Clinical trial NCT03870893: Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy
Official title: Effects of Hippotherapy on Physical Activities, Cardiopulmonary Fitness and Attention in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Physical Activity
Attention Disorder
Keywords: cerebral palsy
hippotherapy
cardiopulmonary fitness
physical activity
attention
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2019-03-12
Enrollment: 47
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

Detailed description: This research aims to promote hippotherapy by scientifically proving its therapeutic effects and mechanism to contribute to improving the health and quality of life of the patients as well as reducing their global burden of disease by shifting the current passive "therapy-oriented" paradigm to a more proactive "participation-oriented" paradigm.

Ever since physical activity and physical fitness have been reported to have an inverse relationship with the mortality rate, especially deaths due to cardiovascular disease, various efforts have been made to optimize physical activity and physical fitness among children with cerebral palsy. ADHD is one of the most common coexisting conditions of cerebral palsy. More participation in engaging sports activities like therapeutic riding is anticipated to improve patient health and their quality of life.

Hippotherapy is expected to improve clinical symptom of ADHD in children with cerebral palsy while preventing possible ensuing psychiatric disorders, thereby bringing significant improvement in their health and quality of life.

Eligibility criteria: Inclusion Criteria:

* diagnosis of spastic CP
* GMFCS level I-III
* weight \< 35kg
* ability to walk independently with or without an assistive device
* ability to comply with the study protocol and follow verbal directions

Exclusion Criteria:

* botulinum toxin injection within 3 months
* orthopedic surgery within 1 year (difficulty performing one step instructions)
* moderate to severe intellectual disability
* uncontrolled seizure
* poor visual or hearing acuity
* patients who weigh more than 35 kg
* hip dislocation
* scoliosis more than 30 degrees
* musculoskeletal surgery within 1 year

Primary outcomes:
measure: Change of Clinical Global Improvement(CGI)
timeFrame: Change in baseline CGI at 16weeks
Secondary outcomes:
measure: Change of Attention
timeFrame: Change in baseline attention at 16weeks
measure: Change of Physical Activity(%)
timeFrame: Change in baseline physical activity at 16weeks
measure: Change of Peak Oxygen Uptake(VO2peak)
timeFrame: Change in baseline peak oxygen uptake at 16weeks
measure: Change of Gross Motor Function Measure 66
timeFrame: Change in baseline Gross Motor Function Measure 66 at 16weeks
measure: Change of Physical Activity(Steps)
timeFrame: Change in baseline steps at 16weeks
measure: Change of Resting Heart Rate(RHR)
timeFrame: Change in baseline resting heart rate at 16weeks
measure: Change of Respiratory Exchange Ratio(RER)
timeFrame: Change in baseline respiratory exchange ratio at 16weeks
measure: Change of Heart Rate Recovery(HRR)
timeFrame: Change in baseline heart rate recovery at 16weeks
measure: Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)
timeFrame: Change in baseline child health questionnaire-parent form 50 at 16weeks
measure: Change of Timed up and go(TUG)
timeFrame: Change in baseline timed up and go at 16weeks
measure: Change of 6 Minute Walk Test(6MWT)
timeFrame: Change in baseline 6 minute walk test at 16weeks
measure: Change of Blood Pressure(BP)
timeFrame: Change in baseline blood pressure at 16weeks
measure: Change of Pediatric Balance Scale(PBS)
timeFrame: Change in baseline pediatric balance scale at 16weeks
measure: Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale
timeFrame: Change in baseline ADHD rating scale at 16weeks
measure: Change of Self-Esteem Scale
timeFrame: Change in baseline self-esteem at 16weeks
measure: Change of PedsQL 4.0
timeFrame: Change in baseline quality life of child at 16weeks
measure: Change of Continuous Performance Test 3rd Edition
timeFrame: Change in baseline attention at 16weeks
measure: Change of Quantitative Electroencephalography
timeFrame: Change in baseline Quantitative electroencephalography at 16weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Researcher
name: Minhwa Suk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suk MH, Kwon JY. Effect of Equine-Assisted Activities and Therapies on Cardiorespiratory Fitness in Children with Cerebral Palsy: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jan;28(1):51-59. doi: 10.1089/jicm.2021.0158.
citation: Ahn B, Joung YS, Kwon JY, Lee DI, Oh S, Kim BU, Cha JY, Kim JH, Lee JY, Shin HY, Seo YS. Effects of equine-assisted activities on attention and quality of life in children with cerebral palsy in a randomized trial: examining the comorbidity with attention-deficit/hyperactivity disorder. BMC Pediatr. 2021 Mar 19;21(1):135. doi: 10.1186/s12887-021-02597-0.
citation: Park IK, Lee JY, Suk MH, Yoo S, Seo YG, Oh JK, Kwon JY. Effect of Equine-Assisted Activities on Cardiac Autonomic Function in Children with Cerebral Palsy: A Pilot Randomized-Controlled Trial. J Altern Complement Med. 2021 Jan;27(1):96-102. doi: 10.1089/acm.2020.0346. Epub 2020 Nov 27.