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

Shriners Hospitals for Children

Status

Terminated

Conditions

Cerebral Palsy

Treatments

Procedure: Botulinum Toxin injections in Upper Extremity

Procedure: Upper Extremity Tendon transfer

Procedure: Regularly ongoing therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00250081

83004-278826

Details and patient eligibility

About

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.

Full description

The specific aims of this study and the methodology for achieving them are:

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.
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.

Enrollment

38 patients

Sex

All

Ages

4 to 17 years old

Volunteers

No Healthy Volunteers

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