Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061139
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-05-21
Brief Title:
Constraint-Based Therapy to Improve Motor Function in Children With 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:
Randomized Controlled Trial of Pediatric CI Therapy
Status:
UNKNOWN
Status Verified Date:
2003-04
Last Known Status:
RECRUITING
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:
Pediatric Constraint-Induced CI Movement therapy is a rehabilitation program designed to improve motor function in children with partial paralysis Children with cerebral palsy may have one arm that has significantly greater function good arm than the other bad arm Restricting the use of the good arm may improve the use of the bad arm In pediatric CI therapy the good arm is put in a sling to force increased use of the bad arm The bad arm is also trained each day for several weeks This study will test the ability of pediatric CI therapy to improve motor function in children with cerebral palsy
Detailed Description:
Cerebral palsy afflicts at least two in 1000 children in the United States and approximately 2000000 children worldwide Behavioral techniques that impact the plasticity of the nervous system need to be incorporated into practical evidence-based therapeutic interventions for this condition
CI therapy was derived from basic research with animal and human subjects Randomized controlled studies indicate that it can substantially reduce the motor deficit of adult patients with mild to moderately severe chronic strokes and can increase their independence over a period of years CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb This gives rise to concentrated repetitive use of the more affected extremity In adults CI therapy has lead to a large increase in use-dependent cortical reorganization involving the recruitment of substantial new regions of the brain in the innervation of more affected extremity movement
The study will evaluate CI therapy in a pediatric population The study will test whether pediatric CI therapy can promote new and improved motor behavior in young children with hemiparesis associated with cerebral palsy Pediatric CI therapy involves total restraint of the unaffected upper extremity with simultaneous repetitive use of the affected extremity for 6 hoursday for 21 consecutive days
Fifty-two children ages 2 to 6 years old with hemiparetic cerebral palsy will be randomly assigned to either the pediatric CI therapy group or to a control group The control group will receive standard rehabilitation therapy All children will have a complete medical evaluation with emphasis on motor function prior to treatment initiation Children will undergo follow-up testing at 1 6 and 12 months post-treatment The primary study assessment tools are the Pediatric Developmental Motor Scales - II PDMS-II DASI - II Bayley Developmental Skills Test Pediatric Motor Activity Log PMAL Child Arm Use Test CAUT and Emerging Behavior Scale EBS
CI therapy was derived from basic research with animal and human subjects Randomized controlled studies indicate that it can substantially reduce the motor deficit of adult patients with mild to moderately severe chronic strokes and can increase their independence over a period of years CI therapy involves motor restriction of the less affected upper extremity for a period of 2 to 3 weeks while concurrently training the more affected upper limb This gives rise to concentrated repetitive use of the more affected extremity In adults CI therapy has lead to a large increase in use-dependent cortical reorganization involving the recruitment of substantial new regions of the brain in the innervation of more affected extremity movement
The study will evaluate CI therapy in a pediatric population The study will test whether pediatric CI therapy can promote new and improved motor behavior in young children with hemiparesis associated with cerebral palsy Pediatric CI therapy involves total restraint of the unaffected upper extremity with simultaneous repetitive use of the affected extremity for 6 hoursday for 21 consecutive days
Fifty-two children ages 2 to 6 years old with hemiparetic cerebral palsy will be randomly assigned to either the pediatric CI therapy group or to a control group The control group will receive standard rehabilitation therapy All children will have a complete medical evaluation with emphasis on motor function prior to treatment initiation Children will undergo follow-up testing at 1 6 and 12 months post-treatment The primary study assessment tools are the Pediatric Developmental Motor Scales - II PDMS-II DASI - II Bayley Developmental Skills Test Pediatric Motor Activity Log PMAL Child Arm Use Test CAUT and Emerging Behavior Scale EBS
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