NCT06628934进行中（未招募）不适用
Wearable Sensors for Quantitation of Impaired Gait and Balance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- iSARA
研究概览
简要总结
This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia.
详细描述
Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions.
- •Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions.
排除标准
- •Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.
研究组 & 干预措施
Spinocerebellar Ataxia
Individuals with genetically-confirmed diagnosis of SCA
Healthy Controls
Healthy Controls
结局指标
主要结局
iSARA
时间窗: 8 Years
Digital measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA).
次要结局
- Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)(8 Years)
- Activities-specific Balance Confidence (ABC) Scale(8 Years)
- EQ-5D-5L(8 Years)
研究者
研究点 (1)
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