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

Stopped early · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT00250081

Run by

Shriners Hospitals for Children

People needed

38

Starts

2005-02-01

Expected to finish

2013-05-01

Last updated by the study team

2014-11-19

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• diagnosis of UECP
• aged four to 17 years
• candidate for standard surgical management (tendon transfer)

You may not qualify if…

• 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

Where it is running

• Shriners Hospitals for Children Northern California — Sacramento, California, United States
• Alfred I duPont Childrens Hospital — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Shriners Hosptials for Children — Tampa, Florida, United States
• Shriners Hospitals for Children Chicago — Chicago, Illinois, United States
• Shriners Hospitals for Children — Shreveport, Louisiana, United States
• Shriners Hospitals for Children, Twin Cities — Minneapolis, Minnesota, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Shriners Hospitals for Children — Greenville, South Carolina, United States
• Shriners Hosptials for Children, Intermountain — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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