Motor perceptual abilities are based on motor functions and conceptual growth. Therefore, given that the perceptual-motor abilities are weak in mental retarded children; paying attention to motor problems in these children will be a useful step to eliminate the problems of learning and to improve their function activities at school, home and society. Our purpose in this study is to investigate the effect of the balance along with gross movement exercises on gross movement and balance function in these children. In this study, using a simple non-probability sampling method, based on a pilot sample and the sample size formula were considered 10 children in the treatment group and 10 children in the control group. Inclusion criteria include Educable Down Syndrome children with conform diagnosis by clinical psychologist, Educable Down Syndrome children without significant skeletal, neurological and mental illness and the age group is between 4.5 and 14.5 years. Exclusion criteria include non-cooperative child, Child injury accident in the length of treatment and Absence more than one session. Treatment group for 10 weeks, 3 sessions per week for 30-minute exercises; balance training (15 minutes) and gross motor (15 minutes) are taught. Control group were without intervention. After that, all the subjects will be retested. After statistical analysis, the effectiveness of the treatment on balance and gross motor function will be investigated. The survey is single blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072510387N1
Registration date:2013-06-03, 1392/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-03, 1392/03/13
Registrant information
Name
Shahla Rafiee
Name of organization / entity
Tehran University Rehabilitation College
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
sh_rafiee@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences, 4th Floor, Tehran University Central Building, Keshavarz Blvd, Tehran, Iran.
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of balance with gross motor exercises on gross motor and balance function in children with mental retardation
Public title
The effect of balance and gross motor exercises on gross motor and balance function
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
- Educable Mental Retarded children with conform diagnosis by clinical psychologist
- Educable Mental Retarded children without significant skeletal, neurological and mental illness, significant attention deficit disorder, epilepsy and other disease such as musculoskeletal and neurological disease and fractures and so on.
- The age group is between 4.5 and 14.5
Exclusion criteria:
- Non-cooperative child
- Child injury accident in the length of treatment
- Absence more than one session
Age
From 5 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, simple random sampling was used to determine the intervention and control groups. Study is a blind test and Examiners of whether a student belongs to the control group or the intervention group are unaware.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Tehran University of Medical Sciences
Street address
4th Floor, Tehran University of Medical Sciences Central Building, Keshavarz Blvd
City
Tehran
Postal code
1545913487
Approval date
2012-09-10, 1391/06/20
Ethics committee reference number
17961
Health conditions studied
1
Description of health condition studied
Mental Retardation
ICD-10 code
F70
ICD-10 code description
Approximate IQ range of 50 to 69 (in adults, mental age from 9 to 12 years). Likely to result in some learning difficulties in school. Many adults will be able to work and maintain good social relationships and contribute to society.
Primary outcomes
1
Description
Balance skills
Timepoint
Before and after intervention
Method of measurement
Bruininks RH. Bruininks _Oseretsky Test
2
Description
Gross motor skills
Timepoint
Before and after intervention
Method of measurement
Bruininks RH. Bruininks _Oseretsky Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention included Balance and gross motor exercise. These exercises are designed from easy to hard. Subjects for 10 weeks, 3 sessions per week for 30-minute exercises; balance training (15 minutes), gross motor (15 minutes) are taught.
Category
Rehabilitation
2
Description
control group:
Control group without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghods Special School
Full name of responsible person
Ghamari Narges
Street address
Shaghayegh Alley, Shahbodaghiyan Street
City
Ghods
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Fotouhi
Street address
4th Floor, Tehran University Central Building, Keshavarz Blvd
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Education and Training
Full name of responsible person
Ghamari Narges
Position
Occupational therapist/Occupational Therapy
Other areas of specialty/work
Street address
Shaghayegh Alley, Shahbodaghiyan Street
City
Ghods
Postal code
3751113885
Phone
+98 21 4688 5900
Fax
+98 21 4681 6374
Email
nargesghamari@yahoo.com
Web page address
No
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Rafiee Shahla
Position
Master of Health Education
Other areas of specialty/work
Street address
Shahnazari Street, Mirdamad Blvd.
City
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
sh_rafiee@farabi.tums.ac.ir
Web page address
No
Person responsible for updating data
Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Rafiee Shahla
Position
Mentor-Master of Science
Other areas of specialty/work
Street address
Shahnazari Street, Mirdamad Blvd.
City
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
sh_rafiee@farabi.tums.ac.ir
Web page address
No
Sharing plan
Deidentified Individual Participant Data Set (IPD)