Clinical trial NCT04070131: Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects
Official title: Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Child, Only
Child Behavior
Neurologic Gait Disorder
Neurologic Complication
Keywords: Child Behavior
Neurologic Gait Disorder
Cancer
Physical Therapy Modalities
Physical Therapy Specialty
Physical and Rehabilitation Medicine
Rehabilitation
Lead sponsor: Escoles Universitaries Gimbernat
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Hospital Sant Joan de Deu
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled parallel clinical trial, randomised, not-masked, with Control Group and Intervention Group.
Primary purpose: TREATMENT

Brief summary: Clinical trial on the physical and psychological effects of Horse Assisted Rehabilitation after the treatment of cancer in children 4 to 18 years of age.

Detailed description: Randomized controlled open labelled trial. Duration: 6 months. Groups: Control Group (standard follow-up) and Intervention Group (one weekly rehabilitation session assisted by horse). Participants: 30 children, 4 to 18 years of age, after 6 months of the discharge of the cancer treatment with nervous system involvement.

Eligibility criteria: Inclusion Criteria:

* Children between 4 and 18 years of age, who had suffered a cancer with affectation of the Central Nervous System
* With or without motor, functional and / or cognitive deficits or neurological disorders due to their basic problem or be as a consequence of the therapeutic procedures, with any degree of disability
* More than 6 months after receiving the discharge of oncology (chemotherapy or radiotherapy)

Exclusion Criteria:

* Immunodepression
* Hypotonia with severe pelvic instability that does not allow seating on the horse safely
* Weight greater than 80Kg.
* Phobia to horses

Primary outcomes:
measure: Self-Reported Quality Of Life Changes
timeFrame: Baseline and 25th week
Secondary outcomes:
measure: Parent-Proxys Reported Quality Of Life Changes
timeFrame: Baseline and 25th week
measure: General Health Status Changes
timeFrame: Baseline and 25th week
measure: Anxiety Changes
timeFrame: Baseline and 25th week
measure: Depression Changes
timeFrame: Baseline and 25th week
measure: Behavior Changes
timeFrame: Baseline and 25th week
measure: Self-Reported Physical Function Changes
timeFrame: Baseline and 25th week
measure: Parents-Reported Physical Function Changes
timeFrame: Baseline and 25th week
measure: Self-Reported Emotional Function Changes
timeFrame: Baseline and 25th week
measure: Parent-Reported Emotional Function Changes
timeFrame: Baseline and 25th week
measure: Self-Reported Sociability Function Changes
timeFrame: Baseline and 25th week
measure: Parent-Reported Sociability Function Changes
timeFrame: Baseline and 25th week
measure: Balance Changes
timeFrame: Baseline, 6th, 12th and 25th week
measure: Position Changes
timeFrame: Baseline, 6th, 12th and 25th week
measure: Proprioception-Coordination Changes
timeFrame: Baseline and 25th week
measure: Autonomous Neurvous System activation function Changes
timeFrame: Baseline, 6th, 12th and 25th week
Other outcomes:
Locations:
city: Esplugues De Llobregat
country: Spain
facility: Hospital Universitari de Sant Joan de Déu
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Escoles Universitàries Gimbernat
name: Jordi Esquirol Caussa, PhD, MD
role: STUDY_DIRECTOR
affiliation: Escoles Universitàries Gimbernat
name: Teresa Xipell Prunés, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Signorelli C, Wakefield CE, Fardell JE, Wallace WHB, Robertson EG, McLoone JK, Cohn RJ. The impact of long-term follow-up care for childhood cancer survivors: A systematic review. Crit Rev Oncol Hematol. 2017 Jun;114:131-138. doi: 10.1016/j.critrevonc.2017.04.007. Epub 2017 Apr 13.
citation: Miller K, Mehta R, Abraham J, Opneja A, Jain RK. Patterns of Long-term Cancer Survivorship Care in a National Cancer Institute-Designated Comprehensive Cancer Center. Am J Clin Oncol. 2017 Dec;40(6):639-643. doi: 10.1097/COC.0000000000000217.
