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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Procedure: Upper Extremity Tendon transfer
* Procedure: Botulinum Toxin injections in Upper Extremity
* Procedure: Regularly ongoing therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Therapy Group<br>Therapy only | Procedure: Regularly ongoing therapy<br> <br> |
| Active Comparator: Surgery Group<br>surgical intervention | Procedure: Upper Extremity Tendon transfer<br> <br> |
| Active Comparator: Botox Injections<br>botulinum toxin | Procedure: Botulinum Toxin injections in Upper Extremity<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shriners Hospitals Upper Extremity Evaluation (SHUEE) |  | Initial, 6 mon, 1 year | 
| Box & Blocks |  | Initial, 6 mon, 1 year | 
| Assisting Hand Assessment (AHA) |  | Initial, 6 mon, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on questionnaires that assess participation and patient satisfaction at initial, 6 month and 1 year post intervention. |  | Initial, 6 mon, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Tendon Transfer, Botulinum Toxin Type A, Occupational Therapy, Child