Carbon Fiber Orthosis for Lower Limb Injury

(AFOCUFF Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jason M Wilken, PT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Iowa

Disqualifiers: Brain injury, Cardiac condition, Arthritis, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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}

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 am between 18 and 50 years old.

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

I can do a full squat without feeling pain.

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.

Trial 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) (Orthosis)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Iowa Iowa City, IA

Who Is Running the Clinical Trial?

University of Iowa Lead Sponsor

Fabtech Systems Collaborator

Bio-Mechanical Composites Collaborator

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] Carbon fiber custom dynamic orthoses (CDOs) have been shown to effectively reduce pain and improve function in military service members with lower-limb impairment, but data are limited for civilians.

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

Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. [2023] Carbon fiber is increasingly being used in ankle-foot orthoses (AFOs). Orthotic devices and carbon fiber-containing devices have been shown to reduce pain and improve function in multiple patient populations. Although the number of publications and interest in carbon fiber AFOs is growing, a systematic evaluation of their effects is lacking.

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

Custom Dynamic Orthoses and Physical Therapist Intervention for Bilateral Midfoot Amputation: A Case Report. [2022] Partial foot amputation is often associated with decreased mobility and function. Recent advances in custom carbon-fiber dynamic ankle-foot orthoses (CDOs) have improved gait, pain, and function following musculoskeletal trauma and can benefit individuals with partial foot amputation. However, limited information is available related to CDO use outside the military. The purpose of this case report is to describe the course of care and outcomes of a civilian provided with CDOs after bilateral transmetatarsal amputation.

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] Ankle-foot orthoses (AFOs) are widely used to restore mobility and reduce pain in individuals with lower extremity pain and disability. The use of a carbon fiber custom dynamic orthosis (CDO) with integrated physical training and psychosocial intervention has been shown to improve outcomes in a military setting, but civilian data are limited.

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

Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. [2022] Patients with calf muscle insufficiency and a calcaneus gait are often dependent on ankle-foot orthoses (AFO). The orthosis is intended to improve walking and posture and should prevent structural deformities. AFOs are often manufactured with a dorsiflexion stop. The design of this type of orthosis has been investigated in several previous studies. In the current study, orthoses with a dorsal carbon fiber spring were compared with the classic design. Five patients with Spina Bifida took part in the current study. All participants underwent a 3D gait analysis including kinematic (VICON infrared cameras) and kinetic (Kistler force plates) data collection. The measurements showed that the carbon spring was able to support the patient during the complete stance phase. It was found that the use of a carbon fiber spring significantly increases the energy return during the 3rd rocker, simulating the natural push-off action (p

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] We surveyed carbon fiber reinforced plastic orthoses (carbon orthoses) and their associated occupational and medical problems based on a questionnaire sent to 310 companies which were members of the Japan Orthotics and Prosthetics Association. Of all the companies, 232 responded: 77 of the 232 companies dealt with ready-made carbon orthoses, 52 dealt with fabricated custom-made orthoses, and 155 did not dealt with carbon orthoses. Although the total number of custom-made carbon ortheses in Japan was 829/ 5 years, there was a difference by region, and one company fabricated only 12 (per 5 years) custom-made carbon orthoses on average. The advantages of the carbon orthosis were the fact that it was "light weight", "well-fitted", had a "good appearance", and "excellent durability", while the disadvantages were that it was "expensive", "high cost of production", of "black color", and required a "longer time for completion", and "higher fabrication techniques". From the standpoint of industrial medicine, "scattering of fine fragments of carbon fibers", "itching on the skin" and "health hazards" were indicated in companies that manufacture the orthosis. In order to make the carbon orthosis more popular, it is necessary to develop a new carbon material that is easier to fabricate at a lower cost, to improve the fabrication technique, and to resolve the occupational and medical problems.