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

University of Nove de Julho

Status: Completed

Conditions: Cerebral Palsy, Spastic; Botulinum Toxin; Physical Therapy

Treatments: Other: Physical Therapy; Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03704155

BTA

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Experimental group (EG)

Experimental group

Description:

The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).

Treatment:

Other: Physical Therapy

Drug: Botulinum toxin type A

Control group (CG)

Active Comparator group

Description:

GC was treated with physiotherapy (stretching, balancing training, functional walking training).

Treatment:

Other: Physical Therapy