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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Treadmill training
Whole body vibration training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Treadmill Training, Whole Body Vibration Training

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change from baseline postural stability test score in Biodex Balance System at 8 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 limits of stability test score in Biodex Balance System at 8 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
Change from baseline sensory integration and balance test score in Biodex Balance System at 8 weeks
Change from baseline single leg balance test score in Biodex Balance System at 8 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 Outcome Measures

Change from baseline Stroop test score at 8 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
Change from baseline BRIEF (Behavior Rating Inventory of Executive Function) score at 8 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.
Change from baseline Conners score at 8 weeks
The scale has been used for the identification of behaviour disorders in children. Higher scores describe more severe behaviour disorder
Change from baseline the Pediatric Quality of Life Inventory (PedsQL) score at 8 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

Full Information

First Posted
March 13, 2018
Last Updated
July 10, 2018
Sponsor
Bezmialem Vakif University
Collaborators
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT03469180
Brief Title
Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder
Official Title
Comparison of Treadmill and Whole Body Vibration Training in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 24, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University
Collaborators
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Treadmill Training, Whole Body Vibration Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Childrens in this group will receive treadmill training, three times a week for 8 weeks. Each season will be supervised and last 45 minutes.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Whole body vibration training
Intervention Description
Whole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform .
Primary Outcome Measure Information:
Title
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Description
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.
Time Frame
Eight weeks
Title
Change from baseline limits of stability test score in Biodex Balance System at 8 weeks
Description
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
Time Frame
Eight weeks
Title
Change from baseline sensory integration and balance test score in Biodex Balance System at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline single leg balance test score in Biodex Balance System at 8 weeks
Description
The low stability level of four will challenge subjects and provide the data necessary to assess the subject's single leg postural stability
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Change from baseline Stroop test score at 8 weeks
Description
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
Time Frame
Eight weeks
Title
Change from baseline BRIEF (Behavior Rating Inventory of Executive Function) score at 8 weeks
Description
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.
Time Frame
Eight weeks
Title
Change from baseline Conners score at 8 weeks
Description
The scale has been used for the identification of behaviour disorders in children. Higher scores describe more severe behaviour disorder
Time Frame
Eight weeks
Title
Change from baseline the Pediatric Quality of Life Inventory (PedsQL) score at 8 weeks
Description
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
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Durgut, Msc,PT
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
ZIP/Postal Code
34060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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