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临床试验/NCT05602857
NCT05602857招募中不适用

Can Training Balance, or Enjoying Music, Improve Executive Functions of Children?

University of British Columbia1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
108
试验地点
1
主要终点
Change from baseline in Inhibitory Control accuracy composite score

研究概览

简要总结

This randomized controlled trial will investigate the hypothesis that since balance and executive functions (EFs) require a similar neural circuit and EFs are recruited when trying to maintain balance, that training balance might improve EFs as well as balance. There will be an active control condition (watching music videos) and a no-treatment condition. Children (18-12 years old) will be randomly assigned to one of these conditions for 12 weeks (36 per condition). The balance and music conditions will involve 15-min sessions 3x/week and a weekly check-in session with an investigator. Participants will be assessed pre-intervention, immediately post and 3-months post.

详细描述

Executive functions (EFs) are critical for success in school and in life, physical and mental health, a good quality of life, and social harmony. Indeed, EFs have even been found to be more predictive of academic & career success than socio-economic status (SES) or intelligence quotient (IQ).

It is well established that EFs depend on prefrontal cortex (PFC) and other brain regions with which it is interconnected. Recently, it has been demonstrated that much of balance (especially when there is reduced sensory input [e.g., eyes closed] or a reduced base of support [e.g., feet together or one leg raised]) requires PFC. In fact, increased PFC activity appears to compensate for sensorimotor deficits to maintain balance in older adults, and dorsolateral PFC has found to be significantly activated after external perturbation of postural stability.

It is well-established that motor learning and balance depend on the cerebellum and other interrelated brain regions. Importantly, however, the cerebellum has been shown to play an important role in EFs. The cerebellum is topographically organized in motor, cognitive and affective areas and has important anatomical connections with PFC. A growing body of recent evidence supports a close association between motor and cognitive development.

Further evidence of the close connection between EFs and motor function, especially balance, can be seen from the fact that children with impaired EFs (such as children with ADHD) tend to have impaired balance and there is an overlap between ADHD and Developmental Co-Ordination Disorder diagnosis of around 30-50%.

Further support for a close connection between balance and EFs comes from cross-sectional studies that report a positive correlation between postural stability and academic performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

This is a single-blinded randomized controlled trial. Participants will be blinded, that is, they will not know whether we expect more EF benefit from the balance training or music condition. During recruitment we will tell the families that we are investigating whether either Balance Training (BT) and/or Music Training (MT) can improve EFs, and that we have reasons to believe that both interventions can do so. Assessment of outcomes will not be blinded, however, because the investigator (Dr. Priscilla Paz) responsible for monitoring the interventions will also be conducting the assessments.

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children between 8 to 12 years old.

排除标准

  • •Children not fluent in English
  • •Children with performance over the 85th percentile at screening assessment of postural balance or EFs that it leaves little room for them to improve further.
  • •Children taking any medication that might affect cognition (e.g., psychostimulants)
  • •Children undergoing EF training, which might affect their performance on EF tests.
  • •Children undergoing other targeted training to improve their balance (e.g., dance, yoga, tai chi, martial arts), which might affect their performance on balance tests.
  • •Children with severe anxiety who might find the balance training anxiety-provoking.
  • •Children unable to perform simple balance exercises because of a physical handicap, disability, or musculoskeletal injury.
  • •Children with significant hearing loss or visual impairment even with correction.
  • •Neither the child's parent/guardian nor other responsible person strong enough to catch the child should he or she start to fall would be available to spot the child during the weekly session in case the child is assigned to the BT intervention.

研究组 & 干预措施

Balance Training

Experimental

Participants will follow a home-based BT intervention specifically designed by the investigators to improve postural control and balance in children. The BT program will consist of training sessions every other day (3 days a week) and a total of up to 45 minutes of balance exercises per week (15 minutes or less per session), addressing static balance (i.e., standing on one foot) and dynamic balance (i.e., balancing a book on your head while walking).

干预措施: Balance Training (Other)

Music Training

Active Comparator

Participants will follow a home-based MT intervention designed to provide enjoyable experiences to the child participants. The sessions will occur every other day (3 days a week) for a total of up to 45 minutes per week (15 minutes or less per session) for 12 weeks. The MT program will consist of a different selection of music videos each week, including a mix of familiar and new tunes.

