Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects

Cancer Clinical Trial

Official title:

Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04070131
• Other study ID #: HARHB
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2022
• Source: Escoles Universitaries Gimbernat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Child Behavior
• Child, Only
• Gait Disorders, Neurologic
• Neurologic Complication
• Neurologic Gait Disorder

Intervention

Other:
• Horse-Assisted Rehabilitation
One hour weelky session of hippotherapy.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari de Sant Joan de Déu	Esplugues De Llobregat	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Escoles Universitaries Gimbernat	Hospital Sant Joan de Deu, Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & Publications (56)

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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. — View Citation

Hilliere C, Collado-Mateo D, Villafaina S, Duque-Fonseca P, Parraça 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. — View Citation

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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. — View 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. — View Citation

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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. — View 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. Review. — View Citation

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Lucena-Antón D, Rosety-Rodríguez 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. — View Citation

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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. — View Citation

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Muñoz-Lasa S, López de Silanes C, Atín-Arratibel MÁ, Bravo-Llatas C, Pastor-Jimeno S, Máximo-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. — View 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. Epub 2016 Oct 28. — View 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. — View 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. — View Citation

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* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported Quality Of Life Changes	Pediatric Quality of Life Inventory - Child-Self Report (PedsQL-C) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).	Baseline and 25th week
Secondary	Parent-Proxys Reported Quality Of Life Changes	Pediatric Quality of Life Inventory - Parent-Proxy Report (PedsQL-PC) (PedsQL is a model for measuring quality of life in children with acute or chronic pathology; The PedsQL questionnaire is composed of 23 items comprising 4 dimensions; items are reversed scored and linearly transformed to a 0-100 scale; in order to get a total score we must sum all the items scores over the number of items answered on all the Scales; total score 0-100, higher=better).	Baseline and 25th week
Secondary	General Health Status Changes	Barcelona General Health Status Questionnaire 2000 (sections: C, D, E, F, K, L, M; qualitative questionnaire, no total score).	Baseline and 25th week
Secondary	Anxiety Changes	State Trait Ansiety IInventory for children (STAI-CH) - norm-referenced scores (T scores and percentile ranks) for each one of the two subscales: Anxiety-Trait & Anxiety-State (scores 0-60 in each subscale, higher = worse).	Baseline and 25th week
Secondary	Depression Changes	Childhood Depression Inventory (CDI), self report long version (28 items) to assess the presence and severity of depressive symptoms in children. Scores range from 0-56, with higher scores indicating higher levels of depression.	Baseline and 25th week
Secondary	Behavior Changes	Behavior Assessment System for Children - Parent Rating Scale (BASC-PRS), second version (BASC-2) - BASC-2 is parent-reported, well-established scale for externalizing/internalizing problem of children and adolescents. Scoring manual and software is provided by the assessment developers; norm-referenced scores (T scores and percentile ranks) are available in the score reports, as are interpretations of strengths and weaknesses and target behaviors for intervention (mean of 50 and standard deviation of 10; for the behavior problem scales, scores above 60 are considered problematic; for the adaptive scales, scores below 40 are considered problematic).	Baseline and 25th week
Secondary	Self-Reported Physical Function Changes	PedsQL-C (subscale Health and Activities: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)	Baseline and 25th week
Secondary	Parents-Reported Physical Function Changes	PedsQL-PC (subscale Physical Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)	Baseline and 25th week
Secondary	Self-Reported Emotional Function Changes	PedsQL-C (subscale Feelings: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)	Baseline and 25th week
Secondary	Parent-Reported Emotional Function Changes	PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)	Baseline and 25th week
Secondary	Self-Reported Sociability Function Changes	PedsQL-C (subscale Get Along with Others: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)	Baseline and 25th week
Secondary	Parent-Reported Sociability Function Changes	PedsQL-PC (subscale Emotional Functioning: to create Scale Scores, the mean is computed as the sum of the items over the number of items answered; next, sum the item scores and divide by the number of items in the scale minus Nmiss)	Baseline and 25th week
Secondary	Balance Changes	Pediatric Balance Scale (PBS: 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks; Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The highest score in PBS is 56, higher is better).	Baseline, 6th, 12th and 25th week
Secondary	Position Changes	Sitting Assessment Scale (Sitting Assessment Scale (SAS) is a standardized observational instrument designed for assessment of sitting in children with cerebral palsy (CP); the scale is composed of five items evaluating head, trunk and foot control and arm and hand function, where each item is assessed with a score from 1 to 4 (1 =none; 2=poor; 3=fair; 4=good) and each score (1,2,3,4) has specific decriptors of each item of the SAS).	Baseline, 6th, 12th and 25th week
Secondary	Proprioception-Coordination Changes	Developmental Coordination Disorder Questionnaire 2007 (DCDQ'07: the DCDQ is a brief questionnaire designed to screen for coordination disorders in children, aged 5 to 15 years, and consists of 15 items grouped into three distinct factors (motor control during movement, fine motor and handwriting and general coordination; to reach scores, sum each column to compute the numbers onto the Score Sheet, and add all factor scores to compute a Total Score: 0-75, higher is better).	Baseline and 25th week
Secondary	Autonomous Neurvous System activation function Changes	Heart Rate Variability (HRV, low/high frequency (LH/FH) power ratio; modulation of heart rate variability assessed through analysis of data collected by HRV wireless monitorisation and PolarH7(R) thoracic band (medical device), following the American and European Cardiological Societies).	Baseline, 6th, 12th and 25th week