Protocol summary

Study aim
The effect of a combined physio-hemsball training on motor skill and postural control in intellectually disabled student with developmental coordination disorder
Design
Clinical practice with intervention and control groups, community-based and pragmatic, with parallel, randomized groups, on 24 individuals, The rand function of the Excel software was used for randomization.
Settings and conduct
The present study is semi-experimental and applied with pre-test and post-test. The study is being conducted in Khazali exceptional school in District 2 of Rasht. According to the entry criteria, the subjects were selected purposefully and randomly. The combined physio-hemsball training was used as a training protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: To have intellectual disability ,to be in Educatable intellectual disabilities group (50 - 70) Age range from 7 to 13 ,to have developmental coordination disorder. Exclusion criteria: To have regular exercise history,to have severe Skelo-muscular deformities , to consume drugs that can impair functional movement.
Intervention groups
Intervention group: do physio-hemsball training Control group: they dont participate in any training program
Main outcome variables
Posture control, Dynamic balance,core stability Endurance , Bruininks-Oseretsky test

General information

Reason for update
Acronym
نیمه تجربی
IRCT registration information
IRCT registration number: IRCT20200125046254N1
Registration date: 2020-04-24, 1399/02/05
Registration timing: registered_while_recruiting

Last update: 2020-04-24, 1399/02/05
Update count: 0
Registration date
2020-04-24, 1399/02/05
Registrant information
Name
Esmail Balaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3424 3853
Email address
esi123456@msc.guilan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-05, 1399/01/17
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a combined physio-hemsball training on motor skill and postural control in intellectually disabled student with developmental coordination disorder
Public title
The effect of a combined physio-hemsball training on motor skill and postural control in intellectually disabled student with developmental coordination disorder
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
To have intellectual disablility To be in Educatable intellectual disabilities group (50 - 70) Age range from 7 to 13 To have developmental coordination disorder
Exclusion criteria:
To have regular exercise history To have severe Skelo-muscular deformities To consume drugs that can impair functional movement
Age
From 7 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Not randomized
Randomization description
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
National Committee for Ethics in Biomedical Research
Street address
Namjoo Street, Shahid Siadati Street, Rasht
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2020-01-08, 1398/10/18
Ethics committee reference number
IR.GUMS.REC.1398.464

Health conditions studied

1

Description of health condition studied
people with intellectual disabilities
ICD-10 code
F71
ICD-10 code description
Moderate intellectual disabilities

Primary outcomes

1

Description
Postural Control
Timepoint
Measurement of postural control tests before and after 8 weeks of intervention
Method of measurement
Balance Error Scoring System test

2

Description
Dynamic balance
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Y balance test

3

Description
muscular endurance
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
sit ups test

4

Description
Sprint and agility
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Double sweep test

5

Description
Balance
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Standing on Balance with Stand Up test(Static)

6

Description
Balance
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Heel-toe walking on the wood test (dynamic)

7

Description
Two-way coordination
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
test of hitting one leg with a foot while drawing a circle with your fingers

8

Description
Two-way coordination
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
High jump and floor test

9

Description
strength
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Pair jump test

10

Description
Upper limb coordination
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Hand throwing ball test

11

Description
Upper limb coordination
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Test the ball to the goal with the superior hand

12

Description
Speed of response
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Response to moving visual stimuli

13

Description
Visual and motor control
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Line drawing test in a straight path

14

Description
Visual and motor control
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Circle imitation test

15

Description
Visual and motor control
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
The test of imitation of overlapping pencils with superior hand

16

Description
Upper limb agility
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Test your cards with the best hand in 5 seconds

17

Description
Upper limb agility
Timepoint
Measurement of balance test before and after 8 weeks of intervention
Method of measurement
Circle-point test with superior hand in 2 seconds

Secondary outcomes

1

Description
Developmental coordination disorder
Timepoint
Screening of intellectually disabled students with developmental coordination disorder before intervention
Method of measurement
Questionnaire of Developmental Coordination Disorder Inventory

Intervention groups

1

Description
"Intervention group": Physio-hemispheric exercise program for two months, 3 days a week, 60 minutes, with increasing training loads in the third to fifth weeks and increasing the load more than the previous weeks in the sixth to eighth weeks.
Category
Rehabilitation

2

Description
"Control group": The control group did not exercise for eight weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Exceptional Khuzali School of District 2 of Rasht
Full name of responsible person
Karimi
Street address
Dr Khazaei Elementary School District 2, Rasht
City
Rasht
Province
Guilan
Postal code
5179856137
Phone
+98 13 3381 0081
Email
esmailbalaei2020@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Ziauddin Mir Hosseini
Street address
Rasht city, Persian Gulf highway, 5 km from Qazvin road
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 0338 3369
Email
szmirhoseini@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Rasht University of Medical Sciences
Full name of responsible person
Esmail Balayi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Pathology and Corrective Exercises
Street address
Rasht- 5km Qazvin Road Rasht- Faculty of Physical Education and Sport Sciences
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
esmailbalai2020@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Esamil Balayi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Pathology and Corrective Exercises
Street address
Rasht 5km Qazvin-Rasht Road School of Physical Education and Sport Sciences
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
esamilbalaei2020@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Esmail Balayi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Pathology and Corrective Exercises
Street address
Rasht 5km Qazvin-Rasht Road School of Physical Education and Sport Sciences
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
esmailbalaei2020@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I have no plans to delete all descriptions.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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