Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261131
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2005-11-30
Brief Title:
Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
Efficacy and Functional Outcomes of Botulinum Toxin A Injections to Hamstrings in Flexed Knee Gait in Cerebral Palsy A Double-Blind Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-02
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 study proposes to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic changes not observed with normal saline injections in children with spastic diplegic cerebral palsy who walk with a flexed-knee gait pattern
Detailed Description:
This study proposes to 1 to determine if injections of BTX-A to the hamstring muscles result in measurable physiologic body structure and body function changes not observed with normal saline injections in children with spastic diplegic CP who walk with a flexed-knee gait pattern 2 to assess whether physiologic changes translate into functional activity and participation improvements 3 to evaluate familys perception of change in function activity participation and quality of life
This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy CP and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning Disability and Health ICF It is a multi-center prospective randomized double-blind trial comparing results of injection of BTX- A and placebo saline in controls into overactive hamstring muscles using multiple outcomes measures Temporal-spatial gait parameters instrumented 3DGA kinematics passive ROM spasticity measurement with both Ashworth and Tardieu scales muscle strengthcontrol Gross Motor Function Measurement GMFM Pediatric Outcomes Data Collection Instrument PODCI Gillette Functional Assessment Questionnaire FAQ 6-Minute Walk Test and Goal Attainment Scale GAS assessing all ICF domains will be collected at baseline and at 1 month 3 months and 6 months post-injection Power analysis demonstrates the need to randomize 250 children 125 with BTX-A 125 with saline allowing for attrition Nine participating hospitals will contribute patients
This study will demonstrate if BTX-A injected into overactive hamstring muscles of children with spastic cerebral palsy CP and a flexed-knee walking pattern has measurable effects across the spectrum of dimensions of disablement of the International Classification of Functioning Disability and Health ICF It is a multi-center prospective randomized double-blind trial comparing results of injection of BTX- A and placebo saline in controls into overactive hamstring muscles using multiple outcomes measures Temporal-spatial gait parameters instrumented 3DGA kinematics passive ROM spasticity measurement with both Ashworth and Tardieu scales muscle strengthcontrol Gross Motor Function Measurement GMFM Pediatric Outcomes Data Collection Instrument PODCI Gillette Functional Assessment Questionnaire FAQ 6-Minute Walk Test and Goal Attainment Scale GAS assessing all ICF domains will be collected at baseline and at 1 month 3 months and 6 months post-injection Power analysis demonstrates the need to randomize 250 children 125 with BTX-A 125 with saline allowing for attrition Nine participating hospitals will contribute patients
Study Oversight
Has Oversight DMC:
None
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?:
None