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Completed

NCT Number: NCT03469180

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakıf University

Istanbul, 34060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Treadmill training

Other

Treadmill training Each season will be supervised and last 45 minutes. Treadmill speed will be adjusted to the child's maximal heart rate (MHR) (between 65 to 75 percent of the MHR).

Whole body vibration training

Other

Whole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform .

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: Eight weeks

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

    Time frame: 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

Secondary outcomes

  1. Change from baseline Stroop test score at 8 weeks

    Time frame: Eight weeks

    This test assesses the response inhibition and measures the ability to shift perceptual set in accordance with changing demands. It also measures the inhibition of a habitual behavior pattern and behaving in an unusual manner. Defects in these abilities result in lack of perseveration, stereotypic behaviors, and difficulty in controlling behavior. These functions are mainly controlled by the frontal lobes. Higher interference scores indicate poorer performance. This test has been adapted and standardized for the Turkish population

  2. Change from baseline BRIEF (Behavior Rating Inventory of Executive Function) score at 8 weeks

    Time frame: Eight weeks

    İt assesses executive function and self-regulation in children and teens. High scores indicate a higher level of dysfunction in a specific domain of executive functions.

  3. Change from baseline Conners score at 8 weeks

    Time frame: Eight weeks

    The scale has been used for the identification of behaviour disorders in children. Higher scores describe more severe behaviour disorder

  4. Change from baseline the Pediatric Quality of Life Inventory (PedsQL) score at 8 weeks

    Time frame: Eight weeks

    The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument for measuring health related quality of life of 2-18 year-old-children. Higher scores indicate higher health-related quality of life

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Collaborators

  • Medipol University

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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