Carbon Fiber Orthosis for Healthy Subjects

(CuffForce Trial)

Overseen By Kirsten M Anderson, BSE

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

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 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 data supports the effectiveness of the treatment Carbon Fiber Orthosis Proximal Cuff, Carbon Fiber Custom Dynamic Orthoses (CDOs), Ankle Foot Orthoses (AFOs), Intrepid Dynamic Exoskeletal Orthosis (IDEO)?

Research shows that carbon fiber orthoses, including ankle-foot orthoses (AFOs) and custom dynamic orthoses (CDOs), can reduce pain and improve function in people with lower-limb impairments, particularly in military settings. Although data for civilians is limited, these devices have been beneficial in improving mobility and reducing pain in various patient populations. ^{1 2 3 4 5}

Is the carbon fiber orthosis safe for humans?

The available research suggests that carbon fiber orthoses, including various designs like the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and custom dynamic orthoses (CDOs), have been used safely in both military and civilian populations to reduce pain and improve function, although specific safety evaluations are limited. ^{1 2 3 6 7}

How is the carbon fiber orthosis treatment different from other treatments?

The carbon fiber orthosis is unique because it uses lightweight carbon fiber material to create a custom dynamic support for the ankle and foot, which can improve mobility and reduce pain. Unlike other treatments, it combines physical training and psychosocial support, and has shown promising results in military settings, although civilian data is still limited. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education. Study participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. . Group 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness. For all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.

Research Team

Jason Wilken, PT,PhD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

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

Passive Dynamic Ankle Foot Orthoses Use in Civilian Patients with Arthritic Conditions of the Foot and Ankle. [2023]

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

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

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

One clinic's experience with carbon fiber orthoses in neuromuscular disease. [2018]

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

Comparative effect of orthosis design on functional performance. [2016]