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

Primary Purpose

Cerebral Palsy, Spastic, Physical Therapy, Botulinum Toxin

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Botulinum toxin type A
Physical Therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group (EG)

    Control group (CG)

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Severity of muscle hypertonia
    The classification of hypertonia was performed by Modified Ashworth Scale
    Functional balance
    Functional balance was assessed using the Berg Balance Scale (BBS).

    Secondary Outcome Measures

    Functional mobility
    Functional mobility was performed by The Timed Up and Go test (TUG test).
    Functional performance
    Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI).

    Full Information

    First Posted
    July 4, 2018
    Last Updated
    October 9, 2018
    Sponsor
    University of Nove de Julho
    Collaborators
    Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03704155
    Brief Title
    Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    May 2018 (Actual)
    Study Completion Date
    June 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho
    Collaborators
    Claudia Santos Oliveira, Daniela Aparecida Biasotto-Gonzalez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy, Spastic, Physical Therapy, Botulinum Toxin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized controlled clinical trial
    Masking
    ParticipantOutcomes 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.
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group (EG)
    Arm Type
    Experimental
    Arm Description
    The EG was treated with Botulinum toxin type A and physiotherapy (stretching, balancing training, functional walking training).
    Arm Title
    Control group (CG)
    Arm Type
    Active Comparator
    Arm Description
    GC was treated with physiotherapy (stretching, balancing training, functional walking training).
    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum toxin type A
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Physical Therapy
    Intervention Description
    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 Measure Information:
    Title
    Severity of muscle hypertonia
    Description
    The classification of hypertonia was performed by Modified Ashworth Scale
    Time Frame
    3 months
    Title
    Functional balance
    Description
    Functional balance was assessed using the Berg Balance Scale (BBS).
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Functional mobility
    Description
    Functional mobility was performed by The Timed Up and Go test (TUG test).
    Time Frame
    3 months
    Title
    Functional performance
    Description
    Functional performance was assessed using Pediatric Evaluation of Disability Inventory (PEDI).
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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