Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250081
Status:
TERMINATED
Last Update Posted:
2014-11-19
First Post:
2005-11-03
Brief Title:
Comparison of Tendon Transfer Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy
Sponsor:
Shriners Hospitals for Children
Organization:
Shriners Hospitals for Children
Study Overview
Official Title:
Multi Center Project Comparison of Functional Outcomes of Tendon Transfer Surgery Botulinum Toxin Injections and Regular Ongoing Treatment in Hemiplegic Upper Extremity Cerebral Palsy
Status:
TERMINATED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual is complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UECP
Brief Summary:
Doctors use different treatments for people with Cerebral Palsy Surgery is one option Botulinum toxin injections are another option these are given directly into spastic muscles to weaken them temporarily Regular ongoing treatment splinting stretching and exercises is another option The investigators want to find out if surgery works better than Botulinum Toxin Botox injections or regular ongoing treatment therapy and if the effects of Botulinum Toxin injections last for longer than six months
Detailed Description:
The specific aims of this study and the methodology for achieving them are
1 To determine if tendon surgery for the forearm wrist and thumb deformities of UECP is more effective than Botulinum toxin injections or regular ongoing treatment at improving function and quality of life for children with UECP Children who are candidates for tendon surgery will be prospectively randomized to one of three treatment groups standard tendon surgery a series of three Botulinum toxin injections over a period of 12 months and regular ongoing treatment Validated tests of cognition function and quality of life with tests of stereognosis and range of motion will be administered before during and after treatment in order to compare outcomes of the three treatment groups
2 To determine if serial Botulinum toxin injections have long-term beneficial effects on upper extremity function which outlast their paralytic effects
Botulinum toxin has been shown to have beneficial effects on UE function while the muscles injected remain weakened by the toxin Clinicians have theorized that improvements in UE function are maintained after the toxin wears off but this has not been proven Children randomized to the Botulinum toxin injection group will receive 3 injections Their function will be tested before the first injection while the paralytic results of the second injection are still in effect and after the paralytic effects of the third injection have worn off and the results compared in order to determine if functional improvements outlast the medicinal effects
1 To determine if tendon surgery for the forearm wrist and thumb deformities of UECP is more effective than Botulinum toxin injections or regular ongoing treatment at improving function and quality of life for children with UECP Children who are candidates for tendon surgery will be prospectively randomized to one of three treatment groups standard tendon surgery a series of three Botulinum toxin injections over a period of 12 months and regular ongoing treatment Validated tests of cognition function and quality of life with tests of stereognosis and range of motion will be administered before during and after treatment in order to compare outcomes of the three treatment groups
2 To determine if serial Botulinum toxin injections have long-term beneficial effects on upper extremity function which outlast their paralytic effects
Botulinum toxin has been shown to have beneficial effects on UE function while the muscles injected remain weakened by the toxin Clinicians have theorized that improvements in UE function are maintained after the toxin wears off but this has not been proven Children randomized to the Botulinum toxin injection group will receive 3 injections Their function will be tested before the first injection while the paralytic results of the second injection are still in effect and after the paralytic effects of the third injection have worn off and the results compared in order to determine if functional improvements outlast the medicinal effects
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