Therapeutic Effects of Hippotherapy in Children With Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical global Impression-Severity of illness (CGI-S) score
研究概览
简要总结
This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.
详细描述
This study evaluates the therapeutic effects of hippotherapy in children with Prader-Willi syndrome. Half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.
The primary purpose of this study is to investigate effect of hippotherapy on motor function of Prader-Willi syndrome patients.
The secondary purpose is to compare motor function, obesity, and behavior of the children after the intervention with those parameters before the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 42 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •can sit upright on the static surface
- •can follow one step command
排除标准
- •body wight > 35 kg
- •serious medical conditions such as cardiac disease, pulmonary disease, uncontrolled epilepsy
- •visual impairment, hearing impairment
- •bleeding tendency, anticoagulation
- •fracture within 6 months, major orthopedic surgery within 1 year
研究组 & 干预措施
Control
Children in control group will not receive hippotherapy
Hippotherapy
Children in hippotherapy arm will participate in hippotherapy (30 min/sessions, twice a week, 15 weeks)
干预措施: Hippotherapy (Other)
结局指标
主要结局
Clinical global Impression-Severity of illness (CGI-S) score
时间窗: 15 weeks
The Clinical Global Impression (CGI) rating scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The two components of CGI were used in this study: Severity of Illness (CGI-S) and Global improvement (CGI-I). The clinician rates CGI-S on a 7-point scale from 1(normal) to 7(extremely ill) Thus, higher score means more severity outcomes
Clinical global Impression-Improvement (CGI-I) score
时间窗: 15 weeks
The clinician rates CGI-I on a 7-point scale from 1(very much improved) to 7(very much worse) respectively. Thus, higher score means worse outcomes.
次要结局
- Gross motor function assessed by GMFM-88 (Gross Motor Function Measure) score(15 weeks)
- Pediatric Balance Scale(15 weeks)
- Child Behavior Checklist (CBCL)(15 weeks)
- PWS (Prader-Willi syndrome) hyperphagia questionnaire(15 weeks)
- Obesity measured by DEXA (Dual-energy X-ray Absorptiometry)(15 weeks)
研究者
Jeong Yi Kwon
Professor
Samsung Medical Center