Rehabilitació Assistida Amb Cavalls Posttractament oncològic en Nens i Adolescents: Efectes físics i psicològics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Self-Reported Quality Of Life Changes
研究概览
简要总结
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.
详细描述
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.
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
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Immunodepression
- •Hypotonia with severe pelvic instability that does not allow seating on the horse safely
- •Weight greater than 80Kg.
- •Phobia to horses
结局指标
主要结局
Self-Reported Quality Of Life Changes
时间窗: Baseline and 25th week
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).
次要结局
- Anxiety Changes(Baseline and 25th week)
- Depression Changes(Baseline and 25th week)
- Self-Reported Sociability Function Changes(Baseline and 25th week)
- Self-Reported Physical Function Changes(Baseline and 25th week)
- Behavior Changes(Baseline and 25th week)
- Parents-Reported Physical Function Changes(Baseline and 25th week)
- Self-Reported Emotional Function Changes(Baseline and 25th week)
- Parent-Proxys Reported Quality Of Life Changes(Baseline and 25th week)
- General Health Status Changes(Baseline and 25th week)
- Parent-Reported Emotional Function Changes(Baseline and 25th week)
- Balance Changes(Baseline, 6th, 12th and 25th week)
- Proprioception-Coordination Changes(Baseline and 25th week)
- Autonomous Neurvous System activation function Changes(Baseline, 6th, 12th and 25th week)
- Parent-Reported Sociability Function Changes(Baseline and 25th week)
- Position Changes(Baseline, 6th, 12th and 25th week)