Improvement After Botulinum Toxin Injections to the Arms in Children With Cerebral Palsy

Study Overview
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Brief Summary
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Hypothesis: (1) Treating upper limb hypertonia/spasticity with Botox®, in addition to reducing hypertonia/spasticity, will (a) improve global development, (b) improve function (passive & active), (c) reduce carer burden and (d) improve quality of life. (2) Early treatment with Botox® will have a greater impact on the rate of global development when compared to late treatment.

Detailed Description
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Background: Upper limb function is essential for activities of daily living impacting on quality of life in children with cerebral palsy (CP). In preschool children, dysfunctional upper extremity manipulation not only leads to disability but may further delay global development and substantially increase career burden. Even modest functional improvement could have tremendous long-term benefit in activities of daily living and significantly reduce career burden. Hypertonia is the main symptom causing motor dysfunction in CP. Intramuscular Botulinum toxin injection is one way of treatment. In spite of anecdotal evidence suggesting that early intervention can lead to better outcomes, Israeli physicians are unable to prescribe this treatment for the upper extremities due to limited health insurance coverage. A paucity research evidence is often cited as the reason for limiting the insurance coverage, in particular to the upper limb. We therefore propose to study the effects of Botox® in treating children with CP. Method: Twenty cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4, will be enrolled for the study. Inclusion criteria will be troublesome hypertonia that will respond to treatment with Botox® (as identified by clinical assessment and neurophysiological measures). Since cooperation is crucial for the intensive therapy children with cognitive impairment (IQ<70) or severe behavioural disorders will be excluded. The children will be randomized to one of two groups a Botox group (BG) and a control group (CG). CG children will undergo a program of intensive therapy and BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis , while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg. The intensive therapy will be as clinically required and the therapy program will be fully documented. Outcome measures will include the following: Hypertonia- neurophysiological measures Impairment measures - Grip and Pinch strength, active and passive range of motion at the writs elbow and shoulder Upper extremity function - Quality of Upper Extremity Skills Test (QUEST), Box and Blocks test Function and patient needs assessment - Goal Attainment Scores, Developmental Fine Motor Scale, Pediatric Evaluation and Disability Inventory (PEDI) Quality of life scales (care and comfort hypertonicity questionnaire) All of these measures will be taken once before treatment and then repeated at 7 months, and at 13 months after treatment.

Official Title
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Improvement After Botulinum Toxin A Injections to the Upper Extremities in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: physiotherapy
* Other: Botulinum Toxin A and physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cooperative quadriplegic CP children gross motor function level 4 troublesome hypertonia that will respond to treatment with Botox Exclusion Criteria: cognitive impairment (IQ<70) severe behavioural disorder

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BG<br>cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4 with troublesome hypertonia that will respond to treatment. BG children will be given Botulinum Toxin A, as clinically required, in addition to an equivalent program of intensive therapy | Other: Botulinum Toxin A and physiotherapy<br>* BG children will be given Botox, as clinically required, in addition to an equivalent program of intensive therapy. Botox injection will be tailored according to the specific child. Generally injection site will include biceps and brachioradialis, while flexors of the wrist and digits will be injected according to abnormal postures during function. Maximal total dose will be 23 IU per kg.<br>|
| No Intervention: Control Group<br>control group: Twenty cooperative quadriplegic CP children ages 8-11 years, gross motor function level 4 with troublesome hypertonia that will respond to treatment.CG children will undergo a program of intensive therapy. | Other: physiotherapy<br>* CG children will undergo a program of intensive physiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Hypertonia 2. Impairment measures 3. Upper extremity function 4. Function and patient needs assessment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children with cerebral palsy ages eight to eleven.