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Completed

NCT Number: NCT03704155

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

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.

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Key information

Conditions

Cerebral Palsy, Spastic Botulinum Toxin Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Physical Therapy

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Severity of muscle hypertonia

    Time frame: 3 months

    The classification of hypertonia was performed by Modified Ashworth Scale

  2. Functional balance

    Time frame: 3 months

    Functional balance was assessed using the Berg Balance Scale (BBS).

Secondary outcomes

  1. Functional mobility

    Time frame: 3 months

    Functional mobility was performed by The Timed Up and Go test (TUG test).

  2. Functional performance

    Time frame: 3 months

    Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI).

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Claudia Santos Oliveira
  • Daniela Aparecida Biasotto-Gonzalez

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2018
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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