drugset / Trial / NCT03704155
Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy
Completed
24 enrolled
University of Nove de Julho
Claudia Santos Oliveira · collabDaniela Aparecida Biasotto-Gonzalez · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2017-01
- Primary completion
- 2018-05
- Completion
- 2018-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | — | — |