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

NCT03704155 | Completed DMC

• 1 other identifier: BTA
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy, Spastic; Physical Therapy; Botulinum Toxin

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Functional mobility

  3 months

• Functional performance

  3 months

Study Arms (2)

Experimental group (EG)

EXPERIMENTAL

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

Drug: Botulinum toxin type A; Other: Physical Therapy

Control group (CG)

ACTIVE COMPARATOR

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

Other: Physical Therapy

Interventions

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.

Experimental group (EG)

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: * 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.

Control group (CG); Experimental group (EG)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of spastic Cerebral Palsy
• Clinical diagnosis of Dynamic equine feet

You may not qualify if:

• Use of phenol in the last 12 months
• Neurological blocks in the last 6 months
• Clinical diagnosis of structured orthopedic deformities with surgical indications

Sponsors & Collaborators

• University of Nove de Julho: lead
• Claudia Santos Oliveira: collaborator
• Daniela Aparecida Biasotto-Gonzalez: collaborator

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled clinical trial

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: October 12, 2018
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share