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临床试验/NCT04816175
NCT04816175已完成不适用

Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4
试验地点
2
主要终点
Change from baseline on Motor Function Assessment

研究概览

简要总结

This trial will consist of a clinical series of up to 50 children with Global Developmental Delay and concomitant microcephaly or hyperkinetic movements. All children will be assessed for psychomotor function using standardized assessments, goal specific assessments, with the potential addition of neuroimaging assessment, prior to and after receiving an intensive burst of neuromotor therapy. The interventional effects will be explored by comparing the pre and post interventional assessments and neuroimaging.

详细描述

Up to 50 children between the ages of 6 months and 15 years will be recruited to participate in a burst of intensive neuromotor intervention in the form of Acquire therapy, delivered by the treatment team at Virginia Tech's Neuromotor Research Clinic. All children will have a diagnosis of Global Developmental Delay, with concomitant microcephaly or hyperkinetic movements. The children will be assessed for psychomotor function prior to and after the treatment intervention, using a series of standardized and goal specific assessments, with the possibility of additional neuroimaging assessments when possible. Acquire therapy is an intensive intervention in that it is delivered with high intensity, wherein goal directed behaviors are promoted at high levels of repetition and delivered at a high dose (4-6 hours a day) in an intensive burst of 3-4 weeks of 5 day a week treatment. Acquire therapy is an operant conditioning based intervention delivered in a cycle of refinement, reinforcement and repetition. It is play-based with activities selected to drive behavior toward goals that are specific to each child and selected based on each child's interests and needs. As such a specific protocol cannot be outlined. However, all goal directed activities are designed to promote awareness of and engagement with others and the environment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Because all children will receive the intervention all parties involved will be aware that the participant has received the intervention.

入排标准

年龄范围
6 Months 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.

排除标准

  • Medical Instability
  • Under 6 months of age over 15 years of age

结局指标

主要结局

Change from baseline on Motor Function Assessment

时间窗: 5-12 weeks

A validated motor function assessment tool the CanChild Gross Motor Function Measure -88 will be used to measure change on motor function. The child can score between 0 and 264 points. The higher the child's score the more tasks they were able to attempt and/or complete.

次要结局

  • Change from baseline on Disability Assessment(5-12 weeks)
  • Change from baseline on fMRI regional activation patterns.(5-12 weeks)
  • Change from baseline on measure of EEG coherence in delta band.(5-12 weeks)
  • Change from baseline on measure of EEG coherence in beta band.(5-12 weeks)
  • Change from baseline on measure of EEG coherence in alpha band(5-12 weeks)
  • Change from baseline on EEG power in alpha band.(5-12 weeks)
  • Change from baseline on EEG power in delta bands.(5-12 weeks)
  • Change from baseline on fMRI measures of connectivity(5-12 weeks)
  • Change from baseline on goal specific assessment(5-12 weeks)
  • Change from baseline on EEG power in beta band.(5-12 weeks)
  • Change from baseline on measure of EEG coherence in theta band.(5-12 weeks)
  • Change from baseline on EEG power in theta band.(5-12 weeks)
  • Change from baseline on Motor Assessment(5-12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie DeLuca

Principal Investigator

Virginia Polytechnic Institute and State University

研究点 (2)

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