NCT06304519

Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke

Identifying the Optimal Patient-Specific Dynamic Ankle-Foot Orthosis Bending Stiffness in an Evidence-Based Manner That Can be Implemented by Clinical Providers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Delaware · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Dynamic ankle-foot orthosis	customized, carbon fiber, passive ankle-foot orthosis

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States