citation: Ford JS, Chou JF, Sklar CA. Attendance at a survivorship clinic: impact on knowledge and psychosocial adjustment. J Cancer Surviv. 2013 Dec;7(4):535-43. doi: 10.1007/s11764-013-0291-9. Epub 2013 Jun 22.
citation: Hooke MC, Gilchrist L, Foster L, Langevin M, Lee J. Yoga for Children and Adolescents After Completing Cancer Treatment. J Pediatr Oncol Nurs. 2016 Jan-Feb;33(1):64-73. doi: 10.1177/1043454214563936. Epub 2015 Feb 2.
citation: Rigby BR, Grandjean PW. The Efficacy of Equine-Assisted Activities and Therapies on Improving Physical Function. J Altern Complement Med. 2016 Jan;22(1):9-24. doi: 10.1089/acm.2015.0171. Epub 2015 Dec 14.
citation: Hilliere C, Collado-Mateo D, Villafaina S, Duque-Fonseca P, Parraca JA. Benefits of Hippotherapy and Horse Riding Simulation Exercise on Healthy Older Adults: A Systematic Review. PM R. 2018 Oct;10(10):1062-1072. doi: 10.1016/j.pmrj.2018.03.019. Epub 2018 Apr 5.
citation: Koca TT, Ataseven H. What is hippotherapy? The indications and effectiveness of hippotherapy. North Clin Istanb. 2016 Jan 15;2(3):247-252. doi: 10.14744/nci.2016.71601. eCollection 2015.
citation: Cerulli C, Minganti C, De Santis C, Tranchita E, Quaranta F, Parisi A. Therapeutic horseback riding in breast cancer survivors: a pilot study. J Altern Complement Med. 2014 Aug;20(8):623-9. doi: 10.1089/acm.2014.0061. Epub 2014 Jun 25.
citation: Lee PT, Dakin E, McLure M. Narrative synthesis of equine-assisted psychotherapy literature: Current knowledge and future research directions. Health Soc Care Community. 2016 May;24(3):225-46. doi: 10.1111/hsc.12201. Epub 2015 Mar 2.
citation: Kang KD, Jung TW, Park IH, Han DH. Effects of Equine-Assisted Activities and Therapies on the Affective Network of Adolescents with Internet Gaming Disorder. J Altern Complement Med. 2018 Aug;24(8):841-849. doi: 10.1089/acm.2017.0416. Epub 2018 Apr 26.
citation: Pendry P, Carr AM, Smith AN, Roeter SM. Improving adolescent social competence and behavior: a randomized trial of an 11-week equine facilitated learning prevention program. J Prim Prev. 2014 Aug;35(4):281-93. doi: 10.1007/s10935-014-0350-7.
citation: Garner BA, Rigby BR. Human pelvis motions when walking and when riding a therapeutic horse. Hum Mov Sci. 2015 Feb;39:121-37. doi: 10.1016/j.humov.2014.06.011. Epub 2014 Nov 28.
citation: Fazio E, Medica P, Cravana C, Ferlazzo A. Hypothalamic-pituitary-adrenal axis responses of horses to therapeutic riding program: effects of different riders. Physiol Behav. 2013 Jun 13;118:138-43. doi: 10.1016/j.physbeh.2013.05.009. Epub 2013 May 15.
citation: Herrero Gallego P, García Antón E, Monserrat Cantera ME, Oliván Blázquez B, Gómez Trullén EM, Trenado Molina J. Efectos terapéuticos de la hipoterapia en la parálisis cerebral, una revisión sistemática. Fisioterapia. 2012; 34:225-34.
