Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT01329705
Status:
WITHDRAWN
Last Update Posted:
2013-08-12
First Post:
2011-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic Splinting for Plantarflexion in Spastic Hemiplegia
Sponsor:
Dynasplint Systems, Inc.
Organization:
Study Overview
Official Title:
Dynamic Splinting for Excessive Plantarflexion in Patients With Spastic Hemiplegia: A Randomized, Controlled Study of Gait Analysis
Status:
WITHDRAWN
Status Verified Date:
2013-08
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:
None
Brief Summary:
The purpose of this study is to examine the effectiveness of onabotulinum toxin A (BTX) injections (tone management) and dynamic splinting (contracture reduction) for improving gait patterns in patients with spastic hypertnoia due to stroke or traumatic brain injury and resultant excessive plantarflexion.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: