Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432055
Status:
COMPLETED
Last Update Posted:
2009-02-24
First Post:
2007-02-05
Brief Title:
Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
Sponsor:
Sunnaas Rehabilitation Hospital
Organization:
Sunnaas Rehabilitation Hospital
Study Overview
Official Title:
A Randomized Controlled Trial on Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
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 purpose of this project is to investigate if there is a significant difference in active joint range of motion questionnaire on gait function and health related quality of life between patients randomized to treatment with Botulinum toxin type A and patients randomized to placebo treatment
Detailed Description:
Cerebral palsy CP is a constellation of symptoms and conditions defined as lifelong motor dysfunction resulting rom a non-progressive brain lesion occurring pre- peri- or postnatal before the second year of life CP consists of different aspect of motor disorder including spasticity paresis incoordination and dystonia
There is scarce knowledge about the association between spasticity pain and physical function in the adult CP-population and the systematic follow up of patients with CP typically ends at the age of eighteen Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A Btx-A in leg and thigh muscles and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation
Botulinum toxin A Btx- A is a highly effective treatment in the management of spasticity The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al Subsequently randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP There is an implicit and as of yet unproven assumption that there is no indication for this treatment in the adult CP-population
There is scarce knowledge about the association between spasticity pain and physical function in the adult CP-population and the systematic follow up of patients with CP typically ends at the age of eighteen Frequently used intervention in spastic cerebral palsy for children with gait problems are injections with Botulinum toxin type A Btx-A in leg and thigh muscles and three dimensional-gait analysis has become a standard procedure in treatment decision and evaluation
Botulinum toxin A Btx- A is a highly effective treatment in the management of spasticity The first reported success of use of Btx-A in children with cerebral palsy was made in 1993 by Koman et al Subsequently randomized controlled studies on children with spastic type of cerebral palsy has documented that Btx-A is effective and safe in the management of muscle spasticity in children with CP There is an implicit and as of yet unproven assumption that there is no indication for this treatment in the adult CP-population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCTnumber 2006-001427-19 | None | None | None |