APDM Instrumented Data Exchange for Ataxia (IDEA) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 5
- 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 ataxia.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SCA 1, 2, 3, 6, and FA with mutations in the pathogenic range confirmed from genetic testing
- •SCA: aged 18-75 years
- •FA: aged 12-30, diagnosed between ages 5-25
- •community dwelling
- •physically/cognitively capable of consenting/assenting and complying with the protocol based on investigator's judgement
- •able to walk independently 10 yards without an assistive device
- •able to sit or stand unassisted for 30 seconds
- •no other neurological or musculoskeletal disorder that could affect mobility
- •no other history of head injury, vestibular function, stroke, or other disorders that could affect mobility
- •willing and able to participate in a 2-year study
- •consent to be video recorded while performing study assessments
排除标准
- •dementia that limits subjects' ability to follow directions
- •pain that limits mobility
- •SCA: enrolled in a clinical drug trial
结局指标
主要结局
iSARA
时间窗: 2 years
measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA)
Ataxia App on Watch/iPhone
时间窗: 2 years
Bi-weekly assessments completed on Ataxia Application for Apple Watches and iPhones. Data collected includes active monitoring of speech, stance, coordination, gait and patient-reported symptoms.
Falls Questionnaire
时间窗: 2 years
Automatic email sent out to subjects inquiring about any falls and near falls they have experienced during the past month
Functional Staging
时间窗: 2 years
Clinician evaluates severity of ataxia symptoms.
mFARS
时间窗: 2 years
modified Friedreich's Ataxia Rating Scale (mFARS) measurements evaluated by clinician compared to measure severity of Friedreich's ataxia through coordination, speech, stance, and gait
Daily Life (UChicago site ONLY)
时间窗: 2 weeks
APDM SmartSox technology used to measure daily life activity(movement, falls, etc.) of all University of Chicago subjects
SARA
时间窗: 2 years
Scale for the Assessment and Rating of Ataxia (SARA) measurements evaluated by clinician to measure severity of spinocerebellar ataxia through coordination, speech, stance, and gait
Patient-Reported Questionnaires of Health
时间窗: 2 years
Activities, Balance, and Confidence (ABC) Questionnaire; EQ-5D-5L Health Questionnaire; Modified Fatigue Impact Scale (MFIS-5); Activities of Daily Living (ADLs)
Timed 25 Foot Walk
时间窗: 2 years
Subjects walk for 25 feet, as quickly and safely as possible, while being timed
次要结局
未报告次要终点