Clinical trial NCT00250081: Comparison of Tendon Transfer, Botox Injections and Ongoing Treatment in Hemiplegic Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Tendon Transfer
Botulinum Toxin Type A
Occupational Therapy
Child
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 38
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shriners Hospitals Upper Extremity Evaluation (SHUEE)
timeFrame: Initial, 6 mon, 1 year
measure: Box & Blocks
timeFrame: Initial, 6 mon, 1 year
measure: Assisting Hand Assessment (AHA)
timeFrame: Initial, 6 mon, 1 year
Secondary outcomes:
measure: Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention.
timeFrame: Initial, 6 mon, 1 year
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Shriners Hospitals for Children Northern California
state: California
city: Wilmington
country: United States
facility: Alfred I duPont Childrens Hospital
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: Shriners Hosptials for Children
state: Florida
city: Chicago
country: United States
facility: Shriners Hospitals for Children Chicago
state: Illinois
city: Shreveport
country: United States
facility: Shriners Hospitals for Children
state: Louisiana
city: Minneapolis
country: United States
facility: Shriners Hospitals for Children, Twin Cities
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Greenville
country: United States
facility: Shriners Hospitals for Children
state: South Carolina
city: Salt Lake City
country: United States
facility: Shriners Hosptials for Children, Intermountain
state: Utah
Study officials:
affiliation: Shriners Hospitals for Children, Northern Calfiornia
name: Michelle James, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospitals for Children, Twin Cities
name: Ann Van Heest, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shriners Hospitals for Children, Northern California
name: Anita Bagley, PhD
role: PRINCIPAL_INVESTIGATOR
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