Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy
NCT ID: NCT03889262
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-04-01
2019-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Control Group
Participants in this group will receive only Neurodevelopmental therapy (NDT) based rehabilitation for 45 minutes in each session, twice a week, during 8 weeks, 16 sessions in total. Number of participants in this group is anticipated to be 20.
Neurodevelopmental Therapy
Neurodevelopmental therapy (NDT) is a hands-on treatment approach used by physical therapists, occupational therapists, and speech-language pathologists. NDT was developed to enhance the function of children who have difficulty controlling movement as a result of neurological challenges, such as cerebral palsy and head injury. During treatment interventions, repeated experience in movement ensures that a particular pattern is readily accessible for motor performance. The more a patient performs certain movements, the easier these movements becomes.
Study Group
After 16 sessions (8 weeks) of only Neurodevelopmental therapy (NDT) based rehabilitation, simulated hippotherapy treatment will be added to rehabilitation program of the same participants. Their NDT treatment will be reduced to 25 minutes whereas hippotherapy will be applied for 20 minutes in each session, 2 sessions a week, 8 weeks in total.
Hippotherapy
Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes.
Neurodevelopmental Therapy
Neurodevelopmental therapy (NDT) is a hands-on treatment approach used by physical therapists, occupational therapists, and speech-language pathologists. NDT was developed to enhance the function of children who have difficulty controlling movement as a result of neurological challenges, such as cerebral palsy and head injury. During treatment interventions, repeated experience in movement ensures that a particular pattern is readily accessible for motor performance. The more a patient performs certain movements, the easier these movements becomes.
Interventions
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Hippotherapy
Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes.
Neurodevelopmental Therapy
Neurodevelopmental therapy (NDT) is a hands-on treatment approach used by physical therapists, occupational therapists, and speech-language pathologists. NDT was developed to enhance the function of children who have difficulty controlling movement as a result of neurological challenges, such as cerebral palsy and head injury. During treatment interventions, repeated experience in movement ensures that a particular pattern is readily accessible for motor performance. The more a patient performs certain movements, the easier these movements becomes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children aged between 5 - 18 years,
* Gross motor functional level is I, II or III,
* Independent seating
* Walking at least 10 meters independently,
* Can understand simple verbal instructions,
* Those with a spasticity level less than 2 according to Modified Ashworth Scale ,
* Having bilateral hip abduction enough to sit on the hippotherapy device,
* Voluntary acceptance to participate in the study
Exclusion Criteria
* Severe contracture or deformity,
* Scoliosis (above 20 degrees),
* Acute uncontrolled acute seizures,
* Epilepsy,
* Visual and auditory problems,
* Injection of botulinum toxin in the last 6 months,
* History of surgical operation such as muscle relaxation, tendon extension and selective dorsal rhizotomy in the last 6 months.
5 Years
18 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Principal Investigators
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Zubeyir Sarı
Role: STUDY_DIRECTOR
Marmara University Institute of Health Sciences
Central Contacts
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References
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Champagne D, Corriveau H, Dugas C. Effect of Hippotherapy on Motor Proficiency and Function in Children with Cerebral Palsy Who Walk. Phys Occup Ther Pediatr. 2017 Feb;37(1):51-63. doi: 10.3109/01942638.2015.1129386. Epub 2016 Mar 1.
Han JY, Kim JM, Kim SK, Chung JS, Lee HC, Lim JK, Lee J, Park KY. Therapeutic effects of mechanical horseback riding on gait and balance ability in stroke patients. Ann Rehabil Med. 2012 Dec;36(6):762-9. doi: 10.5535/arm.2012.36.6.762. Epub 2012 Dec 28.
Herrero P, Gomez-Trullen EM, Asensio A, Garcia E, Casas R, Monserrat E, Pandyan A. Study of the therapeutic effects of a hippotherapy simulator in children with cerebral palsy: a stratified single-blind randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1105-13. doi: 10.1177/0269215512444633. Epub 2012 May 18.
Hosaka Y, Nagasaki M, Bajotto G, Shinomiya Y, Ozawa T, Sato Y. Effects of daily mechanical horseback riding on insulin sensitivity and resting metabolism in middle-aged type 2 diabetes mellitus patients. Nagoya J Med Sci. 2010 Aug;72(3-4):129-37.
