<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024099</url>
  </required_header>
  <id_info>
    <org_study_id>50019415.3.0000.0030</org_study_id>
    <nct_id>NCT03024099</nct_id>
  </id_info>
  <brief_title>Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Brasilia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hippotherapy is considered a therapeutic modality that provides numerous benefits in the&#xD;
      rehabilitation process and has often been recommended by doctors for children with cerebral&#xD;
      palsy. Despite being in frank ascent, this therapy still lacks scientific evidence.&#xD;
      Objectives: To analyze and compare the effects of hippotherapy program, often 1 or 2 days a&#xD;
      week in gross motor function, trunk balance and functional performance of children with&#xD;
      cerebral palsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study characterized by a controlled experiment with a sample of 24 children, aged between 2&#xD;
      and 4 years, were randomly divided into control group (CG), with 9 participants, with the use&#xD;
      of 1 to week and experimental group, also with 11 participants, 2 times a week intervention.&#xD;
      The call followed protocol and took place once or twice a week lasting 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">January 19, 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effects of weekly frequency of hippotherapy on gross motor function through GMFM (gross motor function measurement) of children with cerebral palsy.</measure>
    <time_frame>one year</time_frame>
    <description>GMFM - quantitative scale assessing 5 dimensions of motor development.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of weekly frequency of hippotherapy on functional performance through the Pediatric Disability Inventory (PEDI) of children with cerebral palsy.</measure>
    <time_frame>one year</time_frame>
    <description>PEDI Inventory - quantitative scale that evaluates the functional performance, among others, for self care, mobility and social function.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Hippotherapy once a week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hippotherapy once a week;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hippotherapy twice a week</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hippotherapy twice a week</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hippotherapy once a week</intervention_name>
    <description>Hippotherapy once a week</description>
    <arm_group_label>Hippotherapy once a week</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hippotherapy twice a week</intervention_name>
    <description>Hippotherapy twice a week</description>
    <arm_group_label>Hippotherapy twice a week</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children from 2 to 6 years of age with diagnosis of Cerebral Palsy, besides medical,&#xD;
             physiotherapeutic and psychological referral with indication of the practice of&#xD;
             Hippotherapy&#xD;
&#xD;
          -  Children classified with GMFCS levels 2, 3, 4 or 5&#xD;
&#xD;
          -  Understanding, agreement and signing of the Free and Informed Consent Form&#xD;
&#xD;
          -  Understanding, agreement and signing of the Free and Informed Assent Term, when&#xD;
             applicable&#xD;
&#xD;
          -  Possibility to participate in a riding program 1 or 2 times a week for a period of 16&#xD;
             weeks&#xD;
&#xD;
          -  Conduct traditional physiotherapy concomitantly 1 or 2 times a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of associated syndromes or structural deformities that make Hippotherapy&#xD;
             impossible&#xD;
&#xD;
          -  Present seizures without medication control&#xD;
&#xD;
          -  Does not have enough hip joint amplitude for riding (about 20 degrees of abduction)&#xD;
&#xD;
          -  To have an invasive or surgical procedure during the study&#xD;
&#xD;
          -  Have previously participated in an Equine Therapy program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Alemdaroglu E, Yanikoglu I, Oken O, Ucan H, Ersoz M, Koseoglu BF, Kapicioglu MI. Horseback riding therapy in addition to conventional rehabilitation program decreases spasticity in children with cerebral palsy: A small sample study. Complement Ther Clin Pract. 2016 May;23:26-9. doi: 10.1016/j.ctcp.2016.02.002. Epub 2016 Feb 13.</citation>
