The effect of selected balance-corrective training on the motor function of intellectual disability student with developmental coordination disorders
Design
a randomized single-blind clinical trial with intervention and control groups, parallel groups, according to the centralized and computerized study
Settings and conduct
this study performs in hemmat spatial high-school at the rasht city with a single-blind design.
Participants/Inclusion and exclusion criteria
inclusion criteria: an intellectual disabilities, stay in educational intellectual disabilities, age range of 14-18, with the developmental coordination disorder. Exclusion criteria: having a regular exercise history, severe muscloskeletal disorder, use of certain medication that can interfere with motor function
Intervention groups
intervention group: performing a balance-corrective training- control group: without any training program.
Main outcome variables
balance, motor function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190425043370N1
Registration date:2019-05-13, 1398/02/23
Registration timing:prospective
Last update:2019-05-13, 1398/02/23
Update count:0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Hamid Zolghadr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 3395
Email address
94hamidzolghadr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selected balance-corrective training on the motor function of intellectual disability student with developmental coordination disorders
Public title
effect of balance training on motor function in intellectual disability patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being in the group of education intellectual disability (50-75)
with developmental coordination disorder
age range 14-18
a intellectual disability
Exclusion criteria:
having regular exercise history
severe muscloskeletal abnormalities
use of certain medications that can interfere with motor function
Age
From 14 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
subject are randomly assigned with help of a random number table in one of the two group and receive related intervention
Blinding (investigator's opinion)
Single blinded
Blinding description
The selected training sessions of intervention group were blinded without knowledge of being in intervention or control groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of medical sciences
Street address
Shahid Siadaty ave, Namjoo str, Rasht
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.GUMS.REC.1397.477
Health conditions studied
1
Description of health condition studied
Intellectual disability patients
ICD-10 code
F71
ICD-10 code description
Moderate intellectual disabilities
Primary outcomes
1
Description
balance
Timepoint
measurement of balance tests before and after of 8 weeks intervention
Method of measurement
functional tests of balance
2
Description
walking
Timepoint
measurement of balance tests before and after of 8 weeks intervention
Method of measurement
50 walking test
3
Description
muscular endurance
Timepoint
measurement of balance tests before and after of 8 weeks intervention
Method of measurement
sit-up test
4
Description
muscular strength and coordination
Timepoint
measurement of balance tests before and after of 8 weeks intervention
Method of measurement
TCR TEST
5
Description
FLEXIBILITY
Timepoint
measurement of balance tests before and after of 8 weeks intervention
Method of measurement
sit and rich test
Secondary outcomes
1
Description
developmental coordination disorder
Timepoint
screening of intellectual disability students with developmental coordination disorder before starting the intervention
Method of measurement
questionnaire for developmental coordination disorder (DCDQ)
Intervention groups
1
Description
"Intervention group": The correction-balanced exercise program for 2 months, 3 days a week and 60 minutes per day, with increasing exercise load in the third to fifth weeks and increasing more load ratio than last weeks in the sixth to the eight weeks.
Category
Rehabilitation
2
Description
"Control group": The control group had no physical activity during the eight weeks training period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemmad first middle pre-professional spatial high-school
Full name of responsible person
Ahmad Zad Skandar
Street address
Hemmad first middle pre-professional spatial high-school, Samiei brothers St., Mr. Seyed Sharif village, Jirdeh road, Entezam square
City
Rasht
Province
Guilan
Postal code
4194136639
Phone
+98 13 3348 3195
Email
Danivarasteh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyed Siaaedin Mirhoseini
Street address
Fifth Kilometer of Qazvin Road, Khalige Fars highway, Rast city
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 0338 3369
Email
szmirhoseini@gmail.com
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
Hamid Zolghadr
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Physical education and sport sciences faculty, fifth kilometer of Qazvin- Rasht Road, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
94hamidzolghadr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamid Zolghadr
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Physical education and sport sciences faculty, fifth kilometer of Qazvin-Rasht road, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
94hamidzolghadr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamid Zolghar
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Sport injury and corrective exercise
Street address
Physical education and sport sciences faculty, fifth kilometer Qazvin-Rasht road, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3375 3395
Email
94hamidzolghadr@gmail.com
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 data of variables measured after unidentifiable individuals can be shared.
When the data will become available and for how long
startingin january 2020
To whom data/document is available
only available for people working in academic institutions or people working in businesses
Under which criteria data/document could be used
scientific use in improving and comparing with other research is allowed.
From where data/document is obtainable
E-mail address for correspondence
What processes are involved for a request to access data/document
applicants must send the reason for using the documentation to the E-mail.