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

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

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.

Study Overview

• Status: Completed
• Conditions: Physical Therapy; Cerebral Palsy, Spastic; Botulinum Toxin
• Intervention / Treatment: Drug: Botulinum toxin type A; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group (EG); The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).	Drug: Botulinum toxin type A; 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.; Other: Physical Therapy; 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: Passive stretching of lower limbs,; Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors;; Strengthening of the antagonist muscles with the application of BoNT-A;; Static and dynamic balance training;; Up and down stairs;; Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.
ACTIVE_COMPARATOR: Control group (CG); GC was treated with physiotherapy (stretching, balancing training, functional walking training).	Other: Physical Therapy; 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: Passive stretching of lower limbs,; Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors;; Strengthening of the antagonist muscles with the application of BoNT-A;; Static and dynamic balance training;; Up and down stairs;; Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	3 months

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Daniela Aparecida Biasotto-Gonzalez; Claudia Santos Oliveira

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (ACTUAL): October 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: BTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No