Physical Therapy Clinical Trial
Official title:
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
NCT number | NCT03704155 |
Other study ID # | BTA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | June 2018 |
Verified date | October 2018 |
Source | University of Nove de Julho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 12 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Nove de Julho | Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of muscle hypertonia | The classification of hypertonia was performed by Modified Ashworth Scale | 3 months | |
Primary | Functional balance | Functional balance was assessed using the Berg Balance Scale (BBS). | 3 months | |
Secondary | Functional mobility | Functional mobility was performed by The Timed Up and Go test (TUG test). | 3 months | |
Secondary | Functional performance | Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI). | 3 months |
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