    <PMID>27157954</PMID>
  </reference>
  <reference>
    <citation>Borgi M, Loliva D, Cerino S, Chiarotti F, Venerosi A, Bramini M, Nonnis E, Marcelli M, Vinti C, De Santis C, Bisacco F, Fagerlie M, Frascarelli M, Cirulli F. Effectiveness of a Standardized Equine-Assisted Therapy Program for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Jan;46(1):1-9. doi: 10.1007/s10803-015-2530-6.</citation>
    <PMID>26210515</PMID>
  </reference>
  <reference>
    <citation>Jang B, Song J, Kim J, Kim S, Lee J, Shin HY, Kwon JY, Kim YH, Joung YS. Equine-Assisted Activities and Therapy for Treating Children with Attention-Deficit/Hyperactivity Disorder. J Altern Complement Med. 2015 Sep;21(9):546-53. doi: 10.1089/acm.2015.0067. Epub 2015 Jul 13.</citation>
    <PMID>26167851</PMID>
  </reference>
  <reference>
    <citation>Park J, Lee S, Lee D. The effects of horseback riding simulator exercises on the muscle activity of the lower extremities according to changes in arm posture. J Phys Ther Sci. 2015 Sep;27(9):2731-2. doi: 10.1589/jpts.27.2731. Epub 2015 Sep 30.</citation>
    <PMID>26504280</PMID>
  </reference>
  <reference>
    <citation>Lee DK, Kim EK. The influence of horseback riding training on the physical function and psychological problems of stroke patients. J Phys Ther Sci. 2015 Sep;27(9):2739-41. doi: 10.1589/jpts.27.2739. Epub 2015 Sep 30.</citation>
    <PMID>26504283</PMID>
  </reference>
  <reference>
    <citation>Angsupaisal M, Visser B, Alkema A, Meinsma-van der Tuin M, Maathuis CG, Reinders-Messelink H, Hadders-Algra M. Therapist-Designed Adaptive Riding in Children With Cerebral Palsy: Results of a Feasibility Study. Phys Ther. 2015 Aug;95(8):1151-62. doi: 10.2522/ptj.20140146. Epub 2015 Apr 23.</citation>
    <PMID>25908525</PMID>
  </reference>
  <reference>
    <citation>Kang KY. Effects of mechanical horseback riding on the balance ability of the elderly. J Phys Ther Sci. 2015 Aug;27(8):2499-500. doi: 10.1589/jpts.27.2499. Epub 2015 Aug 21.</citation>
    <PMID>26355558</PMID>
  </reference>
  <reference>
    <citation>Cho SH, Kim JW, Kim SR, Cho BJ. Effects of horseback riding exercise therapy on hormone levels in elderly persons. J Phys Ther Sci. 2015 Jul;27(7):2271-3. doi: 10.1589/jpts.27.2271. Epub 2015 Jul 22.</citation>
    <PMID>26311966</PMID>
  </reference>
  <reference>
    <citation>Kim SR, Cho SH, Kim JW, Lee HC, Brienen M, Cho BJ. Effects of horseback riding exercise therapy on background electroencephalograms of elderly people. J Phys Ther Sci. 2015 Jul;27(7):2373-6. doi: 10.1589/jpts.27.2373. Epub 2015 Jul 22.</citation>
    <PMID>26311985</PMID>
  </reference>
  <reference>
    <citation>Lee N, Park S, Kim J. Effects of hippotherapy on brain function, BDNF level, and physical fitness in children with ADHD. J Exerc Nutrition Biochem. 2015 Jun;19(2):115-21. doi: 10.5717/jenb.2015.15061209. Epub 2015 Jun 30.</citation>
    <PMID>26244130</PMID>
  </reference>
  <reference>
    <citation>Flores FM, Dagnese F, Mota CB, Copetti F. Parameters of the center of pressure displacement on the saddle during hippotherapy on different surfaces. Braz J Phys Ther. 2015 May-Jun;19(3):211-7. doi: 10.1590/bjpt-rbf.2014.0090. Epub 2015 Jun 12.</citation>
    <PMID>26083600</PMID>
  </reference>
  <reference>
    <citation>Earles JL, Vernon LL, Yetz JP. Equine-assisted therapy for anxiety and posttraumatic stress symptoms. J Trauma Stress. 2015 Apr;28(2):149-52. doi: 10.1002/jts.21990. Epub 2015 Mar 17.</citation>
    <PMID>25782709</PMID>
  </reference>
  <reference>
    <citation>Lee CW, Kim SG, An BW. The effects of horseback riding on body mass index and gait in obese women. J Phys Ther Sci. 2015 Apr;27(4):1169-71. doi: 10.1589/jpts.27.1169. Epub 2015 Apr 30.</citation>
    <PMID>25995581</PMID>
  </reference>
  <reference>
    <citation>Kwon JY, Chang HJ, Yi SH, Lee JY, Shin HY, Kim YH. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial. J Altern Complement Med. 2015 Jan;21(1):15-21. doi: 10.1089/acm.2014.0021. Epub 2014 Dec 31.</citation>
    <PMID>25551626</PMID>
  </reference>
  <reference>
