Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304519
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-23
Brief Title:
Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke
Sponsor:
University of Delaware
Organization:
University of Delaware
Study Overview
Official Title:
Identifying the Optimal Patient-Specific Dynamic Ankle-Foot Orthosis Bending Stiffness in an Evidence-Based Manner That Can be Implemented by Clinical Providers
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 individuals 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 patients 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 individuals 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None