跳至主要内容
临床试验/NCT05793216
NCT05793216进行中(未招募)不适用

VestibulOTherapy: Vestibular Impact on Learning

VestibulOTherapy2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
15
试验地点
2
主要终点
Vestibular Attributes

研究概览

简要总结

Research Question: Will daily engagement in activities tailored to the evidence-based vestibular research result in improved attention and learning outcomes for children ages 6-9 years of age after an 8-week classroom-based intervention?

详细描述

"Vestibulotherapy" is an emerging frame of reference aiming to help neurotypical children with under-performing vestibular systems develop neural pathways supporting communication and learning.

Theory based upon systematic review: Given adequate vestibular activation through targeted activities (in an otherwise under-performing vestibular system), myelination and neuroplasticity propagate along learning pathways leading to greater neural connectivity and efficiency for sequencing, ordinance, attention, memory, body schema, spatial cognition, executive function, and interoception.

As a result of prescribed vestibular interventions and gained attributes supporting learning, students will experience increased academic growth and success as outlined by the following model.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Other
盲法
None

盲法说明

Outcome measures will be reviewed by a neutral party to avoid bias.

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • neurotypical development
  • between the ages of 6-10 years of age
  • performance challenges in school in the areas of math, spelling, organization, sequencing, attention, or engagement
  • demonstrate attributes of vestibular dysfunction per the Vestibular Profile
  • may have ADD or ADHD
  • May have challenges with speech articulation
  • good potential for learning and engaging in prescribed interventions

排除标准

  • Neurodiverse development (with the exception of ADHD or ADD)
  • Absence of vestibular challenges
  • Absence of learning challenges.
  • unable to participate in interventions on a routine basis due to attendance or other limitations.

结局指标

主要结局

Vestibular Attributes

时间窗: up to twelve weeks

Vestibular Profile - Pediatric (VP-P) will be completed at recruitment. The most salient attributes will be monitored weekly throughout the intervention.

Change in Academic Score reporting

时间窗: Baseline data established at recruitment, followed by weekly data collection of scores from spelling and math for twelve weeks, and again once at three-months post intervention

Academic record review: Math, spelling, and reading records from the 1st Semester of school will indicate trends in student performance. Immediately following and six months post-intervention, the trends will be compared to determine if a significant change occurs in these dependent variables. During and immediately following the intervention, spelling and math tests will be taken on consistent days of the week to avoid variabilities in data. Numerical data will be graphed to illustrate and examine trends and slope over time to determine significance of change.

Time on Task / Attention

时间窗: up to twelve weeks

Time on Task measures reflecting active participation and attention during instruction

次要结局

未报告次要终点

研究者

发起方
VestibulOTherapy
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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