Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060957
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2003-05-16
Brief Title:
Botulinum Toxin BOTOX for Cerebral Palsy
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Botulinum Toxin for Spasticity in Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2011-05
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:
This study examines botulinum toxin BOTOX or BTX for the treatment of muscle twitches and spasticity associated with cerebral palsy in children Botulinum toxin is a naturally occurring bacterial toxin botulinum toxin that inactivates certain parts of muscles
Detailed Description:
This trial will test the effectiveness of BTX injections versus placebo to reduce plantar-flexor spasticity and improve function and mobility in children with spastic diplegia a common form of cerebral palsy The study will evaluate the effects of the treatment across five domains that relate to disability pathophysiology impairment functional limitation disability and societal limitation
Forty children ages 4 to 12 years will be recruited and randomized into one of two groups Group A will receive BTX Group B will receive a placebo injection Participants will be assessed at the beginning of the trial and at Weeks 3 8 12 and 24 Assessments include quantitative electromyographic kinesiology measurements electromechanical measurement of joint torque across the ankle joint using the Spasticity Measurement System Gross Motor Function Measure physical exam parameters energy expenditure using the Energy Cost Index kinematic gait analysis and the Canadian Occupational Performance Measure
Participants are followed for a total of 6 months Participants initially randomized to Group B will have the opportunity for BTX treatment after 24 weeks
Forty children ages 4 to 12 years will be recruited and randomized into one of two groups Group A will receive BTX Group B will receive a placebo injection Participants will be assessed at the beginning of the trial and at Weeks 3 8 12 and 24 Assessments include quantitative electromyographic kinesiology measurements electromechanical measurement of joint torque across the ankle joint using the Spasticity Measurement System Gross Motor Function Measure physical exam parameters energy expenditure using the Energy Cost Index kinematic gait analysis and the Canadian Occupational Performance Measure
Participants are followed for a total of 6 months Participants initially randomized to Group B will have the opportunity for BTX treatment after 24 weeks
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