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: Martin-Valero R, Vega-Ballon J, Perez-Cabezas V. Benefits of hippotherapy in children with cerebral palsy: A narrative review. Eur J Paediatr Neurol. 2018 Nov;22(6):1150-1160. doi: 10.1016/j.ejpn.2018.07.002. Epub 2018 Jul 10.
citation: Dewar R, Love S, Johnston LM. Exercise interventions improve postural control in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2015 Jun;57(6):504-20. doi: 10.1111/dmcn.12660. Epub 2014 Dec 18.
citation: Mutoh T, Mutoh T, Takada M, Doumura M, Ihara M, Taki Y, Tsubone H, Ihara M. Application of a tri-axial accelerometry-based portable motion recorder for the quantitative assessment of hippotherapy in children and adolescents with cerebral palsy. J Phys Ther Sci. 2016 Oct;28(10):2970-2974. doi: 10.1589/jpts.28.2970. Epub 2016 Oct 28.
citation: Mutoh T, Mutoh T, Tsubone H, Takada M, Doumura M, Ihara M, Shimomura H, Taki Y, Ihara M. Impact of serial gait analyses on long-term outcome of hippotherapy in children and adolescents with cerebral palsy. Complement Ther Clin Pract. 2018 Feb;30:19-23. doi: 10.1016/j.ctcp.2017.11.003. Epub 2017 Nov 8.
citation: Matusiak-Wieczorek E, Malachowska-Sobieska M, Synder M. Influence of Hippotherapy on Body Balance in the Sitting Position Among Children with Cerebral Palsy. Ortop Traumatol Rehabil. 2016 Mar 23;18(2):165-175. doi: 10.5604/15093492.1205024.
citation: Rigby BR, Gloeckner AR, Sessums S, Lanning BA, Grandjean PW. Changes in Cardiorespiratory Responses and Kinematics With Hippotherapy in Youth With and Without Cerebral Palsy. Res Q Exerc Sport. 2017 Mar;88(1):26-35. doi: 10.1080/02701367.2016.1266458. Epub 2017 Jan 11.
citation: Strashko EY, Kapustianska capital A, CyrillicA, Bobyreva LE. Experience of using hippotherapy in complex effects on muscle spirals in children with spastic forms of cerebral palsy. Wiad Lek. 2016;69(3 pt 2):527-529.
citation: 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.
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: De Miguel A, De Miguel MD, Lucena-Anton D, Rubio MD. [Effects of hypotherapy on the motor function of persons with Down's syndrome: a systematic review]. Rev Neurol. 2018 Oct 1;67(7):233-241. Spanish.
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: Hsieh YL, Yang CC, Sun SH, Chan SY, Wang TH, Luo HJ. Effects of hippotherapy on body functions, activities and participation in children with cerebral palsy based on ICF-CY assessments. Disabil Rehabil. 2017 Aug;39(17):1703-1713. doi: 10.1080/09638288.2016.1207108. Epub 2016 Jul 20.
citation: Lucena-Anton D, Rosety-Rodriguez I, Moral-Munoz JA. Effects of a hippotherapy intervention on muscle spasticity in children with cerebral palsy: A randomized controlled trial. Complement Ther Clin Pract. 2018 May;31:188-192. doi: 10.1016/j.ctcp.2018.02.013. Epub 2018 Feb 19.
citation: Ribeiro MF, Espindula AP, Lage JB, Bevilacqua Junior DE, Diniz LH, Mello EC, Ferreira AA, Ferraz MLF, Teixeira VPA. Analysis of the electromiographic activity of lower limb and motor function in hippotherapy practitioners with cerebral palsy. J Bodyw Mov Ther. 2019 Jan;23(1):39-47. doi: 10.1016/j.jbmt.2017.12.007. Epub 2017 Dec 9.
citation: Zaliene L, Mockeviciene D, Kreiviniene B, Razbadauskas A, Kleiva Z, Kirkutis A. Short-Term and Long-Term Effects of Riding for Children with Cerebral Palsy Gross Motor Functions. Biomed Res Int. 2018 Jul 8;2018:4190249. doi: 10.1155/2018/4190249. eCollection 2018.
citation: Trzmiel T, Purandare B, Michalak M, Zasadzka E, Pawlaczyk M. Equine assisted activities and therapies in children with autism spectrum disorder: A systematic review and a meta-analysis. Complement Ther Med. 2019 Feb;42:104-113. doi: 10.1016/j.ctim.2018.11.004. Epub 2018 Nov 5.
