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
Overview
- Phase
- Not Applicable
- Intervention
- Botulinum toxin type A
- Conditions
- Cerebral Palsy, Spastic
- Sponsor
- University of Nove de Julho
- Enrollment
- 24
- Primary Endpoint
- Severity of muscle hypertonia
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Fabiano Politti
Principal Investigator
University of Nove de Julho
Eligibility Criteria
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
Arms & Interventions
Experimental group (EG)
The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).
Intervention: Botulinum toxin type A
Experimental group (EG)
The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).
Intervention: Physical Therapy
Control group (CG)
GC was treated with physiotherapy (stretching, balancing training, functional walking training).
Intervention: Physical Therapy
Outcomes
Primary Outcomes
Severity of muscle hypertonia
Time Frame: 3 months
The classification of hypertonia was performed by Modified Ashworth Scale
Functional balance
Time Frame: 3 months
Functional balance was assessed using the Berg Balance Scale (BBS).
Secondary Outcomes
- Functional mobility(3 months)
- Functional performance(3 months)