Protocol summary

Study aim
The Effect of 8 Weeks of Core Stability Training on Dynamic Postural Stability, Some Kinematic Parameters of Gait Cycle and Hyperactivity Disorder / Attention Deficit (ADHD) in Children 8 -12 Years
Design
30 Students with Attention Deficit / Hyperactivity Disorder Randomly Divided into Experimental and Control Groups. The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Random Allocation Software was used to Create a Random Sequence.
Settings and conduct
The present study is a quasi-experimental research with a pre-test-post-test design with an experimental group and a control group. 30 students with combined attention deficit / hyperactivity disorder have been selected by a child and adolescent psychiatrist and are undergoing medication, are selected and randomly divided into experimental and control groups. Dynamic postural stability variables, kinematic gait parameters, and signs and symptoms of Attention Deficit / Hyperactivity Disorder are measured before and after Core stability exercises.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Attention Deficit / Hyperactivity Disorder, Girl Children Exclusion criteria: Defects in the Nervous System, Visual and Hearing Problems, Mental Retardation
Intervention groups
The Intervention Group Includes Children with Attention Deficit / Hyperactivity Disorder who Receive Core Stability Training. The Control Group Includes Children with Attention Deficit / Hyperactivity Disorder who did not Receive any Intervention.
Main outcome variables
Dynamic Postural Stability, Some Kinematic Parameters of Gait Cycle and Hyperactivity Disorder / Attention Deficit (ADHD)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N4
Registration date: 2020-10-16, 1399/07/25
Registration timing: registered_while_recruiting

Last update: 2020-10-16, 1399/07/25
Update count: 0
Registration date
2020-10-16, 1399/07/25
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 8 Weeks of Core Stability Training on Dynamic Postural Stability, Some Kinematic Parameters of Gait Cycle and Hyperactivity Disorder / Attention Deficit (ADHD) in Children 8 -12 Years
Public title
The Effect of Core Stability Training on Dynamic Postural Stability, Some Kinematic Parameters of Gait Cycle and Hyperactivity Disorder / Attention Deficit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
With Attention Deficit / Hyperactivity Disorder Girl Children
Exclusion criteria:
Defects in the Nervous System Visual and Hearing Problems Mental Retardation Fractures, Sprains or Surgery on the Lower Limbs
Age
From 8 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to Assign Individuals to two Groups that in this Method, Random Allocation Software was used to Create a Random Sequence. Then, in Order not to Determine Which Group the Individuals will be Assigned to before Dividing them into two Groups, or in other words, Allocation Concealment, the Central Randomization Method was used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport sciences research institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.SSRC.REC.1399.058

Health conditions studied

1

Description of health condition studied
Attention Deficit / Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type

Primary outcomes

1

Description
Dynamic Postural Stability
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
Biodex Balance System

2

Description
Kinematic of Gait Cycle
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
Video Camera

3

Description
Hyperactivity Disorder / Attention Deficit
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
Conners rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Core Stability Training for 8 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

2

Description
Control group: Without any training and just doing normal daily activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Raja University
Full name of responsible person
Zahra Alibakhshi
Street address
novrizian, motahhari bolv
City
Qazvin
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
zahra.alibakhshi66@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Raja university
Full name of responsible person
Hadi Miri
Street address
Novrizian, Motahhari Bolv
City
Qazvin
Province
Qazvin
Postal code
95834-34148
Phone
+98 28 3367 7101
Email
hd.miri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raja university
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Tohid Shahr - Sabzevar - Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Hakim Sabzevari University - Tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakin Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Injury and Corrective Exercise
Street address
Hakim sabzevari university - tohidshahr - Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 2756
Email
h.shahrokhi@hsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period one year after printing the results
To whom data/document is available
Data will be available to academic and scientific researchers
Under which criteria data/document could be used
Any kind of functional analysis on the submitted data is allowed
From where data/document is obtainable
by Email: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents
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