Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy

Study Overview
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Brief Summary
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Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.

Official Title
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Effect of Botulinum Toxin Type A Associated With Physical Therapy on the Functional Capacity of Children With Spastic Cerebral Palsy: A Randomized Controlled Clinical Trial

Conditions
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Cerebral Palsy, Spastic, Physical Therapy, Botulinum Toxin

Intervention / Treatment
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* Drug: Botulinum toxin type A
* Other: Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of spastic Cerebral Palsy Clinical diagnosis of Dynamic equine feet Exclusion Criteria: Use of phenol in the last 12 months Neurological blocks in the last 6 months Clinical diagnosis of structured orthopedic deformities with surgical indications

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 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
Interventional Model Description: A randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (EG)<br>The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training). | Drug: Botulinum toxin type A<br>* Botulinum Toxin type A The intervention with BoNT-A (Dysport®, Ipsen Biopharmaceutical, USA) was performed in the gastrocnemius and soleus muscles, bilaterally for diplegic children and unilaterally for hemiplegic children.<br>Other: Physical Therapy<br>* Physiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do. The intervention protocol consisted of: Passive stretching of lower limbs, Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors; Strengthening of the antagonist muscles with the application of BoNT-A; Static and dynamic balance training; Up and down stairs; Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.<br>|
| Active Comparator: Control group (CG)<br>GC was treated with physiotherapy (stretching, balancing training, functional walking training). | Other: Physical Therapy<br>* Physiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do. The intervention protocol consisted of: Passive stretching of lower limbs, Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors; Strengthening of the antagonist muscles with the application of BoNT-A; Static and dynamic balance training; Up and down stairs; Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of muscle hypertonia | The classification of hypertonia was performed by Modified Ashworth Scale | 3 months | 
| Functional balance | Functional balance was assessed using the Berg Balance Scale (BBS). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional mobility | Functional mobility was performed by The Timed Up and Go test (TUG test). | 3 months | 
| Functional performance | Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI). | 3 months |