Carbon Fiber Orthosis for Healthy Subjects

(CuffForce 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.

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.

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.

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.

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.⁶⁷⁸⁹¹⁰