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Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hippotherapy once a week
Hippotherapy twice a week
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring hippotherapy Gross Motor Function Functional performance.

Eligibility Criteria

2 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children from 2 to 6 years of age with diagnosis of Cerebral Palsy, besides medical, physiotherapeutic and psychological referral with indication of the practice of Hippotherapy
  • Children classified with GMFCS levels 2, 3, 4 or 5
  • Understanding, agreement and signing of the Free and Informed Consent Form
  • Understanding, agreement and signing of the Free and Informed Assent Term, when applicable
  • Possibility to participate in a riding program 1 or 2 times a week for a period of 16 weeks
  • Conduct traditional physiotherapy concomitantly 1 or 2 times a week

Exclusion Criteria:

  • Presence of associated syndromes or structural deformities that make Hippotherapy impossible
  • Present seizures without medication control
  • Does not have enough hip joint amplitude for riding (about 20 degrees of abduction)
  • To have an invasive or surgical procedure during the study
  • Have previously participated in an Equine Therapy program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Hippotherapy once a week

    Hippotherapy twice a week

    Arm Description

    Hippotherapy once a week;

    hippotherapy twice a week

    Outcomes

    Primary Outcome Measures

    Effects of weekly frequency of hippotherapy on gross motor function through GMFM (gross motor function measurement) of children with cerebral palsy.
    GMFM - quantitative scale assessing 5 dimensions of motor development.
    Effects of weekly frequency of hippotherapy on functional performance through the Pediatric Disability Inventory (PEDI) of children with cerebral palsy.
    PEDI Inventory - quantitative scale that evaluates the functional performance, among others, for self care, mobility and social function.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2017
    Last Updated
    April 16, 2019
    Sponsor
    University of Brasilia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03024099
    Brief Title
    Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    January 19, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Brasilia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The hippotherapy is considered a therapeutic modality that provides numerous benefits in the rehabilitation process and has often been recommended by doctors for children with cerebral palsy. Despite being in frank ascent, this therapy still lacks scientific evidence. Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a week in gross motor function, trunk balance and functional performance of children with cerebral palsy.
    Detailed Description
    Study characterized by a controlled experiment with a sample of 24 children, aged between 2 and 4 years, were randomly divided into control group (CG), with 9 participants, with the use of 1 to week and experimental group, also with 11 participants, 2 times a week intervention. The call followed protocol and took place once or twice a week lasting 30 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    hippotherapy Gross Motor Function Functional performance.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hippotherapy once a week
    Arm Type
    Experimental
    Arm Description
    Hippotherapy once a week;
    Arm Title
    Hippotherapy twice a week
    Arm Type
    Experimental
    Arm Description
    hippotherapy twice a week
    Intervention Type
    Other
    Intervention Name(s)
    Hippotherapy once a week
    Intervention Description
    Hippotherapy once a week
    Intervention Type
    Other
    Intervention Name(s)
    Hippotherapy twice a week
    Intervention Description
    Hippotherapy twice a week
    Primary Outcome Measure Information:
    Title
    Effects of weekly frequency of hippotherapy on gross motor function through GMFM (gross motor function measurement) of children with cerebral palsy.
    Description
    GMFM - quantitative scale assessing 5 dimensions of motor development.
    Time Frame
    one year
    Title
    Effects of weekly frequency of hippotherapy on functional performance through the Pediatric Disability Inventory (PEDI) of children with cerebral palsy.
    Description
    PEDI Inventory - quantitative scale that evaluates the functional performance, among others, for self care, mobility and social function.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children from 2 to 6 years of age with diagnosis of Cerebral Palsy, besides medical, physiotherapeutic and psychological referral with indication of the practice of Hippotherapy Children classified with GMFCS levels 2, 3, 4 or 5 Understanding, agreement and signing of the Free and Informed Consent Form Understanding, agreement and signing of the Free and Informed Assent Term, when applicable Possibility to participate in a riding program 1 or 2 times a week for a period of 16 weeks Conduct traditional physiotherapy concomitantly 1 or 2 times a week Exclusion Criteria: Presence of associated syndromes or structural deformities that make Hippotherapy impossible Present seizures without medication control Does not have enough hip joint amplitude for riding (about 20 degrees of abduction) To have an invasive or surgical procedure during the study Have previously participated in an Equine Therapy program

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy

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