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临床试验/NCT03469180
NCT03469180已完成不适用

Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月24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
30
试验地点
1
主要终点
Change from baseline single leg balance test score in Biodex Balance System at 8 weeks

研究概览

简要总结

It is reported in the literature that children with attention deficit hyperactivity disorder (ADHD) may have executive function deficits, impaired social functions, emotional dysregulation, behavioral disorders and motor impairments. Furthermore, studies have shown that exercise, such as acute and chronic aerobic exercises and acute whole body vibration training, improves executive functions and motor abilities and so it is hypothesized that exercise may have a potential or additional treatment option for children with ADHD. Neurobiological researches have already proven the effects on brain changes during exercise and in the case of ADHD, increasing levels of serotonin, dopamine, and norepinephrine within the front striatal lobes of the brain were highlighted when discussing the effects on this neurodevelopmental disorder. The literature emphasizes the importance of physical activity in children with ADHD, but there is no clarity regarding the frequency, intensity or duration of the exercise. Thus, the aim of this study was to investigate and compare the effects of treadmill training as an aerobic exercise and whole body vibration training on executive functions and balance in children with ADHD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •ADHD diagnosis (Previously not taking or not taking medication for ADHD)
  • •Being going to primary school

排除标准

  • •Having a chronic and serious medical condition
  • •Seizure-like neurological impairment
  • •Autism spectrum disorder, vision, speech, hearing problems

研究组 & 干预措施

Control Group

Active Comparator

Childrens in this group will receive treadmill training, three times a week for 8 weeks. Each season will be supervised and last 45 minutes.

干预措施: Treadmill training (Other)

Training Group

Experimental

İn addition to treadmill training, childrens in this group (after a rest for 5 minutes) will also receive whole body vibration training for 15 minutes.

干预措施: Treadmill training (Other)

Training Group

Experimental

İn addition to treadmill training, childrens in this group (after a rest for 5 minutes) will also receive whole body vibration training for 15 minutes.

干预措施: Whole body vibration training (Other)

结局指标

主要结局

Change from baseline single leg balance test score in Biodex Balance System at 8 weeks

时间窗: Eight weeks

The low stability level of four will challenge subjects and provide the data necessary to assess the subject's single leg postural stability

Change from baseline postural stability test score in Biodex Balance System at 8 weeks

时间窗: Eight weeks

The Postural Stability Training mode is designed to emphasize specific movement patterns or strategies by placing markers anywhere on the screen grid. The patient's score is a tally of how many times the patient can touch targets with the on-screen cursor during any session. Time counts up or down as set.The Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.

Change from baseline sensory integration and balance test score in Biodex Balance System at 8 weeks

时间窗: Eight weeks

Change from baseline limits of stability test score in Biodex Balance System at 8 weeks

时间窗: Eight weeks

The Limits of Stability Training screen is designed to challenge the user to move through a movement pattern consistent with the sway envelope.This test challenges patients to move and control their center of gravity within their base of support. During each test trial, patients must shift their weight to move the cursor from the center target to a blinking target and back as quickly and with as little deviation as possible. The same process is repeated for each of nine targets

次要结局

  • Change from baseline the Pediatric Quality of Life Inventory (PedsQL) score at 8 weeks(Eight weeks)
  • Change from baseline Stroop test score at 8 weeks(Eight weeks)
  • Change from baseline BRIEF (Behavior Rating Inventory of Executive Function) score at 8 weeks(Eight weeks)
  • Change from baseline Conners score at 8 weeks(Eight weeks)

研究者

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

Elif Durgut

Lecturer,MSc,PT

Bezmialem Vakif University

研究点 (1)

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