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临床试验/NCT02754908
NCT02754908已完成不适用

Effectiveness of Musical Training in the Improvement of the Neurocognitive Function and Psychological Well-being of Children Surviving Brain Tumours

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group

研究概览

简要总结

This study aims to examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.

详细描述

Children surviving brain tumours have the highest risk of suffering neurocognitive late effects, such as impairment of intellectual development and deficits in attention and concentration, working memory, processing speed and executive function. Such effects severely affect their levels of academic achievement, psychosocial function and quality of life. Musical training is considered to have potential for treating neurocognitive impairment,mostly because the extensive brain networks engaged in musical training can induce substantial neuroplasticity changes in cortical and subcortical regions of motor, auditory and speech processing networks. A review of musical training for neuro-rehabilitation revealed that it can enhance motor recovery and neuroplasticity after stroke and improve motor deficits observed in Parkinson's disease. A growing body of evidence points to the beneficial effects of musical training on the cognitive development of children. The results of a longitudinal study on the effects of musical training on children's brain and cognitive development demonstrated that such training results in long-term enhancement of visualspatial, verbal and mathematical performance. Moreover, engaging in musical practice in childhood predicts academic performance and IQ at the university level. Thus, there appears to be some support for the effects of music lessons on intellectual development.

Nevertheless, although musical training is popular and is considered to be a beneficial intervention in the treatment of neurocognitive impairment, longitudinal studies that examine the efficacy of music-making in clinical settings are limited. Importantly, there is to date no study that examines the effects of musical training on induction of neuroplasticity in childhood cancer survivors with neurocognitive impairment. There is an imperative need for rigorous empirical scrutiny of the ability of musical training, in particular, to achieve neuroplasticity and thus promote the cognitive function and psychological well-being of children surviving brain tumours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •surviving germ cell tumours of the brain
  • •be aged from 7 to 19 years
  • •be able to speak Cantonese and read Chinese
  • •have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
  • •have completed treatment for at least two months

排除标准

  • •have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
  • •with evidence of cancer recurrence or second malignancy in their medical records

研究组 & 干预措施

Experimental group

Experimental

In addition to medical follow-up, the subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation. Qualified orchestral performers will provide the musical training. Training will start at the lowest level (hitting simple notes) and end at the highest level (able to play an entire song). The subjects will continue on to the next level if they successfully pass the relevant test; those who do not will be encouraged to repeat test.

干预措施: musical training (Behavioral)

Placebo Control group

Placebo Comparator

The subjects will receive medical follow-up according to the schedule of the oncology units.

They will receive the same amount of time and attention as those in the experimental group but not in a way designed to have any specific effect on the outcome measures. They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).

干预措施: tutoring classes (Behavioral)

结局指标

主要结局

Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group

时间窗: 12 month follow-up

Subjects' IQ scores will be obtained at 12 months after starting the intervention using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older. In addition, the neuropsychological profile of each subject will also be examined at 12 months after starting the intervention. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.

次要结局

  • neurocognitive function at baseline between intervention and control group(baseline)
  • Change in self-esteem from baseline at 6 month follow-up between intervention and control group(6 month follow-up)
  • quality of life at baseline between intervention and control group(baseline)
  • self-esteem at baseline between intervention and control group(baseline)
  • Change in self-esteem from baseline at 12 month follow-up between intervention and control group(12 month follow-up)
  • Change in quality of life from baseline at 6 month follow-up between intervention and control group(6 month follow-up)
  • Change in quality of life from baseline at 12 month follow-up between intervention and control group(12 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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