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.
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 group | Role | What they receive |
|---|---|---|
| Hippotherapy once a week | Experimental | Hippotherapy once a week; Receives: Other: Hippotherapy once a week |
| Hippotherapy twice a week | Experimental | hippotherapy 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.
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
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.
- First posted18 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Vidal Prieto, University of Brasilia
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 27157954Borgi 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 26210515Jang 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 26167851Park 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 26504280Lee 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 26504283Angsupaisal 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 25908525Kang 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 26355558Cho 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 26311966Kim 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 26311985Lee 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 26244130Flores 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 26083600Earles 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 25782709Lee 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 25995581Kwon 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 25551626Temcharoensuk 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weekly Hippotherapy Frequency on Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03024099
- Acronym / sponsor ID
- 50019415.3.0000.0030
- Conditions
- Cerebral Palsy
- Keywords
- hippotherapy Gross Motor Function Functional performance.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hippotherapy once a week | Experimental | Other: Hippotherapy once a weekHippotherapy once a week; |
| Hippotherapy twice a week | Experimental | Other: Hippotherapy twice a weekhippotherapy twice a week |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hippotherapy once a weekHippotherapy once a week | Other | Hippotherapy once a week |
| Hippotherapy twice a weekHippotherapy twice a week | Other | Hippotherapy twice a week |
Primary outcome
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
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.
Time frame: one year
PEDI Inventory - quantitative scale that evaluates the functional performance, among others, for self care, mobility and social function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 27157954Alemdaroglu 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.
- Background: PubMed 26210515Borgi 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.
- Background: PubMed 26167851Jang 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.
- Background: PubMed 26504280Park 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.
- Background: PubMed 26504283Lee 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.
- Background: PubMed 25908525Angsupaisal 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.
- Background: PubMed 26355558Kang 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.
- Background: PubMed 26311966Cho 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.
- Background: PubMed 26311985Kim 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.
- Background: PubMed 26244130Lee 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.
- Background: PubMed 26083600Flores 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.
- Background: PubMed 25782709Earles 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.