citation: Harris A, Williams JM. The Impact of a Horse Riding Intervention on the Social Functioning of Children with Autism Spectrum Disorder. Int J Environ Res Public Health. 2017 Jul 14;14(7):776. doi: 10.3390/ijerph14070776.
citation: Llambias C, Magill-Evans J, Smith V, Warren S. Equine-Assisted Occupational Therapy: Increasing Engagement for Children With Autism Spectrum Disorder. Am J Occup Ther. 2016 Nov/Dec;70(6):7006220040p1-7006220040p9. doi: 10.5014/ajot.2016.020701.
citation: Anderson S, Meints K. Brief Report: The Effects of Equine-Assisted Activities on the Social Functioning in Children and Adolescents with Autism Spectrum Disorder. J Autism Dev Disord. 2016 Oct;46(10):3344-52. doi: 10.1007/s10803-016-2869-3.
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: Ward SC, Whalon K, Rusnak K, Wendell K, Paschall N. The association between therapeutic horseback riding and the social communication and sensory reactions of children with autism. J Autism Dev Disord. 2013 Sep;43(9):2190-8. doi: 10.1007/s10803-013-1773-3.
citation: Srinivasan SM, Cavagnino DT, Bhat AN. Effects of Equine Therapy on Individuals with Autism Spectrum Disorder: A Systematic Review. Rev J Autism Dev Disord. 2018 Jun;5(2):156-175. doi: 10.1007/s40489-018-0130-z. Epub 2018 Feb 20.
citation: Tan VX, Simmonds JG. Parent Perceptions of Psychosocial Outcomes of Equine-Assisted Interventions for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2018 Mar;48(3):759-769. doi: 10.1007/s10803-017-3399-3.
citation: Garcia-Gomez A, Rodriguez-Jimenez M, Guerrero-Barona E, Rubio-Jimenez JC, Garcia-Pena I, Moreno-Manso JM. Benefits of an experimental program of equestrian therapy for children with ADHD. Res Dev Disabil. 2016 Dec;59:176-185. doi: 10.1016/j.ridd.2016.09.003. Epub 2016 Sep 7.
citation: Hyun GJ, Jung TW, Park JH, Kang KD, Kim SM, Son YD, Cheong JH, Kim BN, Han DH. Changes in Gait Balance and Brain Connectivity in Response to Equine-Assisted Activity and Training in Children with Attention Deficit Hyperactivity Disorder. J Altern Complement Med. 2016 Apr;22(4):286-93. doi: 10.1089/acm.2015.0299. Epub 2016 Mar 16.
citation: Oh Y, Joung YS, Jang B, Yoo JH, Song J, Kim J, Kim K, Kim S, Lee J, Shin HY, Kwon JY, Kim YH, Jeong B. Efficacy of Hippotherapy Versus Pharmacotherapy in Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial. J Altern Complement Med. 2018 May;24(5):463-471. doi: 10.1089/acm.2017.0358. Epub 2018 Apr 11.
citation: Munoz-Lasa S, Lopez de Silanes C, Atin-Arratibel MA, Bravo-Llatas C, Pastor-Jimeno S, Maximo-Bocanegra N. Effects of hippotherapy in multiple sclerosis: pilot study on quality of life, spasticity, gait, pelvic floor, depression and fatigue. Med Clin (Barc). 2019 Jan 18;152(2):55-58. doi: 10.1016/j.medcli.2018.02.015. Epub 2018 Apr 19. English, Spanish.
citation: Vermohlen V, Schiller P, Schickendantz S, Drache M, Hussack S, Gerber-Grote A, Pohlau D. Hippotherapy for patients with multiple sclerosis: A multicenter randomized controlled trial (MS-HIPPO). Mult Scler. 2018 Sep;24(10):1375-1382. doi: 10.1177/1352458517721354. Epub 2017 Aug 3.