    <citation>Temcharoensuk P, Lekskulchai R, Akamanon C, Ritruechai P, Sutcharitpongsa S. Effect of horseback riding versus a dynamic and static horse riding simulator on sitting ability of children with cerebral palsy: a randomized controlled trial. J Phys Ther Sci. 2015 Jan;27(1):273-7. doi: 10.1589/jpts.27.273. Epub 2015 Jan 9.</citation>
    <PMID>25642090</PMID>
  </reference>
  <reference>
    <citation>Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014 Nov;55(6):1736-42. doi: 10.3349/ymj.2014.55.6.1736.</citation>
    <PMID>25323914</PMID>
  </reference>
  <reference>
    <citation>Kwon JY, Chang HJ, Lee JY, Ha Y, Lee PK, Kim YH. Effects of hippotherapy on gait parameters in children with bilateral spastic cerebral palsy. Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031.</citation>
    <PMID>21530725</PMID>
  </reference>
  <reference>
    <citation>McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: 10.1016/j.apmr.2009.01.011.</citation>
    <PMID>19480872</PMID>
  </reference>
  <reference>
    <citation>Tseng SH, Chen HC, Tam KW. Systematic review and meta-analysis of the effect of equine assisted activities and therapies on gross motor outcome in children with cerebral palsy. Disabil Rehabil. 2013 Jan;35(2):89-99. doi: 10.3109/09638288.2012.687033. Epub 2012 May 26.</citation>
    <PMID>22630812</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Brasilia</investigator_affiliation>
    <investigator_full_name>Alessandra Vidal Prieto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>hippotherapy Gross Motor Function Functional performance.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024099
org study id: 50019415.3.0000.0030
nct id: NCT03024099
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Effects of weekly frequency of hippotherapy on gross motor function through GMFM (gross motor function measurement) of children with cerebral palsy.
time frame: one year
description: GMFM - quantitative scale assessing 5 dimensions of motor development.
measure: Effects of weekly frequency of hippotherapy on functional performance through the Pediatric Disability Inventory (PEDI) of children with cerebral palsy.
time frame: one year
description: PEDI Inventory - quantitative scale that evaluates the functional performance, among others, for self care, mobility and social function.
arm group label: Hippotherapy once a week
arm group type: Experimental
description: Hippotherapy once a week;
arm group label: Hippotherapy twice a week
arm group type: Experimental
description: hippotherapy twice a week
intervention type: Other
intervention name: Hippotherapy once a week
description: Hippotherapy once a week
arm group label: Hippotherapy once a week
intervention type: Other
intervention name: Hippotherapy twice a week
description: Hippotherapy twice a week
arm group label: Hippotherapy twice a week
criteria: 
gender: All
minimum age: 2 Years
maximum age: 4 Years
healthy volunteers: No
citation: Alemdaroglu E, Yanikoglu I, Oken O, Ucan H, Ersoz M, Koseoglu BF, Kapicioglu MI. Horseback riding therapy in addition to conventional rehabilitation program decreases spasticity in children with cerebral palsy: A small sample study. Complement Ther Clin Pract. 2016 May;23:26-9. doi: 10.1016/j.ctcp.2016.02.002. Epub 2016 Feb 13.
PMID: 27157954
citation: Borgi M, Loliva D, Cerino S, Chiarotti F, Venerosi A, Bramini M, Nonnis E, Marcelli M, Vinti C, De Santis C, Bisacco F, Fagerlie M, Frascarelli M, Cirulli F. Effectiveness of a Standardized Equine-Assisted Therapy Program for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Jan;46(1):1-9. doi: 10.1007/s10803-015-2530-6.
PMID: 26210515
citation: Jang B, Song J, Kim J, Kim S, Lee J, Shin HY, Kwon JY, Kim YH, Joung YS. Equine-Assisted Activities and Therapy for Treating Children with Attention-Deficit/Hyperactivity Disorder. J Altern Complement Med. 2015 Sep;21(9):546-53. doi: 10.1089/acm.2015.0067. Epub 2015 Jul 13.
PMID: 26167851
citation: Park J, Lee S, Lee D. The effects of horseback riding simulator exercises on the muscle activity of the lower extremities according to changes in arm posture. J Phys Ther Sci. 2015 Sep;27(9):2731-2. doi: 10.1589/jpts.27.2731. Epub 2015 Sep 30.
PMID: 26504280
citation: Lee DK, Kim EK. The influence of horseback riding training on the physical function and psychological problems of stroke patients. J Phys Ther Sci. 2015 Sep;27(9):2739-41. doi: 10.1589/jpts.27.2739. Epub 2015 Sep 30.
PMID: 26504283
citation: Angsupaisal M, Visser B, Alkema A, Meinsma-van der Tuin M, Maathuis CG, Reinders-Messelink H, Hadders-Algra M. Therapist-Designed Adaptive Riding in Children With Cerebral Palsy: Results of a Feasibility Study. Phys Ther. 2015 Aug;95(8):1151-62. doi: 10.2522/ptj.20140146. Epub 2015 Apr 23.
PMID: 25908525
citation: Kang KY. Effects of mechanical horseback riding on the balance ability of the elderly. J Phys Ther Sci. 2015 Aug;27(8):2499-500. doi: 10.1589/jpts.27.2499. Epub 2015 Aug 21.
PMID: 26355558
citation: Cho SH, Kim JW, Kim SR, Cho BJ. Effects of horseback riding exercise therapy on hormone levels in elderly persons. J Phys Ther Sci. 2015 Jul;27(7):2271-3. doi: 10.1589/jpts.27.2271. Epub 2015 Jul 22.
PMID: 26311966
citation: Kim SR, Cho SH, Kim JW, Lee HC, Brienen M, Cho BJ. Effects of horseback riding exercise therapy on background electroencephalograms of elderly people. J Phys Ther Sci. 2015 Jul;27(7):2373-6. doi: 10.1589/jpts.27.2373. Epub 2015 Jul 22.
PMID: 26311985
citation: Lee N, Park S, Kim J. Effects of hippotherapy on brain function, BDNF level, and physical fitness in children with ADHD. J Exerc Nutrition Biochem. 2015 Jun;19(2):115-21. doi: 10.5717/jenb.2015.15061209. Epub 2015 Jun 30.
PMID: 26244130
citation: Flores FM, Dagnese F, Mota CB, Copetti F. Parameters of the center of pressure displacement on the saddle during hippotherapy on different surfaces. Braz J Phys Ther. 2015 May-Jun;19(3):211-7. doi: 10.1590/bjpt-rbf.2014.0090. Epub 2015 Jun 12.
PMID: 26083600
citation: Earles JL, Vernon LL, Yetz JP. Equine-assisted therapy for anxiety and posttraumatic stress symptoms. J Trauma Stress. 2015 Apr;28(2):149-52. doi: 10.1002/jts.21990. Epub 2015 Mar 17.
PMID: 25782709
citation: Lee CW, Kim SG, An BW. The effects of horseback riding on body mass index and gait in obese women. J Phys Ther Sci. 2015 Apr;27(4):1169-71. doi: 10.1589/jpts.27.1169. Epub 2015 Apr 30.
PMID: 25995581
citation: Kwon JY, Chang HJ, Yi SH, Lee JY, Shin HY, Kim YH. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial. J Altern Complement Med. 2015 Jan;21(1):15-21. doi: 10.1089/acm.2014.0021. Epub 2014 Dec 31.
PMID: 25551626
citation: Temcharoensuk P, Lekskulchai R, Akamanon C, Ritruechai P, Sutcharitpongsa S. Effect of horseback riding versus a dynamic and static horse riding simulator on sitting ability of children with cerebral palsy: a randomized controlled trial. J Phys Ther Sci. 2015 Jan;27(1):273-7. doi: 10.1589/jpts.27.273. Epub 2015 Jan 9.
PMID: 25642090
citation: Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014 Nov;55(6):1736-42. doi: 10.3349/ymj.2014.55.6.1736.
PMID: 25323914
citation: Kwon JY, Chang HJ, Lee JY, Ha Y, Lee PK, Kim YH. Effects of hippotherapy on gait parameters in children with bilateral spastic cerebral palsy. Arch Phys Med Rehabil. 2011 May;92(5):774-9. doi: 10.1016/j.apmr.2010.11.031.
PMID: 21530725
citation: McGibbon NH, Benda W, Duncan BR, Silkwood-Sherer D. Immediate and long-term effects of hippotherapy on symmetry of adductor muscle activity and functional ability in children with spastic cerebral palsy. Arch Phys Med Rehabil. 2009 Jun;90(6):966-74. doi: 10.1016/j.apmr.2009.01.011.
PMID: 19480872
citation: Tseng SH, Chen HC, Tam KW. Systematic review and meta-analysis of the effect of equine assisted activities and therapies on gross motor outcome in children with cerebral palsy. Disabil Rehabil. 2013 Jan;35(2):89-99. doi: 10.3109/09638288.2012.687033. Epub 2012 May 26.
PMID: 22630812
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: Alessandra Vidal Prieto
investigator title: Principal Investigator
mesh term: Cerebral Palsy
sharing ipd: No