Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Launched by UNIVERSITY OF IOWA · Nov 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how reliable it is to measure the forces inside a special leg support called a carbon fiber custom dynamic orthosis (CDO). The goal is to use sensors to understand how these forces act on the leg when the CDO is worn. This information can help improve future research, treatment methods, and education about these devices. The study will involve healthy adults aged 18 to 65 who can hop and squat without pain and do not have any recent injuries or medical conditions that could interfere with the testing.

Participants will wear a CDO that fits around the leg below the knee and will be asked to adjust it to different tightness levels: loose, moderate, and tight. During the trial, they will sit, stand, and walk while the sensors measure the forces acting on their leg and foot. Participants will also fill out questionnaires about their experience. It's important to know that individuals with certain health issues, injuries, or who are pregnant are not eligible to take part in this study.

Gender

ALL

Eligibility criteria

• • Group 1 - Able Bodied Participants
• • Inclusion Criteria
• • Between the ages of 18 and 65
• • Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
• • Able to hop without pain
• • Able to perform a full squat without pain
• • Ability to read and write in English and provide written informed consent
• • Ability to fit in a generic sized CDO
• • Exclusion Criteria
• • Diagnosed with a moderate or severe brain injury
• • Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
• • Injuries that would limit performance in this study
• • Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
• • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
• • Require use of an assistive device
• • Unhealed wounds (cuts/abrasions) that would prevent AFO use
• • BMI \> 40
• • Pregnancy
• • Group 2 - AFO Users without Peripheral Neuropathy
• Inclusion Criteria:
• • Between the ages of 18 and 90
• • Use an AFO(s) for daily activities
• • The AFO(s) proximal cuff is compatible with loadpad sensors
• • Have used their AFO(s) for a minimum of 2 weeks
• • Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
• • Ability to read and write in English and provide written informed consent
• • Exclusion Criteria
• • Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
• • Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
• • Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
• • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
• • BMI \> 40
• • Pregnancy
• • Group 3 - AFO Users with Peripheral Neuropathy
• Inclusion Criteria:
• • Between the ages of 18 and 90
• • Use an AFO(s) for daily activities
• • The AFO(s) proximal cuff is compatible with loadpad sensors
• • Have used their AFO(s) for a minimum of 2 weeks
• • Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
• • Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
• • Ability to read and write in English and provide written informed consent
• • Exclusion Criteria
• • Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
• • Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
• • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
• • BMI \> 40
• • Pregnancy