Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352788
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
From Opinion to Evidence Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Sponsor:
Jason Wilken
Organization:
University of Iowa
Study Overview
Official Title:
From Opinion to Evidence Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
Status:
RECRUITING
Status Verified Date:
2024-08
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:
AFOSVA
Brief Summary:
This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses CDOs influences outcomes following traumatic lower extremity injury
Detailed Description:
This study is designed to evaluate how different configurations of two types of carbon fiber custom dynamic orthoses CDOs influence outcomes following traumatic lower extremity injury In this study adult participants who still experiencing deficits including weakness andor immobility more than two years post traumatic lower extremity injury will be randomized and fit with either modular or monolithic CDO
Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order a proposed optimal benchmark configuration a variation with the device in more dorsiflexion and a variation with the device in greater plantarflexion Multiple well-established tests will be used to compare outcomes between the different configurations
Participants will then be evaluated without a CDO and with the CDO in three configurations in a randomized order a proposed optimal benchmark configuration a variation with the device in more dorsiflexion and a variation with the device in greater plantarflexion Multiple well-established tests will be used to compare outcomes between the different configurations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None