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

NCT03704155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Claudia Santos Oliveira

    collaborator UNKNOWN

  • Daniela Aparecida Biasotto-Gonzalez

    collaborator UNKNOWN

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-05-31
Completion
2018-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03704155 on ClinicalTrials.gov