Effects of Hippotherapy on Physical Activities, Cardiopulmonary Fitness and Attention in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Change of Clinical Global Improvement(CGI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change of Clinical Global Improvement(CGI)
时间窗: Change in baseline CGI at 16weeks
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.
次要结局
- Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)(Change in baseline child health questionnaire-parent form 50 at 16weeks)
- Change of 6 Minute Walk Test(6MWT)(Change in baseline 6 minute walk test at 16weeks)
- Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale(Change in baseline ADHD rating scale at 16weeks)
- Change of PedsQL 4.0(Change in baseline quality life of child at 16weeks)
- Change of Attention(Change in baseline attention at 16weeks)
- Change of Physical Activity(%)(Change in baseline physical activity at 16weeks)
- Change of Peak Oxygen Uptake(VO2peak)(Change in baseline peak oxygen uptake at 16weeks)
- Change of Gross Motor Function Measure 66(Change in baseline Gross Motor Function Measure 66 at 16weeks)
- Change of Heart Rate Recovery(HRR)(Change in baseline heart rate recovery at 16weeks)
- Change of Pediatric Balance Scale(PBS)(Change in baseline pediatric balance scale at 16weeks)
- Change of Physical Activity(Steps)(Change in baseline steps at 16weeks)
- Change of Timed up and go(TUG)(Change in baseline timed up and go at 16weeks)
- Change of Blood Pressure(BP)(Change in baseline blood pressure at 16weeks)
- Change of Self-Esteem Scale(Change in baseline self-esteem at 16weeks)
- Change of Continuous Performance Test 3rd Edition(Change in baseline attention at 16weeks)
- Change of Quantitative Electroencephalography(Change in baseline Quantitative electroencephalography at 16weeks)
- Change of Respiratory Exchange Ratio(RER)(Change in baseline respiratory exchange ratio at 16weeks)
- Change of Resting Heart Rate(RHR)(Change in baseline resting heart rate at 16weeks)
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center