干预措施: Music Training (Other)

Business as usual

No Intervention

Children assigned to this control group will follow their usual activities during the 12 weeks between initial assessment and the second assessment.

结局指标

主要结局

Change from baseline in Inhibitory Control accuracy composite score

时间窗: Baseline and post-intervention (12 weeks)

Scores for accuracy (percentage of correct responses) from each individual EF test will be analyzed separately and, using z scores, will be combined into a composite score for IC. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

Change from baseline in Sway-area Unipedal stance, eyes closed

时间窗: Baseline and post-intervention (12 weeks)

measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Unipedal stance with eyes closed

Change from baseline in time standing on a wobble board, eyes open

时间窗: Baseline and post-intervention (12 weeks)

measure the maximum time participants can maintain their balance standing on a wobble board with their eyes open.

Change from baseline in Planning / problem solving accuracy composite score

时间窗: Baseline and post-intervention (12 weeks)

Scores for accuracy (percentage of correct responses) from each EF test will be analyzed separately and, using z scores, will be combined into a composite score for planning/problem-solving. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

Change from baseline in Sway-area Bipedal stance, eyes open

时间窗: Baseline and post-intervention (12 weeks)

measure postural sway (displacements in the center of pressure (COP)) in millimetres on static bipedal stance (feet shoulder width apart) with eyes open

Change from baseline in Sway-area Unipedal stance, eyes open

时间窗: Baseline and post-intervention (12 weeks)

measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Unipedal stance with eyes open

Change from baseline in Working Memory accuracy composite score

时间窗: Baseline and post-intervention (12 weeks)

Scores for accuracy (percentage of correct responses) from each individual EF test will be analyzed separately and, using z scores, will be combined into a composite score for WM. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

Change from baseline in Cognitive Flexibility accuracy composite score

时间窗: Baseline and post-intervention (12 weeks)

Scores for accuracy (percentage of correct responses) from each EF test will be analyzed separately and, using z scores, will be combined into a composite score for CF, and planning/problem-solving. EF tests included N-back, Re-ordering digits, hearts and flowers, flanker/reverse flanker, street test, farmer Joe, tower of London and design fluency test

Change from baseline in Sway-area Bipedal stance, eyes closed

时间窗: Baseline and post-intervention (12 weeks)

measure os postural sway (displacements in the center of pressure (COP)) in millimetres on static bipedal stance (feet shoulder width apart) with eyes closed

Change from baseline in Sway-area Tandem stance, eyes closed

时间窗: Baseline and post-intervention (12 weeks)

measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Tandem stance with eyes closed

Change from baseline in Sway-area Tandem stance, eyes open

时间窗: Baseline and post-intervention (12 weeks)

measure postural sway (displacements in the center of pressure (COP)) in millimetres on static Tandem stance with eyes open

次要结局

  • Change from baseline in Inhibitory Control accuracy composite score(Baseline and 3 months post-intervention)
  • Change from baseline in Sway-area Bipedal stance, eyes closed(Baseline and 3 months post-intervention)
  • Change from baseline in Sway-area Tandem stance, eyes closed(Baseline and 3 months post-intervention)
  • Change from baseline in Sway-area Unipedal stance, eyes closed(Baseline and 3 months post-intervention)
  • Change from baseline in Sway-area Unipedal stance, eyes open(Baseline and 3 months post-intervention)
  • Change from baseline in Working Memory accuracy composite score(Baseline and 3 months post-intervention)
  • Change from baseline in Cognitive Flexibility accuracy composite score(Baseline and 3 months post-intervention)
  • Change from baseline in Planning / problem solving accuracy composite score(Baseline and 3 months post-intervention)
  • Change from baseline in Sway-area Bipedal stance, eyes open(Baseline and 3 months post-intervention)
  • Change from baseline in Sway-area Tandem stance, eyes open(Baseline and 3 months post-intervention)
  • Change from baseline in time standing on a wobble board, eyes open(Baseline and 3 months post-intervention)

研究者

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

Adele Diamond

professor and head of the Developmental Cognitive Neuroscience program

University of British Columbia

研究点 (1)

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