Glanzman AM, Swenson AE, Kim H. Intrarater range of motion reliability in cerebral palsy: a comparison of assessment methods. Pediatr Phys Ther. 2008 Winter;20(4):369-72. doi: 10.1097/PEP.0b013e31818b7994.
Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
Kim SG, Lee JH. The effects of horse riding simulation exercise on muscle activation and limits of stability in the elderly. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):62-5. doi: 10.1016/j.archger.2014.10.018. Epub 2014 Nov 7.
Kim SK, Kim SG, HwangBo G. The effect of horse-riding simulator exercise on the gait, muscle strength and muscle activation in elderly people with knee osteoarthritis. J Phys Ther Sci. 2017 Apr;29(4):693-696. doi: 10.1589/jpts.29.693. Epub 2017 Apr 20.
Kucukdeveci AA, Yavuzer G, Elhan AH, Sonel B, Tennant A. Adaptation of the Functional Independence Measure for use in Turkey. Clin Rehabil. 2001 Jun;15(3):311-9. doi: 10.1191/026921501676877265.
Lee CW, Kim SG, Na SS. The effects of hippotherapy and a horse riding simulator on the balance of children with cerebral palsy. J Phys Ther Sci. 2014 Mar;26(3):423-5. doi: 10.1589/jpts.26.423. Epub 2014 Mar 25.
Lee DR, Lee NG, Cha HJ, Yun Sung O, You SJ, Oh JH, Bang HS. The effect of robo-horseback riding therapy on spinal alignment and associated muscle size in MRI for a child with neuromuscular scoliosis: an experimenter-blind study. NeuroRehabilitation. 2011;29(1):23-7. doi: 10.3233/NRE-2011-0673.
Lee J, Yun CK. Effects of hippotherapy on the thickness of deep abdominal muscles and activity of daily living in children with intellectual disabilities. J Phys Ther Sci. 2017 Apr;29(4):779-782. doi: 10.1589/jpts.29.779. Epub 2017 Apr 20.
Leveille A, Rochette A, Mainville C. Perceived risks and benefits of hippotherapy among parents of children currently engaged in or waiting for hippotherapy: A pilot study. Physiother Theory Pract. 2017 Apr;33(4):269-277. doi: 10.1080/09593985.2017.1302029. Epub 2017 Apr 5.
Mutlu A, Livanelioglu A, Gunel MK. Reliability of goniometric measurements in children with spastic cerebral palsy. Med Sci Monit. 2007 Jul;13(7):CR323-9.
Mutlu A, Livanelioglu A, Gunel MK. Reliability of Ashworth and Modified Ashworth scales in children with spastic cerebral palsy. BMC Musculoskelet Disord. 2008 Apr 10;9:44. doi: 10.1186/1471-2474-9-44.
Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
Park JH, Shurtleff T, Engsberg J, Rafferty S, You JY, You IY, You SH. Comparison between the robo-horse and real horse movements for hippotherapy. Biomed Mater Eng. 2014;24(6):2603-10. doi: 10.3233/BME-141076.
Saether R, Helbostad JL, Adde L, Jorgensen L, Vik T. Reliability and validity of the Trunk Impairment Scale in children and adolescents with cerebral palsy. Res Dev Disabil. 2013 Jul;34(7):2075-84. doi: 10.1016/j.ridd.2013.03.029. Epub 2013 May 1.
Silva e Borges MB, Werneck MJ, da Silva Mde L, Gandolfi L, Pratesi R. Therapeutic effects of a horse riding simulator in children with cerebral palsy. Arq Neuropsiquiatr. 2011 Oct;69(5):799-804. doi: 10.1590/s0004-282x2011000600014.
Yi SH, Hwang JH, Kim SJ, Kwon JY. Validity of pediatric balance scales in children with spastic cerebral palsy. Neuropediatrics. 2012 Dec;43(6):307-13. doi: 10.1055/s-0032-1327774. Epub 2012 Sep 25.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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09.2017.297
Identifier Type: -
Identifier Source: org_study_id
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