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

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ClinicalTrials.gov Identifier: NCT03704155
Recruitment Status : Completed
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Claudia Santos Oliveira
Daniela Aparecida Biasotto-Gonzalez
Information provided by (Responsible Party):
Fabiano Politti, 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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy, Spastic Physical Therapy Botulinum Toxin Drug: Botulinum toxin type A Other: Physical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Fabiano Politti, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03704155     History of Changes
Other Study ID Numbers: BTA
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents