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

Not Applicable

Completed

• Conditions: Cerebral Palsy, Spastic; Physical Therapy; Botulinum Toxin
• Interventions: Drug: Botulinum toxin type A; Other: Physical Therapy

• Registration Number: NCT03704155
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2018-05
• Study Completion: 2018-06
• Study First Submitted: 2018-07-04
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-09
• Last Update Submitted: 2018-10-09
• Study First Posted: 2018-10-12
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (EG)	Physical Therapy	The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).
Control group (CG)	Physical Therapy	GC was treated with physiotherapy (stretching, balancing training, functional walking training).
Experimental group (EG)	Botulinum toxin type A	The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).

Primary Outcome Measures

Name	Time	Method
Severity of muscle hypertonia	3 months	The classification of hypertonia was performed by Modified Ashworth Scale
Functional balance	3 months	Functional balance was assessed using the Berg Balance Scale (BBS).

Secondary Outcome Measures

Name	Time	Method
Functional mobility	3 months	Functional mobility was performed by The Timed Up and Go test (TUG test).
Functional performance	3 months	Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI).