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Cerebral PalsyNCT03024099

Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy

A study testing Hippotherapy once a week and Hippotherapy twice a week in people with Cerebral Palsy, run by University of Brasilia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 4 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Hippotherapy once a week and Hippotherapy twice a week
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Feb 2016to 19 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the 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.

Conditions
Cerebral Palsy
Being tested
Hippotherapy once a week, Hippotherapy twice a week
Keywords
hippotherapy Gross Motor Function Functional performance.
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hippotherapy once a weekOther

    Hippotherapy once a week

  • Hippotherapy twice a weekOther

    Hippotherapy twice a week

Study groups in NCT03024099
Study groupRoleWhat they receive
Hippotherapy once a weekExperimentalHippotherapy once a week;
Receives: Other: Hippotherapy once a week
Hippotherapy twice a weekExperimentalhippotherapy twice a week
Receives: Other: Hippotherapy twice a week

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: one year

  2. 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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2017 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2016
  4. Study completion19 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03024099
Sponsor's protocol ID
50019415.3.0000.0030
Status last verified
Jan 2017
First submitted
8 Jan 2017
Last updated
17 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 27157954
  • 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.

    PubMed 26210515
  • 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.

    PubMed 26167851
  • 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.

    PubMed 26504280
  • 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.

    PubMed 26504283
  • 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.

    PubMed 25908525
  • 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.

    PubMed 26355558
  • 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.

    PubMed 26311966
  • 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.

    PubMed 26311985
  • 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.

    PubMed 26244130
  • 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.

    PubMed 26083600
  • 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.

    PubMed 25782709
  • 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.

    PubMed 25995581
  • 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.

    PubMed 25551626
  • 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.

    PubMed 25642090

Questions about this trial

What is this clinical trial studying?

A study testing Hippotherapy once a week and Hippotherapy twice a week in people with Cerebral Palsy, run by University of Brasilia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03024099, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.

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