Botulinum Toxin, Cerebral Palsy, Spastic, Physical Therapy
Conditions
Brief summary
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.
Interventions
DRUGBotulinum toxin type A
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.
OTHERPhysical Therapy
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.
Sponsors
Claudia Santos Oliveira
Daniela Aparecida Biasotto-Gonzalez
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Evaluator 1: triage, random draw of treatments to be performed; Evaluator 2: BoNT-A application; Evaluator 3: assessment data collection; Evaluator 4: physical therapy treatment. Evaluator 3 was blinded in relation to the groups.
Intervention model description
A randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of muscle hypertonia | 3 months | The classification of hypertonia was performed by Modified Ashworth Scale |
| Functional balance | 3 months | Functional balance was assessed using the Berg Balance Scale (BBS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional mobility | 3 months | Functional mobility was performed by The Timed Up and Go test (TUG test). |
| Functional performance | 3 months | Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI). |
Outcome results
None listed