NCT06054971已完成不适用
Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): a Feasibility Study
Red Nucleus Enterprise Solutions, LLC1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年10月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores
研究概览
简要总结
The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
- •Confirmed diagnosis of DMD
- •Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
- •Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
- •Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
- •Participant and caregiver are based in the US throughout study
- •Participant and caregiver are fluent in the English language (verbally and in writing)
排除标准
- •Non-ambulatory DMD participant at any study timepoint
- •Caregiver/participant unwilling or unable to administer/perform the NSAA
- •Anticipated deterioration of participant's ambulatory status during the study
结局指标
主要结局
Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores
时间窗: 6 Months
次要结局
未报告次要终点
研究者
Christopher Jones, PhD
Principal Investigator
Red Nucleus Enterprise Solutions, LLC
研究点 (1)
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