citation: Erdman EA, Pierce SR. Use of Hippotherapy With a Boy After Traumatic Brain Injury: A Case Study. Pediatr Phys Ther. 2016 Spring;28(1):109-16. doi: 10.1097/PEP.0000000000000204.
citation: Cabiddu R, Borghi-Silva A, Trimer R, Trimer V, Ricci PA, Italiano Monteiro C, Camargo Magalhaes Maniglia M, Silva Pereira AM, Rodrigues das Chagas G, Carvalho EM. Hippotherapy acute impact on heart rate variability non-linear dynamics in neurological disorders. Physiol Behav. 2016 May 15;159:88-94. doi: 10.1016/j.physbeh.2016.03.012. Epub 2016 Mar 15.
citation: Del Rosario-Montejo O, Molina-Rueda F, Munoz-Lasa S, Alguacil-Diego IM. Effectiveness of equine therapy in children with psychomotor impairment. Neurologia. 2015 Sep;30(7):425-32. doi: 10.1016/j.nrl.2013.12.023. Epub 2014 Mar 20. English, Spanish.
citation: Hession CE, Eastwood B, Watterson D, Lehane CM, Oxley N, Murphy BA. Therapeutic horse riding improves cognition, mood arousal, and ambulation in children with dyspraxia. J Altern Complement Med. 2014 Jan;20(1):19-23. doi: 10.1089/acm.2013.0207. Epub 2013 Oct 2.
citation: Kraft KA, Weisberg J, Finch MD, Nickel A, Griffin KH, Barnes TL. Hippotherapy in Rehabilitation Care for Children With Neurological Impairments and Developmental Delays: A Case Series. Pediatr Phys Ther. 2019 Jan;31(1):E14-E21. doi: 10.1097/PEP.0000000000000567.
citation: Hession CE, Law Smith MJ, Watterson D, Oxley N, Murphy BA. The Impact of Equine Therapy and an Audio-Visual Approach Emphasizing Rhythm and Beat Perception in Children with Developmental Coordination Disorder. J Altern Complement Med. 2019 May;25(5):535-541. doi: 10.1089/acm.2017.0242. Epub 2019 Feb 21.
citation: Wilson K, Buultjens M, Monfries M, Karimi L. Equine-Assisted Psychotherapy for adolescents experiencing depression and/or anxiety: A therapist's perspective. Clin Child Psychol Psychiatry. 2017 Jan;22(1):16-33. doi: 10.1177/1359104515572379. Epub 2016 Jul 27.
citation: Alfonso SV, Alfonso LA, Llabre MM, Fernandez MI. Project Stride: An Equine-Assisted Intervention to Reduce Symptoms of Social Anxiety in Young Women. Explore (NY). 2015 Nov-Dec;11(6):461-7. doi: 10.1016/j.explore.2015.08.003. Epub 2015 Aug 20.
citation: Frederick KE, Ivey Hatz J, Lanning B. Not Just Horsing Around: The Impact of Equine-Assisted Learning on Levels of Hope and Depression in At-Risk Adolescents. Community Ment Health J. 2015 Oct;51(7):809-17. doi: 10.1007/s10597-015-9836-x. Epub 2015 Feb 20.
citation: Dezutti JE. Eating disorders and equine therapy: a nurse's perspective on connecting through the recovery process. J Psychosoc Nurs Ment Health Serv. 2013 Sep;51(9):24-31. doi: 10.3928/02793695-20130612-01. Epub 2013 Jun 21.
citation: Rodriguez-Mansilla J, Gonzalez-Sanchez B, Torres-Piles S, Martin JG, Jimenez-Palomares M, Bellino MN. Effects of the application of therapeutic massage in children with cancer: a systematic review. Rev Lat Am Enfermagem. 2017 Jun 8;25:e2903. doi: 10.1590/1518-8345.1774.2903.
citation: Capdevila L, Rodas G, Ocaña M, Parrado E, Pintanel M, Valero M. Heart rate variability as a health inicator in sports: validation with a health-related qualify of questionnaire (Short form-12). Apunts Medicina de l'Esport 2008; 43: 62-9.
citation: Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.