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| Name | Class |
|---|---|
| Claudia Santos Oliveira | UNKNOWN |
| Daniela Aparecida Biasotto-Gonzalez | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (EG) | Experimental | The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training). |
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| Control group (CG) | Active Comparator | GC was treated with physiotherapy (stretching, balancing training, functional walking training). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of muscle hypertonia | The classification of hypertonia was performed by Modified Ashworth Scale | 3 months |
| Functional balance | Functional balance was assessed using the Berg Balance Scale (BBS). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional mobility | Functional mobility was performed by The Timed Up and Go test (TUG test). | 3 months |
| Functional performance | Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI). |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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A randomized controlled clinical trial
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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.
| Physical Therapy | Other | 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:
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| 3 months |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |