Efficacy of Lycra Garments in Ataxic Subjects
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Berg Balance Scale/ with lycra garments
研究概览
简要总结
The aim of this study iss to analyze the effect of Lycra garments in the axial stabilization in subjects affected by ataxia, both in acquired cerebellar injuries and malformative etiology.
Improvement are expected for what concerns:
- greater stability during stance
- smoother walking pattern
- reduction of risk of fall.
The two groups (acquired and malformative) will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects recruited must show a framework of ataxia consequent to acquired brain injury or malformative etiology.
- •subjects must be able to walk autonomously without any device
排除标准
- •presence of spasticity or muscular contractures
- •subjects who already used lycra garments
结局指标
主要结局
Berg Balance Scale/ with lycra garments
时间窗: immediately after wearing the lycra garment
Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome)
6 Minute Walking Test/no device
时间窗: immediately before wearing the lycra garment
a test to assess the walking resistance
Goal Attainment Scaling/ with lycra garments
时间窗: immediately after wearing the lycra garment
Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better)
Movement of the center of mass over GRAIL/no device
时间窗: immediately before wearing the lycra garment
Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetitions lasting 1 minute
Berg Balance Scale/no device
时间窗: immediately before wearing the lycra garment
Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome)
6 Minute Walking Test/ with lycra garments
时间窗: immediately after wearing the lycra garment
a test to assess the walking resistance
Movement of the center of mass over GRAIL/ with lycra garments
时间窗: immediately after wearing the lycra garment
Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetition lasting 1 minute
Goal Attainment Scaling/no device
时间窗: immediately before wearing the device
Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better)
次要结局
- Likert tolerability questionaire(14 days after wearing the lycra garment)