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Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy
This study is currently recruiting participants.
Study NCT00250081   Information provided by Shriners Hospitals for Children
First Received: November 3, 2005   Last Updated: September 5, 2008   History of Changes

November 3, 2005
September 5, 2008
February 2005
December 2008   (final data collection date for primary outcome measure)
Scores on functional assessments at initial, 6 month and 1 year post intervention. [ Time Frame: 1 year ]
Scores on functional assessments at initial, 6 month and 1 year post intervention.
Complete list of historical versions of study NCT00250081 on ClinicalTrials.gov Archive Site
Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.
Same as current
 
Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy
Multi Center Project: Comparison of Functional Outcomes of Tendon Transfer Surgery, Botulinum Toxin Injections and Regular Ongoing Treatment in Hemiplegic Upper Extremity Cerebral Palsy

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.

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.

 
Interventional
Other, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Cerebral Palsy
  • Procedure: Upper Extremity Tendon transfer
  • Procedure: Botulinum Toxin injections in Upper Extremity
  • Procedure: Regulalry ongoing therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of UECP
  • aged five to 15 years
  • candidate for standard surgical management (tendon transfer)

Exclusion Criteria:

  • subject could benefit from procedures in addition to standard surgical management and releases, and these procedures could be performed at the same anesthetic (for example, elbow flexor release)
  • previous Botulinum toxin injection session in the affected UE in < 1 year
  • previous ipsilateral UE surgery
  • primary language other than English or Spanish
  • subject and/or parent unwilling to attend eight therapy sessions and perform home exercise protocol
Both
5 Years to 15 Years
No
Contact: Michelle James, MD 916-453-2049 mjames@shrinenet.org
Contact: Anita Bagley, PhD 916-453-2280 abagley@shrinenet.org
United States,   Canada
 
NCT00250081
Michelle James, MD, Shriners Hospital for Children, Northern California
9196-200513113
Shriners Hospitals for Children
 
Principal Investigator: Michelle James, MD Shriners Hospitals for Children, Northern Calfiornia
Principal Investigator: Ann Van Heest, MD Shriners Hospitals for Children, Twin Cities
Principal Investigator: Anita Bagley, PhD Shriners Hospitals for Children, Northern California
Shriners Hospitals for Children
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP