Study of the Impact of a Gait Exoskeleton on the Quality of Life of Patients With Spinal Muscular Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Phenomenological Interviews
研究概览
简要总结
The purpose of this study is to evaluate the impact of the use of a pediatric exoskeleton on the quality of life of children, specifically in the psychological and care dimensions. Other objectives are to evaluate changes at the physical and functional level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 4 and 9 years old
- •Patients with a confirmed diagnostic of Spinal Muscular Atrophy Type II
排除标准
- •Weight over 40 Kg
- •Hip-knee distance less than 22 cm or greater than 38cm
- •Knee-ankle distance less than 21 cm or greater than 37cm
- •Distance between trochanters less than 24 cm or greater than 40cm
- •Joint range limit greater than 20º
结局指标
主要结局
Phenomenological Interviews
时间窗: 2 months
Assess the psychological impact of the experience on both children and the main care giver through phenomenological interviews. The phenomenological interview was an open interview evaluating how the participants lived the experience of using an exoskeleton at home
Participant observation
时间窗: 2 months
Assess the psychological impact of the experience on both children and the main care giver through participant observation. Participant observation was performed during exoskeleton use sessions in the children's homes. Data was taken by field notes of everything that happened during the session.
Care impact
时间窗: 2 months
To evaluate the impact of the experience in self-care of children by conducting nursing evaluations based on the Self-Care Theory developed by Dorothea Orem, before, during the use of the exoskeleton and at the end. To collect the data needed to complete the nursing assessment, structured nursing interviews were conducted with each child's primary caregiver. No scales are used to assess the care impact. A positive care impact will be considered if by using the exoskeleton any children or parents have an increase in any self-care agency. A negative care impact will be considered if by using the exoskeleton any self-care demand can not be satisfied by the self-care agency of any of the children or parents.
次要结局
- Number of Steps(2 months)
- Motor Function(2 months)
- Upper limb Function(2 months)
- Muscle Strength(2 months)
- Number of participants with abnormal vital signs(2 months)
- Respiratory rate (breaths/min)(2 months)
- Oxygen saturation(2 months)
- Emotional impact(2 months)
- Self percieved fatigue(2 months)
- Duration of time walking in each session.(2 month)
- Blood pressure(2 months)
- Social behaviour(2 months)
- Exploration(2 months)
- Sense of agency(2 months)