (Loose, Moderate, Tight) and self-selected tightness, with force measurements taken.

1-2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for any delayed effects or feedback on comfort and usability of the CDOs.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carbon Fiber Orthosis Proximal Cuff

Trial Overview

The study tests if sensors can reliably measure forces inside Carbon Fiber Custom Dynamic Orthoses (CDOs) on the leg. It involves using generic CDOs at different tightness levels while sitting, standing, walking, and completing questionnaires.

How Is the Trial Designed?

Group I: Tight Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO fastened to a tight proximal cuff tightness

Group II: SSCT Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO fastened to their self-selected proximal cuff tightness

Group III: Moderate Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO fastened to a moderate proximal cuff tightness

Group IV: Loose Experimental Treatment 1 Intervention

Participants will complete study activities while wearing a CDO fastened to a loose proximal cuff tightness

Group V: NoCDO Active Control 1 Intervention

Participants will complete study activities without wearing a CDO

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Published Research Related to This Trial

A study of 283 adult neuromuscular patients using anterior shell carbon fiber ankle-foot orthoses (CFAFOs) showed that 89% of patients were satisfied or extremely satisfied with the device, indicating high acceptance and effectiveness.

The findings suggest that anterior shell CFAFOs are a suitable option for most neuromuscular patients experiencing distal leg weakness, providing a positive alternative to other orthotic styles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One clinic's experience with carbon fiber orthoses in neuromuscular disease. Mnatsakanian, A., Kissel, JT., Terry, P., et al.[2018]

In a study of 131 adult patients using a carbon fiber custom dynamic orthosis (CDO) combined with training, 92% reported improved physical function and 69% reported reduced maximum pain, indicating high initial effectiveness of the intervention.

The improvement in pain and physical function was significantly influenced by baseline pain levels and patient characteristics such as sex, suggesting that personalized approaches may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effect of a carbon fiber custom dynamic orthosis and integrated rehabilitation on self-reported physical function, pain, speed, and agility in civilians. Williamson, JN., Grunst, MM., Lynn, J., et al.[2023]

A study of 131 adults using carbon fiber custom dynamic orthoses (CDOs) showed that most participants experienced significant long-term improvements in pain and physical function, with follow-up occurring an average of 4 years after intervention.

Long-term outcomes were strongly predicted by initial pain levels and short-term functional improvements, indicating that early progress with CDOs and training can lead to sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of long-term pain and function in individuals who received a custom dynamic orthosis and device-centric care pathway. Williamson, JN., Grunst, MM., Lynn, J., et al.[2023]

A 72-year-old man fitted with custom carbon-fiber dynamic ankle-foot orthoses (CDOs) after bilateral transmetatarsal amputation experienced significant improvements in gait biomechanics, including over 40% increases in ankle push-off power and plantarflexor moments after just one week of use.

With additional training from a physical therapist, the patient reported enhanced mobility, confidence, and quality of life, demonstrating that CDOs can effectively support recovery and function in individuals with partial foot amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. Anderson, KM., Evans, RE., Connerly, CE., et al.[2022]

The custom carbon fiber passive dynamic ankle foot orthosis (PDAFO) significantly reduced forefoot maximal force by 66% and contact pressures by 49% in patients with arthritic foot and ankle conditions, indicating its efficacy in off-loading pressure during walking.

Participants using the PDAFO experienced greater loading on the brace compared to their unbraced foot, suggesting that the device effectively redistributes weight and provides measurable pressure relief for those with mobility difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive Dynamic Ankle Foot Orthoses Use in Civilian Patients with Arthritic Conditions of the Foot and Ankle. Feng, J., Weiss, J., Thompson, A., et al.[2023]

The Intrepid Dynamic Exoskeletal Orthosis (IDEO) significantly improved functional performance in patients with lower extremity trauma compared to other orthotic options and no brace, particularly in agility, power, and speed tests.

After using the IDEO and participating in high-intensity rehabilitation, most patients who initially considered amputation opted for limb salvage instead, indicating the potential of this intervention to positively impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of orthosis design on functional performance. Patzkowski, JC., Blanck, RV., Owens, JG., et al.[2016]

A systematic review of 78 articles found that carbon fiber ankle-foot orthoses (AFOs) are effective in improving outcomes like walking speed, pain reduction, and balance in various patient populations, including those with lower-limb trauma and neurological disorders.

The review identified five commonly used carbon fiber AFO devices, each tailored to specific conditions, highlighting the importance of device design and patient population in achieving favorable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. Grunst, MM., Wiederien, RC., Wilken, JM.[2023]

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Carbon Fiber Orthosis for Healthy Subjects (CuffForce Trial)

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The Intrepid Dynamic Exoskeletal Orthosis (IDEO®) is a custom carbon fiber ankle-foot orthosis (AFO) that has helped wounded Service Members return to a ...