NCT03704155

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy, Spastic
• Physical Therapy
• Botulinum Toxin

Interventions

Type	Name	Description
DRUG	Botulinum 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.
OTHER	Physical 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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-05-01
• Completion: 2018-06-01
• First posted: 2018-10-12
• Last updated: 2018-10-12