Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2005
End Date:December 2012
Contact:Michelle James, MD
Email:mjames@shrinenet.org
Phone:916-453-2049

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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.

Inclusion Criteria:

- diagnosis of UECP

- aged four to 17 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
We found this trial at
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12502 Usf Pine Drive
Tampa, Florida 33612
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Chicago, Illinois 60707
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Greenville, South Carolina 29605
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Minneapolis, Minnesota 55414
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Shreveport, Louisiana 71103
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Wilmington, Delaware 19803
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