Carbon Fiber Orthosis for Lower Limb Injury

(AFOCUFF Trial)

Overseen By Kirsten M Anderson, BSE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Brain injury, Cardiac condition, Arthritis, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Carbon Fiber Custom Dynamic Orthosis (CDO) for lower limb injury?

Research shows that carbon fiber custom dynamic orthoses (CDOs) can reduce pain and improve function, especially in military service members with lower-limb impairments. Additionally, carbon fiber ankle-foot orthoses (AFOs) have been found to enhance mobility and reduce pain in various patient groups. ^{1 2 3 4 5}

Is the carbon fiber orthosis safe for humans?

Carbon fiber orthoses, like ankle-foot orthoses (AFOs) and custom dynamic orthoses (CDOs), have been used to reduce pain and improve function in various patient groups, including military personnel and civilians. While specific safety data is limited, these devices are generally considered safe and beneficial for improving mobility and reducing pain. ^{1 2 3 4 5}

What makes the Carbon Fiber Custom Dynamic Orthosis (CDO) treatment unique for lower limb injury?

The Carbon Fiber Custom Dynamic Orthosis (CDO) is unique because it is lightweight, well-fitted, and durable, providing improved mobility and reduced pain for individuals with lower limb injuries. Unlike other treatments, it integrates physical training and psychosocial intervention, which has shown to enhance outcomes, particularly in military settings. ^{1 2 3 4 6}

What is the purpose of this trial?

Carbon fiber custom dynamic orthoses (CDOs) consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy during gait, and a carbon fiber foot plate that supports the foot and allows bending of the posterior strut. The proximal cuff is a primary interface between the patient and the CDO and may influence comfort, preference, limb mechanics and loading, and effective stiffness of the CDO. The important role of the proximal cuff has not been examined. The purpose of this study is to determine the effects of CDO proximal cuff design on patient reported outcomes, limb mechanics and loading, and CDO mechanical characteristics.

Research Team

Jason M Wilken, PT, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for adults aged 18-50 with unilateral ankle PTOA who can walk 50 feet and hop without pain, do a full squat, and don't need walking aids. They must not have severe lower extremity issues, inflammatory arthritis, recent surgeries planned on the study limb or be pregnant. A BMI over 40 or serious brain injury also disqualifies.

Inclusion Criteria

I don't have leg, back pain, open wounds, or infections right now.

I can do a full squat without feeling pain.

I have post-traumatic osteoarthritis.

Exclusion Criteria

I have been diagnosed with a moderate or severe brain injury.

I need a device like a brace for my ankle or knee to do everyday tasks.

I have had health issues or injuries that stopped me from working or exercising in the past 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing without an orthosis and with four different proximal cuff designs

4-6 weeks

Multiple visits for testing with different orthosis designs

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

Treatment Details

Interventions

• Carbon Fiber Custom Dynamic Orthosis (CDO)

Trial Overview The study tests how different cuff designs of Carbon Fiber Custom Dynamic Orthoses (CDOs) affect comfort, preference, leg mechanics and loading during walking. CDOs are braces that support the leg below the knee to aid in movement for those with leg injuries.

Participant Groups

Group I: CUFF-D Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-D

Group II: CUFF-C Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-C

Group III: CUFF-B Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-B

Group IV: CUFF-A Experimental Treatment 1 Intervention

The first study CDO will be designated CUFF-A

Group V: NoCDO Active Control 1 Intervention

Participants will be tested with no CDO

Carbon Fiber Custom Dynamic Orthosis (CDO) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Approved in European Union as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Approved in Canada as Carbon Fiber Custom Dynamic Orthosis for:

• Foot drop
• Plantar flexion weakness
• Ankle instability
• Neurological conditions affecting the lower limbs

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Fabtech Systems

Collaborator

Trials

3

Recruited

80+

Bio-Mechanical Composites

Collaborator

Trials

2

Recruited

60+

Findings from Research

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 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]

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]

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]

The study compared traditional ankle-foot orthoses (AFOs) with a new design featuring a dorsal carbon fiber spring in five patients with Spina Bifida, showing that the carbon spring significantly enhances energy return during walking, particularly during the push-off phase (p<0.05).

The use of carbon fiber springs resulted in more natural ankle and knee movements, suggesting improved functionality over classic AFO designs, although careful alignment during fitting is crucial for optimal performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. Wolf, SI., Alimusaj, M., Rettig, O., et al.[2022]

A survey of 232 companies revealed that carbon fiber reinforced plastic orthoses are lightweight, well-fitted, and durable, but they are also expensive and require advanced fabrication techniques.

Health concerns were noted in manufacturing, including skin irritation and potential hazards from carbon fiber fragments, highlighting the need for improved materials and techniques to enhance safety and accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Survey of carbon fiber reinforced plastic orthoses and occupational and medical problems based on a questionnaire administered to companies involved in the manufacture of prosthetics and orthotics]. Kaneshiro, Y., Furuta, N., Makino, K., et al.[2019]

References

1. France 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. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. [2023]

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

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. [2022]

4. France 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

[Survey of carbon fiber reinforced plastic orthoses and occupational and medical problems based on a questionnaire administered to companies involved in the manufacture of prosthetics and orthotics]. [2019]