Assessing Neurophysiological Function, Cognitive Function, and Health-related Quality of Life in School Children: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This trial will investigate the feasibility of implementing our novel assessment battery in a neurodiverse pediatric population. More specifically, we want to assess our processes and procedures with respect to 1) recruitment rate (i.e., efficiency of our recruitment methods), 2) tolerability (i.e., proportion of participants able to wear the hardware without difficulty), 3) compliance (i.e., proportion of participants able to complete each task as instructed), 4) efficiency (i.e., time to completion of the test battery), and 5) data fidelity (i.e., proportion of test acquisitions with data suitable for subsequent analyses).
详细描述
The total estimated time requirement for this study is ~60 minutes (i.e., two ~30-minute sessions) and wearing a FitBit for 7 days.
Per their normal and customary procedures, Drs. Amanda and Lona will send a cover letter home to the parent(s)/guardian(s) of their patients introducing the study along with the informed consent (IC) form. Parent(s)/guardian(s) will be asked to indicate their level of interest on the letter and return it (along with the IC, if applicable) to the school. Parents/guardians who indicate that they have additional queries will be contacted by a member of our research staff via the parent's/guardian's preferred method (i.e., phone, text, and/or email). A signed IC will be required prior to enrolling any student in the study.
Up to 20 students (ages 5-17) will be tested over the course of 1 week.
This study will be conducted in designated testing rooms at participating schools within the Chippewa Falls district (Wisconsin, USA). A researcher will sit down with each student and review the age-appropriate informed assent (IA) form. Even if their parent(s)/guardian(s) would like them to participate, students must acknowledge their willingness to participate verbally (e.g., "yes I would like to do the study") and/or physically (e.g., nod their head & give a thumbs up) and sign the IA form to be enrolled in the study.
The primary aims of this trial are to investigate the feasibility of implementing our novel assessment battery with a neurodiverse pediatric population. More specifically, we want to assess our processes and procedures with respect to 1) recruitment rate (i.e., number of subjects recruited within the 1 month recruitment window), 2) tolerability (i.e., proportion of participants able to wear the hardware without difficulty), 3) compliance (i.e., proportion of participants able to complete each task as instructed), 4) efficiency (i.e., time to completion of the test battery), and 5) data fidelity (i.e., proportion of test acquisitions with data suitable for subsequent analyses). This feasibility trial is intended inform a future cluster randomized controlled trial (RCT) assessing the effects of chiropractic care on a neurodiverse pediatric population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-17 years old
- •Student of the Chippewa Falls school district
- •Parent(s)/Guardian(s) provide signed informed consent
- •Child able to provide signed informed assent & acknowledge desire to participate verbally (e.g., "Yes, I want to do the study") and/or physically (e.g., nods head & gives thumbs up).
排除标准
- •Unable to perform assessments due to movement limitations (e.g., confined to a wheelchair)
- •Unable to perform the assessments due to contraindications (e.g., has a disorder that causes fainting during postural changes such as POTS or orthostatic hypotension)
- •Pacemaker or known heart condition that influences the electrical function of the heart
- •Deemed to be at "high risk" of suicide per the C-SSRS
结局指标
主要结局
Recruitment rate
时间窗: Recruitment period (1 week)
Total number of subjects enrolled
Protocol tolerability
时间窗: Study period (2 school weeks)
Proportion of participants able to tolerate wearing a given piece of acquisition hardware (i.e., EEG cap, ECG sensors, FitBit) for the duration of the study period
Participant compliance
时间窗: Study period (2 school weeks)
Proportion of participants able to comply with the instructions for a given task
Protocol efficiency
时间窗: 1 school week
Average time to completion for both of the 1-day assessment sessions
Data fidelity
时间窗: Study period (2 school weeks)
Proportion of acquisitions for a given task with data suitable for subsequent analysis
次要结局
未报告次要终点
